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Clinical Randomisation of an Antifibrinolytic in Significant Haemorrhage

This study has been completed.
Sponsor:
Information provided by:
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT00375258
First received: September 11, 2006
Last updated: June 29, 2011
Last verified: June 2011

September 11, 2006
June 29, 2011
May 2005
February 2010   (final data collection date for primary outcome measure)
Death in hospital within four weeks of injury (causes of death will be described to assess whether deaths were due to haemorrhage or vascular occlusion). [ Time Frame: Death, discharge or four weeks post randomisation whichever occurs first. ] [ Designated as safety issue: Yes ]
Death in hospital within four weeks of injury
Complete list of historical versions of study NCT00375258 on ClinicalTrials.gov Archive Site
Receipt of a blood products transfusion, the number of units of blood products transfused, surgical intervention, and the occurrence of thrombo-embolic episodes [ Time Frame: Death, discharge or four weeks post randomisation whichever occurs first. ] [ Designated as safety issue: Yes ]
Receipt of a blood products transfusion, the number of units of blood products transfused, surgical intervention, and the occurrence of thrombo-embolic episodes
Not Provided
Not Provided
 
Clinical Randomisation of an Antifibrinolytic in Significant Haemorrhage
A Large Randomised Placebo Controlled Trial Among Trauma Patients With, or at Risk of, Significant Haemorrhage, of the Effects of Antifibrinolytic Treatment on Death and Transfusion Requirement

CRASH 2 is a large pragmatic randomised placebo controlled trial of the effects of the early administration of the antifibrinolytic agent tranexamic acid on death, vascular events and transfusion requirements. Adults with trauma who are within 8 hours of injury and have either significant haemorrhage, or who are considered to be at risk of significant haemorrhage, are eligible if the responsible doctor is for any reason substantially uncertain whether or not to use an antifibrinolytic agent. Numbered drug or placebo packs will be available in each participating emergency department. Randomisation will involve calling a 24-hour freecall randomisation service. The call should last only a minute or two and at the end of it the randomisation service will specify which numbered treatment pack to use. For hospitals where telephone randomisation is not feasible, randomisation will be by taking the next consecutively numbered treatment pack. No extra tests are required but a short form must be completed one month later or on discharge or on death (whichever occurs first).

See trial website for full protocol. This is an international trial with over 300 hospitals in about 40 countries worldwide.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hemorrhage
  • Drug: Tranexamic acid
    Loading dose of 1 gram then 1 gram by infusion over 8 hours
  • Drug: Sodium Chloride 0.9%
    Visual matched placebo
  • Experimental: 1
    Active
    Intervention: Drug: Tranexamic acid
  • Placebo Comparator: 2
    Intervention: Drug: Sodium Chloride 0.9%

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20211
March 2010
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

All trauma patients with ongoing significant haemorrhage (systolic blood pressure less than 90 mmHg and/or heart rate more than 110 beats per minute), or 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. Although entry is allowed up to 8 hours from injury, the earlier that patients can be treated the better.

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

Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00375258
ISRCTN86750102
Yes
Professor Ian Roberts (Chief Investigator), London School of Hygiene and Tropical Medicine
London School of Hygiene and Tropical Medicine
Not Provided
Principal Investigator: Ian Roberts, MD London School of Hygiene and Tropical Medicine
London School of Hygiene and Tropical Medicine
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP