Abstract
Background Tranexamic acid can reduce bleeding in patients undergoing elective surgery. We assessed the effects of early administration of a short course of tranexamic acid on death, vascular occlusive events, and the receipt of blood transfusion in trauma patients. Methods This randomised controlled trial was undertaken in 274 hospitals in 40 countries. 20 211 adult trauma patients with, or at risk of, significant bleeding were randomly assigned within 8 h of injury to either tranexamic acid (loading dose 1 g over 10 min then infusion of 1 g over 8 h) or matching placebo. Randomisation was balanced by centre, with an allocation sequence based on a block size of eight, generated with a computer random number generator. Both participants and study staff (site investigators and trial coordinating centre staff ) were masked to treatment allocation. The primary outcome was death in hospital within 4 weeks of injury, and was described with the following categories: bleeding, vascular occlusion (myocardial infarction, stroke and pulmonary embolism), multiorgan failure, head injury, and other. All analyses were by intention to treat. This study is registered as ISRCTN86750102, Clinicaltrials.gov NCT00375258, and South African Clinical Trial Register DOH-27-0607-1919. Findings 10 096 patients were allocated to tranexamic acid and 10 115 to placebo, of whom 10 060 and 10 067, respectively, were analysed. All-cause mortality was significantly reduced with tranexamic acid (1463 [14·5%] tranexamic acid group vs 1613 [16·0%] placebo group; relative risk 0·91, 95% CI 0·85-0·97; p=0·0035). The risk of death due to bleeding was significantly reduced (489 [4·9%] vs 574 [5·7%]; relative risk 0·85, 95% CI 0·76-0·96; p=0·0077). Interpretation Tranexamic acid safely reduced the risk of death in bleeding trauma patients in this study. On the basis of these results, tranexamic acid should be considered for use in bleeding trauma patients. Funding UK NIHR Health Technology Assessment programme, Pfizer, BUPA Foundation, and J P Moulton Charitable Foundation.
| Original language | English |
|---|---|
| Pages (from-to) | 23-32 |
| Number of pages | 10 |
| Journal | The Lancet |
| Volume | 376 |
| Issue number | 9734 |
| DOIs | |
| Publication status | Published - 2010 |
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In: The Lancet, Vol. 376, No. 9734, 2010, p. 23-32.
Research output: Contribution to journal › Article › peer-review
TY - JOUR
T1 - Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2)
T2 - A randomised, placebo-controlled trial
AU - Olldashi, Fatos
AU - Kerçi, Mihal
AU - Zhurda, Tefik
AU - Ruçi, Klotilda
AU - Banushi, Arben
AU - Traverso, Mario Sardón
AU - Jiménez, Juan
AU - Balbi, Jorge
AU - Dellera, Christian
AU - Svampa, Silvana
AU - Quintana, Gustavo
AU - Piñero, Gustavo
AU - Teves, Jorge
AU - Seppelt, Ian
AU - Mountain, David
AU - Hunter, John
AU - Balogh, Zsolt
AU - Zaman, Maniruz
AU - Druwé, Patrick
AU - Rutsaert, Robert
AU - Mazairac, Guy
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AU - Yvette, Zognou
AU - Chancellin, Djeuchon
AU - Okwen, Patrick
AU - Djokam-Liapoe, Jules
AU - Jangwa, Ernest
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AU - Rosero, Lorena
AU - Mejía-Mantilla, Jorge
AU - Varela, Ana
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AU - Panesso, Roberto
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AU - Márquez, Kelly
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PY - 2010
Y1 - 2010
N2 - Background Tranexamic acid can reduce bleeding in patients undergoing elective surgery. We assessed the effects of early administration of a short course of tranexamic acid on death, vascular occlusive events, and the receipt of blood transfusion in trauma patients. Methods This randomised controlled trial was undertaken in 274 hospitals in 40 countries. 20 211 adult trauma patients with, or at risk of, significant bleeding were randomly assigned within 8 h of injury to either tranexamic acid (loading dose 1 g over 10 min then infusion of 1 g over 8 h) or matching placebo. Randomisation was balanced by centre, with an allocation sequence based on a block size of eight, generated with a computer random number generator. Both participants and study staff (site investigators and trial coordinating centre staff ) were masked to treatment allocation. The primary outcome was death in hospital within 4 weeks of injury, and was described with the following categories: bleeding, vascular occlusion (myocardial infarction, stroke and pulmonary embolism), multiorgan failure, head injury, and other. All analyses were by intention to treat. This study is registered as ISRCTN86750102, Clinicaltrials.gov NCT00375258, and South African Clinical Trial Register DOH-27-0607-1919. Findings 10 096 patients were allocated to tranexamic acid and 10 115 to placebo, of whom 10 060 and 10 067, respectively, were analysed. All-cause mortality was significantly reduced with tranexamic acid (1463 [14·5%] tranexamic acid group vs 1613 [16·0%] placebo group; relative risk 0·91, 95% CI 0·85-0·97; p=0·0035). The risk of death due to bleeding was significantly reduced (489 [4·9%] vs 574 [5·7%]; relative risk 0·85, 95% CI 0·76-0·96; p=0·0077). Interpretation Tranexamic acid safely reduced the risk of death in bleeding trauma patients in this study. On the basis of these results, tranexamic acid should be considered for use in bleeding trauma patients. Funding UK NIHR Health Technology Assessment programme, Pfizer, BUPA Foundation, and J P Moulton Charitable Foundation.
AB - Background Tranexamic acid can reduce bleeding in patients undergoing elective surgery. We assessed the effects of early administration of a short course of tranexamic acid on death, vascular occlusive events, and the receipt of blood transfusion in trauma patients. Methods This randomised controlled trial was undertaken in 274 hospitals in 40 countries. 20 211 adult trauma patients with, or at risk of, significant bleeding were randomly assigned within 8 h of injury to either tranexamic acid (loading dose 1 g over 10 min then infusion of 1 g over 8 h) or matching placebo. Randomisation was balanced by centre, with an allocation sequence based on a block size of eight, generated with a computer random number generator. Both participants and study staff (site investigators and trial coordinating centre staff ) were masked to treatment allocation. The primary outcome was death in hospital within 4 weeks of injury, and was described with the following categories: bleeding, vascular occlusion (myocardial infarction, stroke and pulmonary embolism), multiorgan failure, head injury, and other. All analyses were by intention to treat. This study is registered as ISRCTN86750102, Clinicaltrials.gov NCT00375258, and South African Clinical Trial Register DOH-27-0607-1919. Findings 10 096 patients were allocated to tranexamic acid and 10 115 to placebo, of whom 10 060 and 10 067, respectively, were analysed. All-cause mortality was significantly reduced with tranexamic acid (1463 [14·5%] tranexamic acid group vs 1613 [16·0%] placebo group; relative risk 0·91, 95% CI 0·85-0·97; p=0·0035). The risk of death due to bleeding was significantly reduced (489 [4·9%] vs 574 [5·7%]; relative risk 0·85, 95% CI 0·76-0·96; p=0·0077). Interpretation Tranexamic acid safely reduced the risk of death in bleeding trauma patients in this study. On the basis of these results, tranexamic acid should be considered for use in bleeding trauma patients. Funding UK NIHR Health Technology Assessment programme, Pfizer, BUPA Foundation, and J P Moulton Charitable Foundation.
UR - http://www.scopus.com/inward/record.url?scp=77954717667&partnerID=8YFLogxK
U2 - 10.1016/S0140-6736(10)60835-5
DO - 10.1016/S0140-6736(10)60835-5
M3 - Article
C2 - 20554319
AN - SCOPUS:77954717667
SN - 0140-6736
VL - 376
SP - 23
EP - 32
JO - The Lancet
JF - The Lancet
IS - 9734
ER -