Trial · NCT01402882
Clinical Randomisation of an Antifibrinolytic in Significant Head Injury
NCT01402882, Phase 3, Completed, London School of Hygiene and Tropical Medicine
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Randomisation of an Antifibrinolytic in Significant Head Injury. Trials, record NCT01402882. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01402882
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Randomisation of an Antifibrinolytic in Significant Head Injury
- NCT number
- NCT01402882
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 12,737 participants, actual
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Conditions
- Traumatic Brain Injury
- Interventions
- Tranexamic Acid
- First posted
- 2011-07-26
- Last updated
- 2020-02-17
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The primary outcome is death in hospital in patients recruited within 3 hours and cause of death will be described. | within 28 days of injury | |
| Secondary | (a) Vascular occlusive events (myocardial infarction, stroke, pulmonary embolism, clinical evidence of deep vein thrombosis) | Prior death, discharge or 28 days | |
| Secondary | (b) In hospital disability assessed using the Disability Rating Scale and Patient Orientated Outcome | Prior death, discharge or 28 days | |
| Secondary | (c) Seizures | Prior death, discharge or day 28 | |
| Secondary | (d) Neurosurgical intervention | prior death, discharge or day 28 | |
| Secondary | (e) Days in intensive care | prior death, discharge or day 28 | |
| Secondary | (f) Other adverse events | prior death, discharge or day 28 | |
| Other | CRASH-3 IBS: Primary outcome - the total volume of intracranial haemorrhage | 1) CT scan done before receipt of trial treatment; (2) CT scan done after receipt of trial treatment (up to 28 days after randomisation) | |
| Other | Frequency of progressive haemorrhage: number of patients with a post-randomisation CT scan with total haemorrhage volume of more than 25% of the volume on the pre-randomisation scan | 1) CT scan done before receipt of trial treatment; (2) CT scan done after receipt of trial treatment (up to 28 days after randomisation) | |
| Other | Frequency of delayed haemorrhage: | 1) CT scan done before receipt of trial treatment; (2) CT scan done after receipt of trial treatment (up to 28 days after randomisation) |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers8
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01402882
GET https://conductscience.org/api/trials/v1/NCT01402882/registered