EBQ:CRASH-2 Trial: Difference between revisions
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==Major Points== | ==Major Points== | ||
Tranexamic acid is a synthetic derivative of the aminoacid lysine that inhibits fibrinolysis by blocking the lysine binding sites on plasminogen<ref> Okamoto S, Hijikata-Okunomiya A, Wanaka K, Okada Y,Okamoto U. Enzyme controlling medicines: introduction. | |||
Semin Thromb Hemost1997;23: 493–501</ref>. Prior systemic review showed a third decrease in blood transfusions but no mortality benefit.<ref>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.</ref>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== | ==Study Design== | ||
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==Inclusion Criteria== | ==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== | ==Exclusion Criteria== | ||
#Clear contraindication to tranexamic acid | |||
==Interventions== | ==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== | ==Outcome== | ||
===Primary Outcomes=== | ===Primary Outcomes=== | ||
*Primary outcome was death in hospital within 4 weeks of injury | |||
===Secondary Outcomes=== | ===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=== | ===Subgroup analysis=== | ||
Revision as of 22:22, 16 February 2014
Under Review Journal Club Article
Shakur H, et al. "Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage". The Lancet. 2010. 376(9734):23-32.
PubMed Full text PDF
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
Funding
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.