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Clinical Randomisation of an Antifibrinolytic in Significant Head Injury (CRASH-3)

This study is currently recruiting participants.
Verified September 2016 by London School of Hygiene and Tropical Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT01402882
First Posted: July 26, 2011
Last Update Posted: December 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine
  Purpose
The CRASH-3 trial will provide reliable evidence about the effect of tranexamic acid on mortality and disability in patients with traumatic brain injury. The effect of tranexamic acid on the risk of vascular occlusive events and seizures will also be assessed. Additionally, a nested study will be conducted in a subset of CRASH-3 trial participants. This nested study (CRASH-3 Intracranial Bleeding Sub-Study [CRASH-3 IBS]) will examine the effect of tranexamic acid on intracranial haemorrhage and cerebral ischaemia using CT Scans in approximately 1,000 patients randomised into the CRASH-3 trial.

Condition Intervention Phase
Traumatic Brain Injury Drug: Tranexamic Acid Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tranexamic Acid for the Treatment of Significant Traumatic Brain Injury: an International Randomised, Double Blind Placebo Controlled Trial

Resource links provided by NLM:


Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • The primary outcome is death in hospital in patients recruited within 3 hours and cause of death will be described. [ Time Frame: within 28 days of injury ]

Secondary Outcome Measures:
  • (a) Vascular occlusive events (myocardial infarction, stroke, pulmonary embolism, clinical evidence of deep vein thrombosis) [ Time Frame: Prior death, discharge or 28 days ]
  • (b) In hospital disability assessed using the Disability Rating Scale and Patient Orientated Outcome [ Time Frame: Prior death, discharge or 28 days ]
  • (c) Seizures [ Time Frame: Prior death, discharge or day 28 ]
  • (d) Neurosurgical intervention [ Time Frame: prior death, discharge or day 28 ]
  • (e) Days in intensive care [ Time Frame: prior death, discharge or day 28 ]
  • (f) Other adverse events [ Time Frame: prior death, discharge or day 28 ]

Other Outcome Measures:
  • CRASH-3 IBS: Primary outcome - the total volume of intracranial haemorrhage [ Time Frame: 1) CT scan done before receipt of trial treatment; (2) CT scan done after receipt of trial treatment (up to 28 days after randomisation) ]
  • 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 [ Time Frame: 1) CT scan done before receipt of trial treatment; (2) CT scan done after receipt of trial treatment (up to 28 days after randomisation) ]
  • Frequency of delayed haemorrhage: [ Time Frame: 1) CT scan done before receipt of trial treatment; (2) CT scan done after receipt of trial treatment (up to 28 days after randomisation) ]
  • New focal ischaemic lesions: [ Time Frame: 1) CT scan done before receipt of trial treatment; (2) CT scan done after receipt of trial treatment (up to 28 days after randomisation) ]
  • • Total volume of intracranial bleeding in patients who undergo surgical evacuation of haemorrhage after randomisation [ Time Frame: 1) CT scan done before receipt of trial treatment; (2) CT scan done after receipt of trial treatment (up to 28 days after randomisation) ]

Estimated Enrollment: 13000
Study Start Date: September 2011
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tranexamic acid Drug: Tranexamic Acid
2 grams (1 gram over 10 minutes and 1 gram over 8 hours)
Placebo Comparator: Placebo
(Sodium Chloride 0.9%)
Drug: Tranexamic Acid
2 grams (1 gram over 10 minutes and 1 gram over 8 hours)

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Adults with traumatic brain injury who

  • are within eight hours of injury (limited to within 3 hours from September, 2016)
  • with any intracranial bleeding on CT scan or who have a GCS of 12 or less, and
  • have no significant extra-cranial haemorrhage The fundamental eligibility criterion is the responsible clinician's 'uncertainty' as to whether or not to use tranexamic acid in a particular patient with traumatic brain injury

Exclusion Criteria:

The fundamental eligibility criterion is the responsible clinician's 'uncertainty' as to whether or not to use tranexamic acid in a particular patient with traumatic brain injury

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01402882


Contacts
Contact: Haleema Shakur, BSc, MSc, RGN ++44(0)20 7958 8113 haleema.shakur@lshtm.ac.uk

Locations
Georgia
High Technology Medical Center, University Clinic Recruiting
Tblisi, Georgia
Contact: Tamar Gogichaishvili         
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Investigators
Study Director: Haleema Shakur LSHTM
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT01402882     History of Changes
Other Study ID Numbers: ISRCTN15088122
First Submitted: July 25, 2011
First Posted: July 26, 2011
Last Update Posted: December 20, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After all relevant publications are completed, totally anonymised data will be available at https://ctu-app.lshtm.ac.uk/freebird/

Keywords provided by London School of Hygiene and Tropical Medicine:
traumatic brain injury
tranexamic acid
antifibrinolytic
randomised
clinical trial

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants