--- type: "firecrawl-provider" description: "ISRCTN, the UK's primary clinical study registry and a WHO primary registry (run by BioMed Central, part of Springer Nature), through its public XML API: search about 29,000 interventional and observational studies by condition, intervention, sponsor, funder, title, recruitment country, phase, registration date or computed recruitment status, and read one full record by ISRCTN, URL or a linked NCT, EudraCT, CTIS, IRAS or CPMS number, with eligibility, outcomes, centres, sponsors, funders, secondary identifiers and linked publications (PMIDs, DOIs). Records are CC BY 4.0: every result carries its licence, the study DOI and a citation." use_when: "ISRCTN, the UK's primary clinical study registry and a WHO primary registry (run by BioMed Central, part of Springer Nature), through its public XML API: search about 29,000 interventional and observational studies by condition, intervention, sponsor, funder, title, recruitment country, phase, registration date or computed recruitment status, and read one full record by ISRCTN, URL or a linked NCT, EudraCT, CTIS, IRAS or CPMS number, with eligibility, outcomes, centres, sponsors, funders, secondary identifiers and linked publications (PMIDs, DOIs). Records are CC BY 4.0: every result carries its licence, the study DOI and a citation." categories: "Health" capabilities: 2 credits_per_call: 5 --- # ISRCTN on Firecrawl Alexandria ISRCTN, the UK's primary clinical study registry and a WHO primary registry (run by BioMed Central, part of Springer Nature), through its public XML API: search about 29,000 interventional and observational studies by condition, intervention, sponsor, funder, title, recruitment country, phase, registration date or computed recruitment status, and read one full record by ISRCTN, URL or a linked NCT, EudraCT, CTIS, IRAS or CPMS number, with eligibility, outcomes, centres, sponsors, funders, secondary identifiers and linked publications (PMIDs, DOIs). Records are CC BY 4.0: every result carries its licence, the study DOI and a citation. - Categories: Health - Category index: [Health category](https://firecrawl.dev/alexandria/agents/categories/health) - Provider key: `isrctn-com` - Access: Firecrawl credits - Cost: 5 credits per call ## More - [Human guide](https://firecrawl.dev/app/alexandria/isrctn-com) - [OpenAPI spec](https://firecrawl.dev/alexandria/agents/providers/isrctn-com/openapi.json) ## Capabilities - [Search](https://firecrawl.dev/alexandria/agents/providers/isrctn-com/clinical-trials/search): Search the ISRCTN registry (GET /api/query). Combine free text with condition, intervention, sponsor, funder, title, recruitment country, phase, study type, registration or update dates, and a status filter computed the way ISRCTN computes recruitment status. Returns one page of study summaries, newest registration first, each with its ISRCTN, DOI, statuses, phases, conditions, lead sponsor, enrolment, key dates, countries and any ClinicalTrials.gov numbers, plus a page token. An empty result is a valid empty page. - [Study](https://firecrawl.dev/alexandria/agents/providers/isrctn-com/clinical-trials/study): One full ISRCTN study record (GET /api/trial/{number}) by ISRCTN, record URL or DOI, or by another identifier the study lists (NCT, EudraCT, CTIS, IRAS, CPMS or a protocol number). Returns titles, computed statuses, plain English summary, objectives, design, conditions, interventions with phases, primary and secondary outcomes, eligibility, enrolment, centres, sponsors with ROR IDs, funders with Crossref funder DOIs, named investigators with ORCIDs, secondary identifiers, results summaries and linked publications (PMIDs, PMCIDs, DOIs) and documents, with the study DOI, a citation and the CC BY 4.0 licence. ## 1. Choose this provider when ISRCTN, the UK's primary clinical study registry and a WHO primary registry (run by BioMed Central, part of Springer Nature), through its public XML API: search about 29,000 interventional and observational studies by condition, intervention, sponsor, funder, title, recruitment country, phase, registration date or computed recruitment status, and read one full record by ISRCTN, URL or a linked NCT, EudraCT, CTIS, IRAS or CPMS number, with eligibility, outcomes, centres, sponsors, funders, secondary identifiers and linked publications (PMIDs, DOIs). Records are CC BY 4.0: every result carries its licence, the study DOI and a citation. ## 2. Minimal request Call `POST https://api.firecrawl.dev/v2/scrape` with `{ alexandria: { provider, capability, options } }`. For a batch, send `{ alexandria: [...] }` with up to 10 calls. ```json { "provider": "isrctn-com", "capability": "clinical-trials/search", "options": { "condition": "asthma", "country": "United Kingdom", "page_size": 3 } } ``` ## 3. Add provider options Use only the options needed for the task: - `condition` (string): Condition or disease, matched as a phrase, e.g. "breast cancer". Example: `` - `country` (string): Recruitment country as the registry names it ("United Kingdom", "United States of America", "Korea, South"); UK, US, USA and common aliases work. "United Kingdom" also matches studies that list only England, Scotland, Wales or Northern Ireland. Example: `` - `funder` (string): Funder name, matched as a phrase, e.g. "Wellcome Trust". Example: `` - `intervention` (string): Intervention, drug or device, matched as a phrase, e.g. "tranexamic acid". Example: `` - `page_size` (number): Studies per page. Example: `10` - `page_token` (string): next_page_token from the previous page; send the same filters again. Example: `` - `phase` (string[]): Any of these phases; combined phases match both (PHASE2 matches Phase I/II, Phase II and Phase II/III). Example: `[]` - `registered_from` (string): Registered (ISRCTN assigned) on or after this date, YYYY-MM-DD. Pattern: ^[0-9]{4}-[0-9]{2}-[0-9]{2}$. Example: `` - `registered_to` (string): Registered on or before this date, YYYY-MM-DD. Pattern: ^[0-9]{4}-[0-9]{2}-[0-9]{2}$. Example: `` - `sponsor` (string): Sponsor organisation, matched as a phrase, e.g. "University of Oxford". Example: `` - `status` (string[]): Keep studies whose overall or recruitment status is any of these, computed as ISRCTN computes them (see overall_status and recruitment_status). The registry does not index computed statuses, so each page is filtered after fetching: total_count is null and a page can come back short with a next_page_token. Example: `[]` - `study_type` (string): Primary study design. Example: `INTERVENTIONAL` - `term` (string): Free text searched across the whole record, with AND, OR, NOT, quoted phrases and parentheses, e.g. "tranexamic acid" AND trauma. Field constraints from the ISRCTN API also work (condition:asthma). Unbalanced quotes or parentheses are refused: the registry would silently match nothing. Example: `` - `title` (string): Words in the public or scientific title, or the acronym, matched as a phrase, e.g. "RECOVERY". Example: `` - `updated_since` (string): Record edited on or after this date, YYYY-MM-DD. Pattern: ^[0-9]{4}-[0-9]{2}-[0-9]{2}$. Example: `<updated_since>` ## 4. Request through your preferred interface ### JavaScript ```javascript const result = await firecrawl.scrape({ alexandria: { provider: "isrctn-com", capability: "clinical-trials/search", options: { condition: "asthma", country: "United Kingdom", page_size: 3, }, }, }); ``` ### Python ```python result = firecrawl.scrape_alexandria({ "provider": "isrctn-com", "capability": "clinical-trials/search", "options": { "condition": "asthma", "country": "United Kingdom", "page_size": 3 } }) ``` ### cURL ```sh curl https://api.firecrawl.dev/v2/scrape \ -H "Authorization: Bearer $FIRECRAWL_API_KEY" \ -H "Content-Type: application/json" \ -d '{ "alexandria": { "provider": "isrctn-com", "capability": "clinical-trials/search", "options": { "condition": "asthma", "country": "United Kingdom", "page_size": 3 } } }' ``` ### CLI ```sh firecrawl scrape 'isrctn-com/clinical-trials/search' \ --options '{"condition":"asthma","country":"United Kingdom","page_size":3}' ``` ### MCP Call the FCX MCP retrieve tool with this object: ```json { "provider": "isrctn-com", "capability": "clinical-trials/search", "options": { "condition": "asthma", "country": "United Kingdom", "page_size": 3 } } ``` Ask for only the returned fields needed by the task. ## 5. Full request shape ```json { "provider": "isrctn-com", "capability": "clinical-trials/search", "options": { "condition": "asthma", "country": "United Kingdom", "page_size": 3 } } ``` ## 6. Response data The response includes `success`, `provider`, `capability`, `creditsCost` and `data`. This example shows the provider payload in `data`: ```json { "api_url": "https://www.isrctn.com/api/query/format/default?q=condition%3A%22asthma%22%20AND%20%28recruitmentCountry%3A%22United%20Kingdom%22%20OR%20recruitmentCountry%3A%22England%22%20OR%20recruitmentCountry%3A%22Scotland%22%20OR%20recruitmentCountry%3A%22Wales%22%20OR%20recruitmentCountry%3A%22Northern%20Ireland%22%29&limit=3", "license": { "attribution": "Study records from the ISRCTN registry (https://www.isrctn.com), contributed by each study's registering researchers under CC BY 4.0; cite a study by its DOI.", "name": "CC BY 4.0", "url": "https://creativecommons.org/licenses/by/4.0/" }, "next_page_token": "20260827072933741657_1_a679746c", "observed_at_ms": 1792531058355, "query": "condition:\"asthma\" AND (recruitmentCountry:\"United Kingdom\" OR recruitmentCountry:\"England\" OR recruitmentCountry:\"Scotland\" OR recruitmentCountry:\"Wales\" OR recruitmentCountry:\"Northern Ireland\")", "studies": [ { "acronym": "WRAPT", "brief_title": "Weight reduction in asthma programme with tirzepatide", "completion_date": "2028-01-01", "conditions": [ "Asthma with obesity" ], "countries": [ "United Kingdom", "England" ], "doi": "10.1186/ISRCTN91904759", "enrollment": { "count": 138, "type": "ESTIMATED" }, "has_results": false, "interventions": [ { "name": "Tirzepatide", "type": "Drug" } ], "isrctn": "ISRCTN91904759", "last_updated_date": "2026-10-09", "lead_sponsor": { "class": null, "name": "University of East Anglia" }, "nct_ids": [], "official_title": "Weight Reduction in Asthma Programme with Tirzepatide (WRAPT): clinical efficacy and mechanisms of action", "overall_status": "ONGOING", "phases": [ "PHASE2" ], "recruitment_end_date": "2027-10-31", "recruitment_start_date": "2026-11-09", "recruitment_status": "NOT_YET_RECRUITING", "registered_date": "2026-09-21", "source_url": "https://www.isrctn.com/ISRCTN91904759", "study_type": "INTERVENTIONAL", "why_stopped": null }, { "acronym": "CSAREA", "brief_title": "Study of the effect of non-adherence to standard asthma preventer treatment (inhaled steroids) on response to biologic treatment (mepolizumab) in people with severe asthma", "completion_date": "2024-08-31", "conditions": [ "Severe eosinophilic asthma" ], "countries": [ "United Kingdom", "England" ], "doi": "10.1186/ISRCTN10555748", "enrollment": { "count": 201, "type": "ACTUAL" }, "has_results": false, "interventions": [ { "name": "Mepolizumab", "type": "Biological/Vaccine" } ], "isrctn": "ISRCTN10555748", "last_updated_date": "2026-09-02", "lead_sponsor": { "class": null, "name": "University Hospitals Birmingham NHS Foundation Trust" }, "nct_ids": [], "official_title": "Non-adherence to inhaled corticosteroids is associated with negative mepolizumab response", "overall_status": "COMPLETED", "phases": [], "recruitment_end_date": "2024-08-31", "recruitment_start_date": "2022-05-03", "recruitment_status": "NO_LONGER_RECRUITING", "registered_date": "2026-09-02", "source_url": "https://www.isrctn.com/ISRCTN10555748", "study_type": "OBSERVATIONAL", "why_stopped": null }, { "acronym": "FLU2025-DMF-CFD-v1", "brief_title": "A study to develop a computer model for measuring how a drug is distributed in the lungs", "completion_date": "2026-09-25", "conditions": [ "Chronic obstructive pulmonary disease (COPD), asthma" ], "countries": [ "United Kingdom", "Wales", "Belgium" ], "doi": "10.1186/ISRCTN86996855", "enrollment": { "count": 15, "type": "ESTIMATED" }, "has_results": false, "interventions": [ { "name": "Ipratropium bromide (monohydrate), fluticasone propionate, glycopyrrolate, formoterol fumarate dihydrate", "type": "Drug" } ], "isrctn": "ISRCTN86996855", "last_updated_date": "2026-08-27", "lead_sponsor": { "class": null, "name": "Fluidda (Belgium)" }, "nct_ids": [], "official_title": "A prospective study to support validation of computational fluid dynamics based lung deposition models with nuclear medicine imaging methods", "overall_status": "COMPLETED", "phases": [ "PHASE1" ], "recruitment_end_date": "2026-09-14", "recruitment_start_date": "2026-06-30", "recruitment_status": "NO_LONGER_RECRUITING", "registered_date": "2026-08-27", "source_url": "https://www.isrctn.com/ISRCTN86996855", "study_type": "INTERVENTIONAL", "why_stopped": null } ], "total_count": 177 } ``` ## API reference-derived contract The following capability contract is generated from the same normalized Alexandria API reference exposed in the API spec. ### Search - Capability: `clinical-trials/search` - Description: Search the ISRCTN registry (GET /api/query). Combine free text with condition, intervention, sponsor, funder, title, recruitment country, phase, study type, registration or update dates, and a status filter computed the way ISRCTN computes recruitment status. Returns one page of study summaries, newest registration first, each with its ISRCTN, DOI, statuses, phases, conditions, lead sponsor, enrolment, key dates, countries and any ClinicalTrials.gov numbers, plus a page token. An empty result is a valid empty page. - Instructions: Find ISRCTN studies on a topic, from a sponsor or funder, in a country or with a recruitment status, before calling study for the full record. For a known ISRCTN, URL or NCT/EudraCT/IRAS number, call study directly. - Cost: 5 credits per call - Capability file: [Search](https://firecrawl.dev/alexandria/agents/providers/isrctn-com/clinical-trials/search) Accepted options: - `condition` (string): Condition or disease, matched as a phrase, e.g. "breast cancer". Example: `<condition>` - `country` (string): Recruitment country as the registry names it ("United Kingdom", "United States of America", "Korea, South"); UK, US, USA and common aliases work. "United Kingdom" also matches studies that list only England, Scotland, Wales or Northern Ireland. Example: `<country>` - `funder` (string): Funder name, matched as a phrase, e.g. "Wellcome Trust". Example: `<funder>` - `intervention` (string): Intervention, drug or device, matched as a phrase, e.g. "tranexamic acid". Example: `<intervention>` - `page_size` (number): Studies per page. Example: `10` - `page_token` (string): next_page_token from the previous page; send the same filters again. Example: `<page_token>` - `phase` (string[]): Any of these phases; combined phases match both (PHASE2 matches Phase I/II, Phase II and Phase II/III). Example: `[]` - `registered_from` (string): Registered (ISRCTN assigned) on or after this date, YYYY-MM-DD. Pattern: ^[0-9]{4}-[0-9]{2}-[0-9]{2}$. Example: `<registered_from>` - `registered_to` (string): Registered on or before this date, YYYY-MM-DD. Pattern: ^[0-9]{4}-[0-9]{2}-[0-9]{2}$. Example: `<registered_to>` - `sponsor` (string): Sponsor organisation, matched as a phrase, e.g. "University of Oxford". Example: `<sponsor>` - `status` (string[]): Keep studies whose overall or recruitment status is any of these, computed as ISRCTN computes them (see overall_status and recruitment_status). The registry does not index computed statuses, so each page is filtered after fetching: total_count is null and a page can come back short with a next_page_token. Example: `[]` - `study_type` (string): Primary study design. Example: `INTERVENTIONAL` - `term` (string): Free text searched across the whole record, with AND, OR, NOT, quoted phrases and parentheses, e.g. "tranexamic acid" AND trauma. Field constraints from the ISRCTN API also work (condition:asthma). Unbalanced quotes or parentheses are refused: the registry would silently match nothing. Example: `<term>` - `title` (string): Words in the public or scientific title, or the acronym, matched as a phrase, e.g. "RECOVERY". Example: `<title>` - `updated_since` (string): Record edited on or after this date, YYYY-MM-DD. Pattern: ^[0-9]{4}-[0-9]{2}-[0-9]{2}$. Example: `<updated_since>` Response schema example: ```json { "api_url": "https://www.isrctn.com/api/query/format/default?q=condition%3A%22asthma%22%20AND%20%28recruitmentCountry%3A%22United%20Kingdom%22%20OR%20recruitmentCountry%3A%22England%22%20OR%20recruitmentCountry%3A%22Scotland%22%20OR%20recruitmentCountry%3A%22Wales%22%20OR%20recruitmentCountry%3A%22Northern%20Ireland%22%29&limit=3", "license": { "attribution": "Study records from the ISRCTN registry (https://www.isrctn.com), contributed by each study's registering researchers under CC BY 4.0; cite a study by its DOI.", "name": "CC BY 4.0", "url": "https://creativecommons.org/licenses/by/4.0/" }, "next_page_token": "20260827072933741657_1_a679746c", "observed_at_ms": 1792531058355, "query": "condition:\"asthma\" AND (recruitmentCountry:\"United Kingdom\" OR recruitmentCountry:\"England\" OR recruitmentCountry:\"Scotland\" OR recruitmentCountry:\"Wales\" OR recruitmentCountry:\"Northern Ireland\")", "studies": [ { "acronym": "WRAPT", "brief_title": "Weight reduction in asthma programme with tirzepatide", "completion_date": "2028-01-01", "conditions": [ "Asthma with obesity" ], "countries": [ "United Kingdom", "England" ], "doi": "10.1186/ISRCTN91904759", "enrollment": { "count": 138, "type": "ESTIMATED" }, "has_results": false, "interventions": [ { "name": "Tirzepatide", "type": "Drug" } ], "isrctn": "ISRCTN91904759", "last_updated_date": "2026-10-09", "lead_sponsor": { "class": null, "name": "University of East Anglia" }, "nct_ids": [], "official_title": "Weight Reduction in Asthma Programme with Tirzepatide (WRAPT): clinical efficacy and mechanisms of action", "overall_status": "ONGOING", "phases": [ "PHASE2" ], "recruitment_end_date": "2027-10-31", "recruitment_start_date": "2026-11-09", "recruitment_status": "NOT_YET_RECRUITING", "registered_date": "2026-09-21", "source_url": "https://www.isrctn.com/ISRCTN91904759", "study_type": "INTERVENTIONAL", "why_stopped": null }, { "acronym": "CSAREA", "brief_title": "Study of the effect of non-adherence to standard asthma preventer treatment (inhaled steroids) on response to biologic treatment (mepolizumab) in people with severe asthma", "completion_date": "2024-08-31", "conditions": [ "Severe eosinophilic asthma" ], "countries": [ "United Kingdom", "England" ], "doi": "10.1186/ISRCTN10555748", "enrollment": { "count": 201, "type": "ACTUAL" }, "has_results": false, "interventions": [ { "name": "Mepolizumab", "type": "Biological/Vaccine" } ], "isrctn": "ISRCTN10555748", "last_updated_date": "2026-09-02", "lead_sponsor": { "class": null, "name": "University Hospitals Birmingham NHS Foundation Trust" }, "nct_ids": [], "official_title": "Non-adherence to inhaled corticosteroids is associated with negative mepolizumab response", "overall_status": "COMPLETED", "phases": [], "recruitment_end_date": "2024-08-31", "recruitment_start_date": "2022-05-03", "recruitment_status": "NO_LONGER_RECRUITING", "registered_date": "2026-09-02", "source_url": "https://www.isrctn.com/ISRCTN10555748", "study_type": "OBSERVATIONAL", "why_stopped": null }, { "acronym": "FLU2025-DMF-CFD-v1", "brief_title": "A study to develop a computer model for measuring how a drug is distributed in the lungs", "completion_date": "2026-09-25", "conditions": [ "Chronic obstructive pulmonary disease (COPD), asthma" ], "countries": [ "United Kingdom", "Wales", "Belgium" ], "doi": "10.1186/ISRCTN86996855", "enrollment": { "count": 15, "type": "ESTIMATED" }, "has_results": false, "interventions": [ { "name": "Ipratropium bromide (monohydrate), fluticasone propionate, glycopyrrolate, formoterol fumarate dihydrate", "type": "Drug" } ], "isrctn": "ISRCTN86996855", "last_updated_date": "2026-08-27", "lead_sponsor": { "class": null, "name": "Fluidda (Belgium)" }, "nct_ids": [], "official_title": "A prospective study to support validation of computational fluid dynamics based lung deposition models with nuclear medicine imaging methods", "overall_status": "COMPLETED", "phases": [ "PHASE1" ], "recruitment_end_date": "2026-09-14", "recruitment_start_date": "2026-06-30", "recruitment_status": "NO_LONGER_RECRUITING", "registered_date": "2026-08-27", "source_url": "https://www.isrctn.com/ISRCTN86996855", "study_type": "INTERVENTIONAL", "why_stopped": null } ], "total_count": 177 } ``` ### Study - Capability: `clinical-trials/study` - Description: One full ISRCTN study record (GET /api/trial/{number}) by ISRCTN, record URL or DOI, or by another identifier the study lists (NCT, EudraCT, CTIS, IRAS, CPMS or a protocol number). Returns titles, computed statuses, plain English summary, objectives, design, conditions, interventions with phases, primary and secondary outcomes, eligibility, enrolment, centres, sponsors with ROR IDs, funders with Crossref funder DOIs, named investigators with ORCIDs, secondary identifiers, results summaries and linked publications (PMIDs, PMCIDs, DOIs) and documents, with the study DOI, a citation and the CC BY 4.0 licence. - Instructions: You have an ISRCTN (from search, a pasted isrctn.com or doi.org/10.1186/ISRCTN link) or a study's NCT, EudraCT or IRAS number and need its protocol details, eligibility, outcomes, sites, funders or result publications. - Cost: 5 credits per call - Capability file: [Study](https://firecrawl.dev/alexandria/agents/providers/isrctn-com/clinical-trials/study) Accepted options: - `isrctn` (string): ISRCTN number, e.g. ISRCTN86750102 or 86750102. Pass exactly one of isrctn, url or secondary_id. Example: `<isrctn>` - `secondary_id` (string): Another identifier the study lists: an NCT number, EudraCT or CTIS number, IRAS, CPMS or NIHR number, or a sponsor protocol number. Matched exactly against the record's listed identifiers; fails with ambiguous_secondary_id when several studies list it. Example: `<secondary_id>` - `url` (string): A record URL: isrctn.com/ISRCTN..., doi.org/10.1186/ISRCTN..., the API trial URL, or the registry's old controlled-trials.com address. Example: `<url>` Response schema example: ```json { "acronym": "CRASH2", "actual_enrollment": null, "api_url": "https://www.isrctn.com/api/trial/86750102/format/default", "brief_summary": null, "brief_title": "CRASH2 Trial, a large randomised placebo-controlled trial among trauma patients with significant haemorrhage of the effects of an antifibrinolytic treatment on death and transfusion requirement", "citation": "Roberts, I (2004): CRASH2 Trial, a large randomised placebo-controlled trial among trauma patients with significant haemorrhage of the effects of an antifibrinolytic treatment on death and transfusion requirement. ISRCTN. https://doi.org/10.1186/ISRCTN86750102", "completion_date": "2010-03-02", "condition_categories": [ { "category": "Signs and Symptoms", "subcategory": "Trauma" } ], "conditions": [ "Trauma" ], "contacts": [ { "name": "Ian Roberts", "orcid": null, "roles": [ "Scientific" ] } ], "countries": [ "United Kingdom", "England", "Albania", "Argentina", "Australia", "Austria", "Bangladesh", "Belgium", "Cameroon", "Canada", "China", "Colombia", "Cuba", "Czech Republic", "Ecuador", "Egypt", "El Salvador", "Georgia", "Ghana", "India", "Indonesia", "Iran", "Iraq", "Italy", "Jamaica", "Japan", "Kenya", "Malaysia", "Mexico", "Montenegro", "Nigeria", "Peru", "Poland", "Saudi Arabia", "Serbia", "Singapore", "Slovakia", "South Africa", "Spain", "Sri Lanka", "Tanzania", "Thailand", "Tunisia", "Zambia" ], "design": { "allocation": null, "assignment": null, "control": null, "masking": null, "purposes": [], "summary": "Randomised placebo-controlled trial", "trial_types": [ "Treatment" ], "type": "Randomised controlled trial" }, "documents": [ { "date": "2025-11-11", "description": "Participant information sheet", "file_name": null, "mime_type": null, "size_bytes": null, "type": "participant_information_sheet", "url": "http://www.crash2.lshtm.ac.uk/prot_EngPIS.htm" }, { "date": "2025-11-11", "description": "Study website", "file_name": null, "mime_type": null, "size_bytes": null, "type": "study_website", "url": "http://www.crash2.lshtm.ac.uk" } ], "doi": "10.1186/ISRCTN86750102", "eligibility": { "age_group": "Adult", "exclusion_criteria": "The fundamental eligibility criterion is the responsible doctor's 'uncertainty' as to whether or not to use an antifibrinolytic agent in a particular adult with traumatic haemorrhage. Patients for whom the responsible doctor considers there is a clear indication for antifibrinolytic therapy should not be randomised. Likewise, patients for whom there is considered to be a clear contraindication to antifibrinolytic therapy (such as, perhaps, those who have clinical evidence of a thrombotic disseminated intravascular coagulation) should not be randomised. Where the responsible doctor is substantially uncertain as to whether or not to use an antifibrinolytic, all these patients are eligible for randomisation and should be considered for the trial. There are no other pre-specified exclusion criteria.", "healthy_volunteers": null, "inclusion_criteria": "All adult trauma patients who are considered to be at risk of significant haemorrhage and are within 8 hours of the injury, are eligible for trial entry if they appear to be at least 16 years old. There are no other pre-specified exclusion criteria, as the fundamental eligibility criterion is the responsible doctor's 'uncertainty' whether or not to use tranexamic acid (TXA) in a particular adult with traumatic haemorrhage. Patients for whom there is considered by the responsible doctor to be a clear indication for TXA should not be randomised. Likewise, any for whom there is considered to be a clear contraindication to TXA (such as, perhaps, those who have clinical evidence of a thrombotic disseminated intravascular coagulation) should not be randomised. All those for whom the responsible doctor is substantially uncertain as to whether or not to use an anti-fibrinolytic agent are eligible for randomisation, and as many such patients as possible should be considered for the trial.", "maximum_age": null, "minimum_age": null, "participant_types": [ "Patient" ], "sex": "ALL" }, "enrollment": { "count": 20000, "type": "ESTIMATED" }, "funders": [ { "funder_doi": null, "name": "NIHR Health Technology Assessment Programme - HTA (UK)" }, { "funder_doi": "10.13039/501100000355", "name": "Bupa Foundation (UK)" }, { "funder_doi": null, "name": "Moulton Charitable trust (UK)" }, { "funder_doi": null, "name": "London School of Hygiene and Tropical Medicine (UK)" } ], "has_results": true, "interventions": [ { "description": "Tranexamic acid 2 g intravenously over 8 hours versus placebo.\n\nPlease note that as of 24/03/10 this trial has completed recruitment, analysis is ongoing.", "name": "Tranexamic acid", "phase": null, "type": "Drug" } ], "isrctn": "ISRCTN86750102", "last_updated_date": "2014-07-09", "lead_sponsor": { "class": "University/education", "name": "London School of Hygiene and Tropical Medicine (UK)" }, "license": { "attribution": "Roberts, I (2004): CRASH2 Trial, a large randomised placebo-controlled trial among trauma patients with significant haemorrhage of the effects of an antifibrinolytic treatment on death and transfusion requirement. ISRCTN. https://doi.org/10.1186/ISRCTN86750102. CC BY 4.0, via the ISRCTN registry.", "name": "CC BY 4.0", "url": "https://creativecommons.org/licenses/by/4.0/" }, "locations": [ { "city": "London", "country": "United Kingdom", "facility": "London School of Hygiene and Tropical Medicine", "state": null } ], "nct_ids": [ "NCT00375258" ], "objectives": "Because the coagulation abnormalities that occur after injury are similar to those after surgery, it is possible that antifibrinolytic agents might also reduce blood loss, the need for transfusion and mortality following trauma. However, to date there has been only one small randomised controlled trial (70 randomised patients, drug versus placebo: 0 versus 3 deaths) of the effect of antifibrinolytic agents in major trauma. As a result, there is insufficient evidence to either support or refute a clinically important treatment effect. Systemic antifibrinolytic agents have been used in the management of eye injuries where there is some evidence that they reduce the rate of secondary haemorrhage. \n\nCRASH2 aims to determine the effect of the early administration of the antifibrinolytic agent tranexamic acid (TXA) on death and transfusion requirement in adult trauma patients with ongoing significant haemorrhage, or who are considered to be at risk of significant haemorrhage. In addition, the effect on the risk of non-fatal vascular events (either haemorrhagic or occlusive) will be assessed. \n\nThe initial stages of the trial was funded by the London School of Hygiene, the Bupa Foundation and the Moulton Charitable Trust. In 2007, this trial obtained main funding from the NIHR Health Technology Assessment Programme, which will fund this trial from April 2007 to September 2010. \n\nMore information on the CRASH2 trial can be found at: http://www.nets.nihr.ac.uk/projects/hta/0630320 \n\nAs of 16/06/2008, the CRASH2 trial will conduct sub-group analyses \"CRASH-2 Intracranial Bleeding Study (IBS)\" (start date: October 2009) to study the effect of TXA in participants who also have traumatic brain injury (TBI). About 40% of participants out of 9,000 enrolled so far have TBI. Details of this sub-study can be found at: http://www.nets.nihr.ac.uk/projects/hta/0910201 \n\nHypothesis: Early administration of TXA can prevent the occurrence or increase of intracranial bleeding in patients with TBI and significant bleeding. \n\nOn 21/08/2009 the anticipated start and end dates of this trial were changed from 01/05/2005 and 30/04/2010 to 01/04/2007 and 30/09/2010, respectively. \n\nThis trial completed follow-up on the 02/03/2010, and the record was updated to reflect this on 09/07/2010.", "observed_at_ms": 1792531058957, "official_title": null, "overall_status": "COMPLETED", "phases": [], "primary_outcomes": [ { "measure": "The primary outcome measure is death in hospital within 4 weeks of injury (causes of death will be classified).\n\nAn additional outcome measure for the sub-group analyses (added as of 18/06/2008): \n1. Increase in volume of intracranial bleeding. A repeat CT scan will be carried out 24-48 hours after injury and compared to a clinical baseline CT scan.", "method": null, "time_frame": null } ], "prospectively_registered": true, "publications": [ { "date": "2006-10-27", "description": "initial progress results", "doi": null, "peer_reviewed": true, "pmcid": null, "pmid": "17072431", "type": "results_article", "url": "http://www.ncbi.nlm.nih.gov/pubmed/17072431" }, { "date": "2010-07-03", "description": "effects of tranexamic acid results", "doi": null, "peer_reviewed": true, "pmcid": null, "pmid": "20554319", "type": "results_article", "url": "http://www.ncbi.nlm.nih.gov/pubmed/20554319" }, { "date": "2010-12-01", "description": "tranexamic acid results", "doi": null, "peer_reviewed": true, "pmcid": null, "pmid": "21702233", "type": "results_article", "url": "http://www.ncbi.nlm.nih.gov/pubmed/21702233" }, { "date": "2011-03-26", "description": "early treatment results", "doi": null, "peer_reviewed": true, "pmcid": null, "pmid": "21439633", "type": "results_article", "url": "http://www.ncbi.nlm.nih.gov/pubmed/21439633" }, { "date": "2011-05-03", "description": "cost-effectiveness analysis results", "doi": null, "peer_reviewed": true, "pmcid": null, "pmid": "21559279", "type": "results_article", "url": "http://www.ncbi.nlm.nih.gov/pubmed/21559279" }, { "date": "2011-07-01", "description": "tranexamic acid results", "doi": null, "peer_reviewed": true, "pmcid": null, "pmid": "21724564", "type": "results_article", "url": "http://www.ncbi.nlm.nih.gov/pubmed/21724564" }, { "date": "2012-07-01", "description": "tranexamic acid results", "doi": null, "peer_reviewed": true, "pmcid": null, "pmid": "22417901", "type": "results_article", "url": "http://www.ncbi.nlm.nih.gov/pubmed/22417901" }, { "date": "2012-09-11", "description": "tranexamic acid mortality results", "doi": null, "peer_reviewed": true, "pmcid": null, "pmid": "22968527", "type": "results_article", "url": "http://www.ncbi.nlm.nih.gov/pubmed/22968527" }, { "date": "2013-03-01", "description": "results", "doi": null, "peer_reviewed": true, "pmcid": null, "pmid": "23477634", "type": "results_article", "url": "http://www.ncbi.nlm.nih.gov/pubmed/23477634" }, { "date": "2014-06-01", "description": "results", "doi": null, "peer_reviewed": true, "pmcid": null, "pmid": "24346610", "type": "results_article", "url": "http://www.ncbi.nlm.nih.gov/pubmed/24346610" }, { "date": "2006-06-21", "description": "Letter to the Editor", "doi": null, "peer_reviewed": true, "pmcid": null, "pmid": "16790038", "type": "other_publication", "url": "http://www.ncbi.nlm.nih.gov/pubmed/16790038" }, { "date": "2011-02-03", "description": "reduced environmental impact of trials", "doi": null, "peer_reviewed": true, "pmcid": null, "pmid": "21291517", "type": "other_publication", "url": "http://www.ncbi.nlm.nih.gov/pubmed/21291517" } ], "recruitment_end_date": "2010-03-02", "recruitment_start_date": "2007-04-01", "recruitment_status": "NO_LONGER_RECRUITING", "registered_date": "2004-09-10", "results": { "basic_results": null, "ipd_sharing_planned": false, "ipd_sharing_statement": null, "plain_english_results": null, "stage": "Results" }, "secondary_ids": [ { "id": "NCT00375258", "type": "NCT" }, { "id": "HTA 06/303/20; HTA 09/102/01; SLCTR/2007/008", "type": "Protocol serial number" } ], "secondary_outcomes": [ { "measure": "Secondary outcome measures will be receipt of a blood transfusion, volume of blood transfused, surgical intervention and the occurrence of vascular events (haemorrhagic stroke, occlusive stroke, myocardial infarction, pulmonary embolism, clinically diagnosed deep vein thrombosis). Data will be recorded on a single sided outcome form which can be completed entirely from the hospital notes. There will be no additional tests.\n\nAdditional outcome measures for the sub-group analyses (added as of 18/06/2008): \nA repeat CT scan will be carried out 24 - 48 hours after injury and compared to a clinical baseline CT scan to assess the following:\n1. Frequency of progressive haematomas\n2. Frequency of delayed haematomas\n3. New focal ischaemic lesions", "method": null, "time_frame": null } ], "source_url": "https://www.isrctn.com/ISRCTN86750102", "sponsors": [ { "commercial_status": "Non-commercial", "name": "London School of Hygiene and Tropical Medicine (UK)", "ror_id": "https://ror.org/00a0jsq62", "type": "University/education" } ], "study_type": "INTERVENTIONAL", "target_enrollment": 20000, "why_stopped": null } ```