NCT00375258

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20,211 (actual)
• Sponsor: London School of Hygiene and Tropical Medicine · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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

Conditions

• Hemorrhage

Interventions

Type	Name	Description
DRUG	Tranexamic acid	Loading dose of 1 gram then 1 gram by infusion over 8 hours
DRUG	Sodium Chloride 0.9%	Visual matched placebo

Timeline

• Start date: 2005-05-01
• Primary completion: 2010-02-01
• Completion: 2010-03-01
• First posted: 2006-09-12
• Last updated: 2011-06-30

Locations

1 site across 1 country: United Kingdom