EBQ:CRASH-2 Trial: Difference between revisions
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==Funding== | ==Funding== | ||
UK NIHR Health Technology Assessment programme, Pfizer, BUPA Foundation, and J P Moulton Charitable Foundation | |||
==Sources== | ==Sources== | ||
Revision as of 23:32, 16 February 2014
PubMed Full text PDF
Clinical Question
Does administration of tranexamic acid reduce the risk of death if administered early in severe trauma?
Conclusion
Tranexamic acid improves survival when administered in less than 3 hrs after injury in patients with significant hemorrhage.
Major Points
Tranexamic acid is a synthetic derivative of the aminoacid lysine that inhibits fibrinolysis by blocking the lysine binding sites on plasminogen.[1] Prior systemic review showed a third decrease in blood transfusions but no mortality benefit.[2] In this study, however, the The risk of death due to bleeding was significantly reduced (489 [4·9%] vs 574 [5·7%] as well as all-cause mortality (1463 [14·5%] tranexamic acid group vs 1613 [16·0%] placebo group).
Study Design
- Multicenter, randomized, placebo-controlled trial
Inclusion Criteria
- Adult trauma patients with significant hemorrhage defined as:
- systolic blood pressure <90 mm Hg
- heart rate >110 beats per min
- or both of the above
- or
- Trauma patients considered to be at risk for significant hemorrhage and within 8 h of injury
Exclusion Criteria
- Clear contraindication to tranexamic acid
Interventions
- Loading dose of 1 g of tranexamic acid infused over 10 min, followed by an intravenous infusion of 1 g over 8 h, or placebo (0·9% saline).
Outcome
Primary Outcomes
- Primary outcome was death in hospital within 4 weeks of injury
Secondary Outcomes
Secondary outcomes were:
- Vascular occlusive events
- myocardial infarction
- stroke
- pulmonary embolism
- deep vein thrombosis
- surgical intervention
- neurosurgery
- thoracic
- abdominal
- pelvic surgery
- receipt of blood transfusion, and units of blood products transfused.
Subgroup analysis
Criticisms & Further Discussion
- In 2012 the MATTERS Trial demonstrated the benefits of TXA in military trauma, particularly massive transfusion outcomes.[3]
- Significant criticism exists regarding the randomization scheme where doctors could choose to randomize or not randomize based on treatment certainty. Also only approximately 5% of patients had bleeding as a cause of death and the was no data regarding the severity of hemorrhagic shock. There was also no decrease in blood transfusions and the majority of he population in the study had traumatic brain injury.[4]
Funding
UK NIHR Health Technology Assessment programme, Pfizer, BUPA Foundation, and J P Moulton Charitable Foundation
Sources
- ↑ Okamoto S, Hijikata-Okunomiya A, Wanaka K, Okada Y,Okamoto U. Enzyme controlling medicines: introduction. Semin Thromb Hemost1997;23: 493–501
- ↑ Henry DA, Carless PA, Moxey AJ, et al. Anti-fi brinolytic use for minimising perioperative allogeneic blood transfusion. Cochrane Database Syst Rev 2007; 4: CD001886.
- ↑ Morrison JJ, et al. "Military Application of Tranexamic Acid in Trauma Emergency Resuscitation (MATTERs) Study." Arch Surg. 2012;147(2):113-9.
- ↑ Napolitano LM, Cohen MJ, Cotton BA, Schreiber MA, Moore EE. Tranexamic acid in trauma: how should we use it? JTrauma Acute Care Surg. 2013; 74:1575-1586.