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Clinical Randomisation of an Antifibrinolytic in Significant Haemorrhage

2014-08-27 03:42:35 | BioPortfolio

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).

Description

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Hemorrhage

Intervention

Tranexamic acid, Sodium Chloride 0.9%

Location

Over 50 countries Worldwide
London
United Kingdom

Status

Active, not recruiting

Source

London School of Hygiene and Tropical Medicine

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:42:35-0400

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PubMed Articles [9167 Associated PubMed Articles listed on BioPortfolio]

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Medical and Biotech [MESH] Definitions

Antifibrinolytic hemostatic used in severe hemorrhage.

Bicarbonate transporters that move BICARBONATE IONS in exchange of CHLORIDE IONS or SODIUM IONS across membranes. They regulate acid-base HOMEOSTASIS, cell volume and intracellular pH. Members include CHLORIDE-BICARBONATE ANTIPORTERS (SLC4A1, 2, 3, and 9); SODIUM-COUPLED BICARBONATE TRANSPORTERS (SLC4A4 and 5, 7, 8 and 10); and a sodium borate cotransporter (SLC4A11 protein).

A subclass of symporters that specifically transport SODIUM CHLORIDE and POTASSIUM CHLORIDE across cellular membranes in a tightly coupled process.

Agents that inhibit SODIUM CHLORIDE SYMPORTERS. They act as DIURETICS. Excess use is associated with HYPOKALEMIA.

Sodium chloride used in foods.

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