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Clinical Randomisation of an Antifibrinolytic in Significant Haemorrhage

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ClinicalTrials.gov Identifier: NCT00375258
Recruitment Status : Completed
First Posted : September 12, 2006
Last Update Posted : June 30, 2011
Sponsor:
Information provided by:
London School of Hygiene and Tropical Medicine

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Hemorrhage Drug: Tranexamic acid Drug: Sodium Chloride 0.9% Phase 3

Detailed Description:
See trial website for full protocol. This is an international trial with over 300 hospitals in about 40 countries worldwide.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20211 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2005
Actual Primary Completion Date : February 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Active
 Drug: Tranexamic acid
Loading dose of 1 gram then 1 gram by infusion over 8 hours
Placebo Comparator: 2 Drug: Sodium Chloride 0.9%
Visual matched placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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. ]

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

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

Contacts and Locations
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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): NCT00375258


Locations
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United Kingdom
Over 50 countries Worldwide
London, United Kingdom
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Investigators
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Principal Investigator: Ian Roberts, MD London School of Hygiene and Tropical Medicine
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Professor Ian Roberts (Chief Investigator), London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00375258    
Other Study ID Numbers: ISRCTN86750102
First Posted: September 12, 2006    Key Record Dates
Last Update Posted: June 30, 2011
Last Verified: June 2011
Keywords provided by London School of Hygiene and Tropical Medicine:
Adult trauma patients with ongoing significant haemorrhage or at risk of significant haemorrhage
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
 Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants