Resumen
Background The aim of the CRASH-2 trial was to assess the effects of early administration of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage. Tranexamic acid significantly reduced all-cause mortality. Because tranexamic acid is thought to exert its effect through inhibition of fibrinolysis, we undertook exploratory analyses of its effect on death due to bleeding. Methods The CRASH-2 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 followed by infusion of 1 g over 8 h) or placebo. Patients were randomly assigned by selection of the lowest numbered treatment pack from a box containing eight numbered packs that were identical apart from the pack number. Both participants and study staff (site investigators and trial coordinating centre staff) were masked to treatment allocation. We examined the effect of tranexamic acid on death due to bleeding according to time to treatment, severity of haemorrhage as assessed by systolic blood pressure, Glasgow coma score (GCS), and type of injury. All analyses were by intention to treat. The trial is registered as ISRCTN86750102, ClinicalTrials.gov NCT00375258, and South African Clinical Trial Register/Department of Health 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. 1063 deaths (35) were due to bleeding. We recorded strong evidence that the effect of tranexamic acid on death due to bleeding varied according to the time from injury to treatment (test for interaction p<0·0001). Early treatment (≤1 h from injury) significantly reduced the risk of death due to bleeding (198/3747 [5·3] events in tranexamic acid group vs 286/3704 [7·7] in placebo group; relative risk [RR] 0·68, 95 CI 0·57-0·82; p<0·0001). Treatment given between 1 and 3 h also reduced the risk of death due to bleeding (147/3037 [4·8] vs 184/2996 [6·1]; RR 0·79, 0·64-0·97; p=0·03). Treatment given after 3 h seemed to increase the risk of death due to bleeding (144/3272 [4·4] vs 103/3362 [3·1]; RR 1·44, 1·12-1·84; p=0·004). We recorded no evidence that the effect of tranexamic acid on death due to bleeding varied by systolic blood pressure, Glasgow coma score, or type of injury. Interpretation Tranexamic acid should be given as early as possible to bleeding trauma patients. For trauma patients admitted late after injury, tranexamic acid is less effective and could be harmful. Funding UK NIHR Health Technology Assessment programme, Pfizer, BUPA Foundation, and J P Moulton Charitable Foundation.
| Idioma original | Inglés |
|---|---|
| Páginas (desde-hasta) | 1096-1101.e2 |
| Publicación | The Lancet |
| Volumen | 377 |
| N.º | 9771 |
| DOI | |
| Estado | Publicada - 2011 |
| Publicado de forma externa | Sí |
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En: The Lancet, Vol. 377, N.º 9771, 2011, p. 1096-1101.e2.
Producción científica: Contribución a una revista › Artículo › revisión exhaustiva
TY - JOUR
T1 - The importance of early treatment with tranexamic acid in bleeding trauma patients
T2 - An exploratory analysis of the CRASH-2 randomised 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 - Balogh, Zsolt
AU - Zaman, Maniruz
AU - Druwé, Patrick
AU - Rutsaert, Robert
AU - Mazairac, Guy
AU - Pascal, Fogang
AU - Yvette, Zognou
AU - Chancellin, Djeuchon
AU - Okwen, Patrick
AU - Djokam-Liapoe, Jules
AU - Jangwa, Ernest
AU - Mbuagbaw, Lawrence
AU - Fointama, Ninying
AU - Baillie, Frank
AU - Jiang, Ji Yao
AU - Gao, Guo Yi
AU - Bao, Yin Hui
AU - Morales, Carlos
AU - Sierra, Juan
AU - Naranjo, Santiago
AU - Correa, Camilo
AU - Gómez, Carolina
AU - Herrera, Jorge
AU - Caicedo, Liliana
AU - Rojas, Alexei
AU - Pastas, Henry
AU - Miranda, Hugo
AU - Constaín, Alfredo
AU - Perdomo, Mayla
AU - Muñoz, Diego
AU - Duarte, Álvaro
AU - Vásquez, Edwin
AU - Ortiz, Camilo
AU - Ayala, Bernardo
AU - Delgado, Hernán
AU - Benavides, Gloria
AU - Rosero, Lorena
AU - Mejía-Mantilla, Jorge
AU - Varela, Ana
AU - Calle, Maríaisabel
AU - Castillo, José
AU - García, Alberto
AU - Ciro, Juan
AU - Villa, Clara
AU - Panesso, Roberto
AU - Flórez, Luz
AU - Gallego, Argemiro
AU - Puentes-Manosalva, Fabián
AU - Medina, Leonor
AU - Márquez, Kelly
AU - Romero, Adalgiza Reyes
AU - Hernández, Ricardo
AU - Martínez, Julio
AU - Gualteros, Wilson
AU - Urbina, Zulma
AU - Velandia, Julio
AU - Benítez, Federico
AU - Trochez, Adolfo
AU - Villarreal, Andrés
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AU - López, Héctor
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AU - Tamayo, Juan
AU - Piñera, Marjoris
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AU - Martínez, Heriberto
AU - Casola, Eugenio
AU - Domínguez, Mario
AU - Herrera, Carlos
AU - Iraola, Marcos
AU - Rojas, Omar
AU - Pastrana, Irene
AU - Rodríguez, Daniel
AU - De La Campa, Sergio Álvarez
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AU - Svoboda, Petr
AU - Izurieta, Mario
AU - Daccach, Alberto
AU - Altamirano, Mónica
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AU - Cárdenas, Bolívar
AU - González, Luis
AU - Ochoa, Marcelo
AU - Ortega, Fernando
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AU - Segura, Sayra
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AU - Gupta, Smita
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AU - Tiwari, Shashi
AU - Nelly, Neileino
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AU - Rajan, Sunder
AU - Rajan, Sushrut
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AU - Sharma, Renuka
AU - Babu, Subbiah Venkatesh
AU - Sumathi, Chellappa
AU - Chatterjee, Protyush
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AU - Magar, Hemant
AU - Magar, Meera
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AU - Gupta, Deepak
AU - Haloi, Kamal
AU - Sagdeo, Varsha
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AU - Budipramana, Vicky
AU - Tabrani,
AU - Lemuel, Agung
AU - Chandra, Susilo
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AU - Ojuka, Daniel
AU - Abdullah, Baharudin
AU - Rahman, Hishamuddin
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AU - Estrada, Francisco
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AU - Martínez, Juan
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AU - Badejo, Olawale
AU - Ihekire, Ogemdi
AU - Iribhogbe, Pius
AU - Oludiran, Olugbenga
AU - Obeta, Emmanuel
AU - Okojie, Collins
AU - Udefiagbon, Ernest
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AU - Olaleye, Patrick
AU - Uzochukwu, Tochukwu
AU - Onakpoya, Uvie
AU - Dongo, Andrew
AU - Thanni, Lateef
AU - Afolabi, Adefemi
AU - Akinola, Titilade
AU - Ademola, Adeyinka
AU - Akute, Olusola
AU - Khalid, Lawal
AU - Abubakar, Lawal
AU - Aminu, Muhammad
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AU - Attansey, Ambrose
AU - Michael, Durodola
AU - Aremu, Olaniran
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AU - Salman, Yusuf
AU - Obianyo, Nene
AU - Ani, Chinenye
AU - Ezeadawi, Roderick
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AU - Jogo, Andrea
AU - Bitto, Terna
AU - Anyanwu, Stanley
AU - Mbonu, Okechukwu
AU - Oludara, Mobolaji
AU - Somoye, Michael
AU - Shehu, Bello
AU - Ismail, Nasir
AU - Katchy, Amechi
AU - Ndoma-Egba, Rowland
AU - Grace-Inah, Ngim
AU - Songden, Zumnan
AU - Abdulraheem, Abdulrahman
AU - Otu, Akpan
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AU - Inyang, Domingo
AU - Idiapho, David
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AU - Hassan, Ramatu
AU - Adisa, Adeyinka
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AU - Chamnongwit, Wicheanrat
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AU - Nash, Mark
AU - Harris, Tim
AU - Banerjee, Jay
AU - Freij, Ramzi
AU - Kendall, Jason
AU - Moore, Stephen
AU - Townend, William
AU - Cottingham, Rowland
AU - Becker, Dan
AU - Lloyd, Stuart
AU - Burdett-Smith, Peter
AU - Mirza, Kazim
AU - Webster, Andrew
AU - Brady, Suzanne
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AU - Lecky, Fiona
AU - Goodacre, Steve
AU - Mulla, Yakub
AU - Sakala, Dennis
AU - Chengo, Charles
PY - 2011
Y1 - 2011
N2 - Background The aim of the CRASH-2 trial was to assess the effects of early administration of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage. Tranexamic acid significantly reduced all-cause mortality. Because tranexamic acid is thought to exert its effect through inhibition of fibrinolysis, we undertook exploratory analyses of its effect on death due to bleeding. Methods The CRASH-2 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 followed by infusion of 1 g over 8 h) or placebo. Patients were randomly assigned by selection of the lowest numbered treatment pack from a box containing eight numbered packs that were identical apart from the pack number. Both participants and study staff (site investigators and trial coordinating centre staff) were masked to treatment allocation. We examined the effect of tranexamic acid on death due to bleeding according to time to treatment, severity of haemorrhage as assessed by systolic blood pressure, Glasgow coma score (GCS), and type of injury. All analyses were by intention to treat. The trial is registered as ISRCTN86750102, ClinicalTrials.gov NCT00375258, and South African Clinical Trial Register/Department of Health 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. 1063 deaths (35) were due to bleeding. We recorded strong evidence that the effect of tranexamic acid on death due to bleeding varied according to the time from injury to treatment (test for interaction p<0·0001). Early treatment (≤1 h from injury) significantly reduced the risk of death due to bleeding (198/3747 [5·3] events in tranexamic acid group vs 286/3704 [7·7] in placebo group; relative risk [RR] 0·68, 95 CI 0·57-0·82; p<0·0001). Treatment given between 1 and 3 h also reduced the risk of death due to bleeding (147/3037 [4·8] vs 184/2996 [6·1]; RR 0·79, 0·64-0·97; p=0·03). Treatment given after 3 h seemed to increase the risk of death due to bleeding (144/3272 [4·4] vs 103/3362 [3·1]; RR 1·44, 1·12-1·84; p=0·004). We recorded no evidence that the effect of tranexamic acid on death due to bleeding varied by systolic blood pressure, Glasgow coma score, or type of injury. Interpretation Tranexamic acid should be given as early as possible to bleeding trauma patients. For trauma patients admitted late after injury, tranexamic acid is less effective and could be harmful. Funding UK NIHR Health Technology Assessment programme, Pfizer, BUPA Foundation, and J P Moulton Charitable Foundation.
AB - Background The aim of the CRASH-2 trial was to assess the effects of early administration of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage. Tranexamic acid significantly reduced all-cause mortality. Because tranexamic acid is thought to exert its effect through inhibition of fibrinolysis, we undertook exploratory analyses of its effect on death due to bleeding. Methods The CRASH-2 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 followed by infusion of 1 g over 8 h) or placebo. Patients were randomly assigned by selection of the lowest numbered treatment pack from a box containing eight numbered packs that were identical apart from the pack number. Both participants and study staff (site investigators and trial coordinating centre staff) were masked to treatment allocation. We examined the effect of tranexamic acid on death due to bleeding according to time to treatment, severity of haemorrhage as assessed by systolic blood pressure, Glasgow coma score (GCS), and type of injury. All analyses were by intention to treat. The trial is registered as ISRCTN86750102, ClinicalTrials.gov NCT00375258, and South African Clinical Trial Register/Department of Health 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. 1063 deaths (35) were due to bleeding. We recorded strong evidence that the effect of tranexamic acid on death due to bleeding varied according to the time from injury to treatment (test for interaction p<0·0001). Early treatment (≤1 h from injury) significantly reduced the risk of death due to bleeding (198/3747 [5·3] events in tranexamic acid group vs 286/3704 [7·7] in placebo group; relative risk [RR] 0·68, 95 CI 0·57-0·82; p<0·0001). Treatment given between 1 and 3 h also reduced the risk of death due to bleeding (147/3037 [4·8] vs 184/2996 [6·1]; RR 0·79, 0·64-0·97; p=0·03). Treatment given after 3 h seemed to increase the risk of death due to bleeding (144/3272 [4·4] vs 103/3362 [3·1]; RR 1·44, 1·12-1·84; p=0·004). We recorded no evidence that the effect of tranexamic acid on death due to bleeding varied by systolic blood pressure, Glasgow coma score, or type of injury. Interpretation Tranexamic acid should be given as early as possible to bleeding trauma patients. For trauma patients admitted late after injury, tranexamic acid is less effective and could be harmful. Funding UK NIHR Health Technology Assessment programme, Pfizer, BUPA Foundation, and J P Moulton Charitable Foundation.
UR - https://www.scopus.com/pages/publications/79953163189
U2 - 10.1016/S0140-6736(11)60278-X
DO - 10.1016/S0140-6736(11)60278-X
M3 - Artículo
C2 - 21439633
AN - SCOPUS:79953163189
SN - 0140-6736
VL - 377
SP - 1096-1101.e2
JO - The Lancet
JF - The Lancet
IS - 9771
ER -