Tranexamic Acid for the treatment of significant traumatic head injury - CRASH-3

• Register: EUCTR
• Last refreshed on: 30 April 2019
• Main ID: EUCTR2011-003669-14-ES
• Date of registration: 12/06/2012
• Prospective Registration: Yes
• Primary sponsor: London School Of Hygiene and Tropical Medicine
• Public title: Tranexamic Acid for the treatment of significant traumatic head injury - CRASH-3
• Scientific title: Tranexamic Acid for the treatment of significant traumatic brain injury: an international, randomised, double blind, placebo controlled trial. - CRASH-3 [Version 1.0]
• Date of first enrolment: 03/12/2012
• Target sample size: 10000
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-003669-14
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Albania, Argentina, Bangladesh, Cameroon, Colombia, Ecuador, Egypt, El Salvador, Georgia, Ghana, India, Indonesia, Ireland, Italy, Jamaica, Kenya, Mexico, Nigeria, Pakistan, Slovenia, Spain, Sudan, Thailand, Tunisia, Uganda, Ukraine, United Kingdom

Contacts

• Name: Haleema Shakur
• Affiliation: London School Of Hygiene and Tropical Medicine

• Name: Haleema Shakur
• Affiliation: London School Of Hygiene and Tropical Medicine

Key inclusion & exclusion criteria

Inclusion criteria:
Adult (16 years and older) with traumatic brain injury (TBI)
? who are within 8 hours of injury
? with any intracranial bleeding on CT scan OR GCS ?12 if no scan available, and
? who have no significant extra cranial bleeding (needing immediate blood transfusion)
? The fundamental eligibility criterion is the responsible clinician?s ?uncertainty? as to whether or not to use tranexamic acid in a particular patient with TBI
Are the trial subjects under 18? yes
Number of subjects for this age range: 1000
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1000

Exclusion criteria:
? Patients should not be randomised if the responsible clinician considers there is a clear indication for antifibrinolytic therapy
? Patients should not be randomised if the responsible clinician considers there is a clear contraindication for antifibrinolytic therapy


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]

Traumatic Brain Injury
MedDRA version: 14.1 Level: LLT Classification code 10060690 Term: Traumatic brain injury System Organ Class: 10022117 - Injury, poisoning and procedural complications

Intervention(s)

Trade Name: Cyklokapron
Product Name: Cyklokapron
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Tranexamic Acid
CAS Number: 1197-18-8
Current Sponsor code: ISRCTN15088122
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Main Objective: The CRASH-3 trial will see if a drug called tranexamic acid will improve outcomes for people who have suffered a traumatic head injury. The main outcome is its effect on death within 28 days of the head injury. We will also assess the cause of death.

Secondary Objective: The secondary objectives will be to assess whether using tranexamic acid leads to better outcomes such as reduced disability, fewer days in intensive care, and fewer surgical interventions. In addition, we will assess whether there is any increase in serious outcomes including heart attack, stroke and blood clots in the legs or lungs, and seizures.

Primary end point(s): The primary outcome measure is death in hospital within 28 days of injury. Cause-specific mortality will also be recorded.

Timepoint(s) of evaluation of this end point: 28 days after randomisation or at death or hospital discharge if either happens sooner

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 28 days after randomisation or at death or hospital discharge if either happens sooner

Secondary end point(s): (a)Vascular occlusive events (myocardial infarction, pulmonary embolism, clinical evidence of deep vein thrombosis)
(b)Stroke
(c)Disability assessed using the Disability Rating Scale and Patient Orientated Outcome measures
(d)Seizures
(e)Neurosurgical intervention
(f)Days in intensive care
(g)Other adverse events

Secondary ID(s)

NCT01402882

ISRCTN15088122

Source(s) of Monetary Support

JP Moulton Charitable Foundation

Ethics review

Status: Approved
Approval date:
Contact: