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

Conditions

Traumatic Brain Injury Injury, Occupational Diseases, Poisoning Intracranial injury, unspecified

Ian Roberts, Haleema Shakur‐Still, A Aeron-Thomas, Danielle Beaumont, Antonio Belli et al. (20 authors)

Health Technology Assessment2021-04-0142 citations

Effect of early tranexamic acid treatment on fatigue in patients with mild traumatic brain injury: data from the CRASH-3 clinical trial.

Mansukhani R, Belli A, Brenner A, Chaudhri R, Frimley L, Faizah Jamaluddin S, Jooma R, Shakur-Still H, Shokunbi T, Roberts I.

2021-01-011 citations

10.12688/wellcomeopenres.17421.3

Effect of tranexamic acid on intracranial haemorrhage and infarction in patients with traumatic brain injury: a pre-planned substudy in a sample of CRASH-3 trial patients

Abda Mahmood, Kelly Needham, Haleema Shakur‐Still, Tim Harris, Sabariah Faizah Jamaluddin et al. (18 authors)

Emergency Medicine Journal2020-12-0126 citations

10.1136/emermed-2020-210424

Understanding the neuroprotective effect of tranexamic acid: an exploratory analysis of the CRASH-3 randomised trial.

Brenner A, Belli A, Chaudhri R, Coats T, Frimley L, Jamaluddin SF, Jooma R, Mansukhani R, Sandercock P, Shakur-Still H, Shokunbi T, Roberts I, CRASH-3 trial collaborators.

2020-11-1130 citations

10.1186/s13054-020-03243-4

Effects of tranexamic acid on death, disability, vascular occlusive events and other morbidities in patients with acute traumatic brain injury (CRASH-3): a randomised, placebo-controlled trial.

CRASH-3 trial collaborators.

2019-10-14523 citations

10.1016/s0140-6736(19)32233-0

Tranexamic acid for significant traumatic brain injury (The CRASH-3 trial): Statistical analysis plan for an international, randomised, double-blind, placebo-controlled trial.

Roberts I, Belli A, Brenner A, Chaudhri R, Fawole B, Harris T, Jooma R, Mahmood A, Shokunbi T, Shakur H, CRASH-3 trial collaborators.

2018-09-2625 citations

10.12688/wellcomeopenres.14700.2

A nested mechanistic sub-study into the effect of tranexamic acid versus placebo on intracranial haemorrhage and cerebral ischaemia in isolated traumatic brain injury: study protocol for a randomised controlled trial (CRASH-3 Trial Intracranial Bleeding Mechanistic Sub-Study [CRASH-3 IBMS]).

Mahmood A, Roberts I, Shakur H.

2017-07-1717 citations

10.1186/s13063-017-2073-6

CRASH-3 - tranexamic acid for the treatment of significant traumatic brain injury: study protocol for an international randomized, double-blind, placebo-controlled trial.

Dewan Y, Komolafe EO, Mejía-Mantilla JH, Perel P, Roberts I, Shakur H, CRASH-3 Collaborators.

2012-06-21121 citations

10.1186/1745-6215-13-87

Interventions

1. Tranexamic acid versus placebo 2. Patients will be randomised to either tranexamic acid (loading dose 1 gram over 10 minutes then infusion of 1 gram over 8 hours) or matching placebo Added 20/12/2

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult 2. Traumatic brain injury 3. Within 8 hours of injury (Added 22/01/18: limited to within 3 hours from September 2016) 4. Any intracranial bleeding on CT scan OR a GCS of 12 or less 5. No significant extra-cranial haemorrhage 6. Where the responsible clinician is substantially uncertain as to the appropriateness of antifibrinolytic agents in the patient

Exclusion criteria

Exclusion criteria: The fundamental eligibility criterion is the responsible clinician's 'uncertainty' as to whether or not to use an antifibrinolytic agent in a particular patient with traumatic brain injury

Design outcomes

Primary

Measure	Time frame
Death in hospital within 28 days of injury (Added 22/01/2018: among patients randomised within 3 hours of injury) (cause of death will be described) Added 20/12/2016: CRASH-3 IBS primary outcome: The primary outcome is the total volume of intracranial haemorrhage after randomisation, adjusting for the baseline volume of haemorrhage.	—

Secondary

Measure	Time frame
1. Vascular occlusive events (myocardial infarction, stroke, pulmonary embolism, clinical evidence of deep vein thrombosis) 2. Disability assessed using the Disability Rating Scale and Patient Orientated Outcomes 3. Seizures 4. Neurosurgical intervention 5. Days in intensive care 6. Other adverse events will be described Added 20/12/2016: CRASH-3 IBS secondary outcome: Secondary outcomes will include: frequency of progressive haemorrhage (number of patients with a post-randomisation CT scan with total haemorrhage volume of more than 25% of the volume of the pre-randomisation scan); frequency of delayed haemorrhage (number of patients with haemorrhage on the post-randomisation CT scan when there was not one on the pre-randomisation scan); new focal ischaemic lesions (ischaemic lesions which appear on the post-randomisation CT scan but not on the pre-randomisation scan); total volume of intracranial bleeding after randomisation in patients who undergo surgical evacuation of haemorrhage, adjusting for volume of baseline bleeding.	—

Measure

Time frame

1. Vascular occlusive events (myocardial infarction, stroke, pulmonary embolism, clinical evidence of deep vein thrombosis) 2. Disability assessed using the Disability Rating Scale and Patient Orientated Outcomes 3. Seizures 4. Neurosurgical intervention 5. Days in intensive care 6. Other adverse events will be described Added 20/12/2016: CRASH-3 IBS secondary outcome: Secondary outcomes will include: frequency of progressive haemorrhage (number of patients with a post-randomisation CT scan with total haemorrhage volume of more than 25% of the volume of the pre-randomisation scan); frequency of delayed haemorrhage (number of patients with haemorrhage on the post-randomisation CT scan when there was not one on the pre-randomisation scan); new focal ischaemic lesions (ischaemic lesions which appear on the post-randomisation CT scan but not on the pre-randomisation scan); total volume of intracranial bleeding after randomisation in patients who undergo surgical evacuation of haemorrhage, adjusting for volume of baseline bleeding.

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Countries

Afghanistan, Albania, Cambodia, Cameroon, Canada, Colombia, Egypt, El Salvador, England, Georgia, Indonesia, Iraq, Ireland, Italy, Jamaica, Kenya, Malaysia, Mexico, Myanmar, Nepal, Nigeria, Pakistan, Papua New Guinea, Romania, Spain, United Arab Emirates, United Kingdom, Zambia

Outcome results

None listed