Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2)

A randomised, placebo-controlled trial

Fatos Olldashi*, Mihal Kerçi, Tefik Zhurda, Klotilda Ruçi, Arben Banushi, Mario Sardón Traverso, Juan Jiménez, Jorge Balbi, Christian Dellera, Silvana Svampa, Gustavo Quintana, Gustavo Piñero, Jorge Teves, Ian Seppelt, David Mountain, John Hunter, Zsolt Balogh, Maniruz Zaman, Patrick Druwé, Robert Rutsaert & 489 others Guy Mazairac, Fogang Pascal, Zognou Yvette, Djeuchon Chancellin, Patrick Okwen, Jules Djokam-Liapoe, Ernest Jangwa, Lawrence Mbuagbaw, Ninying Fointama, Nguemo Pascal, Frank Baillie, Ji Yao Jiang, Guo Yi Gao, Yin Hui Bao, Carlos Morales, Juan Sierra, Santiago Naranjo, Camilo Correa, Carolina Gómez, Jorge Herrera, Liliana Caicedo, Alexei Rojas, Henry Pastas, Hugo Miranda, Alfredo Constaín, Mayla Perdomo, Diego Muñoz, Álvaro Duarte, Edwin Vásquez, Camilo Ortiz, Bernardo Ayala, Hernán Delgado, Gloria Benavides, Lorena Rosero, Jorge Mejía-Mantilla, Ana Varela, Maríaisabel Calle, José Castillo, Alberto García, Juan Ciro, Clara Villa, Roberto Panesso, Luz Flórez, Argemiro Gallego, Fabián Puentes-Manosalva, Leonor Medina, Kelly Márquez, Adalgiza Reyes Romero, Ricardo Hernández, Julio Martínez, Wilson Gualteros, Zulma Urbina, Julio Velandia, Federico Benítez, Adolfo Trochez, Andrés Villarreal, Pamela Pabón, Héctor López, Laureano Quintero, Andrés Rubiano, Juan Tamayo, Marjoris Piñera, Zadis Navarro, Deborah Rondón, Bárbara Bujan, Leonel Palacios, Daymis Martínez, Yalisa Hernández, Yaimara Fernández, Eugenio Casola, Rodolfo Delgado, Carlos Herrera, Migdacelys Arbolaéz, Mario Domínguez, Marcos Iraola, Omar Rojas, Alba Enseñat, Irene Pastrana, Daniel Rodríguez, Sergio Álvarez De La Campa, Thorvald Fortún, Martha Larrea, Lensky Aragón, Aida Madrazo, Petr Svoboda, Mario Izurieta, Alberto Daccach, Mónica Altamirano, Antonio Ortega, Bolívar Cárdenas, Luis González, Marcelo Ochoa, Fernando Ortega, Fausto Quichimbo, Jenny Guiñanzaca, Ines Zavala, Sayra Segura, Johnny Jerez, Daniel Acosta, Fabián Yánez, Rubén Camacho, Hussein Khamis, Hossam Shafei, Ali Kheidr, Hani Nasr, Moetaz Mosaad, Safwat Rizk, Hesham El Sayed, Taha Moati, Emad Hokkam, Mamdouh Amin, Hany Lowis, Medhat Fawzy, Nabil Bedir, Mohamed Aldars, Virginia Rodríguez, Juan Tobar, Jorge Alvarenga, Budu Shalamberidze, Elza Demuria, Nikoloz Rtveliashvili, Gocha Chutkerashvili, David Dotiashvili, Tamar Gogichaishvili, George Ingorokva, David Kazaishvili, Besik Melikidze, Natia Iashvili, Gia Tomadze, Manana Chkhikvadze, Leri Khurtsidze, Zviad Lomidze, Diana Dzagania, Nikoloz Kvachadze, Giorgi Gotsadze, Vakhtang Kaloiani, Nino Kajaia, Jonathan Dakubo, Simon Naaeder, Priscilla Sowah, Adamu Yusuf, Alhaji Ishak, Paul Selasi-Sefenu, Ballu Sibiri, Sampson Sarpong-Peprah, Theodore Boro, Kanjithanda Bopaiah, Kishore Shetty, Raja Subbiah, Lukman Mulla, Anand Doshi, Yashbir Dewan, Sarvpreet Grewal, Pradipta Tripathy, Jacob Mathew, Bharat Gupta, Anil Lal, Majulie Choudhury, Sanjay Gupta, Smita Gupta, Arun Chug, Venkataramana Pamidimukkala, Palaniappan Jagannath, Mohan Maharaj, Ramaraju Vommi, Naresh Gudipati, W. H. Chhang, Pankaj Patel, Nilay Suthar, Deepa Banker, Jyotish Patel, Satish Dharap, Ranjeet Kamble, Shraddha Patkar, Sushil Lohiya, Rakesh Saraf, Dinesh Kumar, Satish Parihar, Rahul Gupta, Rasananda Mangual, Don Kooper, Chinmaya Mohapatra, Suresh David, Wesley Rajaleelan, Ashok Pangi, Vivek Saraf, Santhosh Chikareddy, Sushil Mankar, Anil Golhar, Rahul Sakhare, Nilesh Wagh, Dhiman Hazarika, Pratyush Chaudhuri, Prakash Ketan, Govindbhai Purohit, Yogesh Purohit, Mandakini Pandya, Rakesh Gupta, Shashi Kiran, Saurab Walia, Sonam Goyal, Sidhant Goyal, Satish Goyal, Ashok Attri, Rajeev Sharma, Ashok Oberai, Mahesh Oberai, Supriya Oberoi, Gajendra Kant Tripathi, Vijayan Peettakkandy, Premkumar Karuthillath, Pavithran Vadakammuriyil, Jalindar Pol, Sunita Pol, Manisha Saste, Subrat Raul, Shashi Tiwari, Neileino Nelly, M. Chidambaram, Viswanathan Kollengode, Sam Thampan, Sunder Rajan, Sushrut Rajan, Subodh Raju, Renuka Sharma, Subbiah Venkatesh Babu, Chellappa Sumathi, Protyush Chatterjee, Alok Agarwal, Hemant Magar, Meera Magar, Manmohan Singh, Deepak Gupta, Kamal Haloi, Varsha Sagdeo, Pramod Giri, Nimesh Verma, Ravi Jariwala, Ashish Goti, Aman Prabhu-Gaonkar, Sagar Utagi, Mahesh Joshi, Ruchit Agrawal, Gopal Sharma, Gurvinder Saini, Vinod Tewari, Yad Yadav, Vijay Parihar, Neelam Venkataramana, Shailesh Rao, Narayana Reddy, S. G. Chander, Virsing Hathila, Vithal Das, Kantibhai Agaja, Aniruddh Purohit, Akilesh Lahari, Rajesh Bhagchandani, Bala Vidyasagar, P. K. Sachan, Tanmoy Das, Sharad Vyas, Sujoy Bhattacharjee, Parag Sancheti, T. Manoj, Mubarak Moideen, Kailash Pansey, V. P. Chandrasekaran, Kabul Saikia, Hoshedar Tata, Sanjay Vhora, Aniket Shah, Gordon Rangad, S. Rajasekaran, S. T. Shankarlal, Sathish Devadoss, M. Saleem, Haroon Pillay, Zulfiquer Hazarika, Parikshit Deshmukh, S. P. Murugappan, Amit Jaiswal, Deepak Vangani, Prakash Modha, Chawngrolien Chonzik, Megha Praveen, Vijaya Sethurayar, Sojan Ipe, Naresh Shetty, Vinod Jain, Ketan Shah, Moch Dwikoryanto, Nyoman Golden, Kuning Atmadjaya, Ketut Wiargitha, Ketut Sudiasa, Gede Suwedagatha, Farhad Bal'afif, Vicky Budipramana, Agung Lemuel, Susilo Chandra, Faisol Ama, Ehsan Sherafatkazemzadeh, Ehsan Moradi, Alireza Sheikhi, Ali Ziaee, Ahmad Fanaei, Esmaeil Hajinasrollah, Afshin Amini, Bassim Mohammad, Najah Hadi, Giovanna Perone, Elena De Peri, Annalisa Volpi, Jean Johnson, Masayoshi Abe, Vincent Mutiso, Benjamin Okanga, Daniel Ojuka, Baharudin Abdullah, Hishamuddin Rahman, Yazid Noh, Sabariah Jamaluddin, Hasnah Dawal, April Roslani, Chee Wei Law, P. Devashanti, Yusof Wahab, Shanta Velaiutham, Ridzuan Dato, Jorge Loría, Erandy Montes, Eduardo Gómez, Víctor Cazales, Paúl Bautista, Raúl Bautista, David Ahumada, Edwin Hernández, Germahin Velásquez, Patricia Ortega, Gabriel Lira, Francisco Estrada, Jorge Martínez, Juan Martínez, Oluwole Olaomi, Yari Abubakar, Kanati Apollo, Olawale Badejo, Ogemdi Ihekire, Julio Casasola, Pius Iribhogbe, Olugbenga Oludiran, Emmanuel Obeta, Collins Okojie, Ernest Udefi Agbon, Edward Komolafe, Patrick Olaleye, Tochukwu Uzochukwu, Uvie Onakpoya, Andrew Dongo, Osas Uhunmwagho, Ehi Eighemerio, Eghosa Morgan, Lateef Thanni, Adefemi Afolabi, Titilade Akinola, Adeyinka Ademola, Olusola Akute, Lawal Khalid, Lawal Abubakar, Muhammad Aminu, Mike Ogirima, Ambrose Attansey, Durodola Michael, Olaniran Aremu, Odebode Olugbenga, Udoffa Ukpong, Yusuf Salman, Nene Obianyo, Chinenye Ani, Roderick Ezeadawi, Oluwadiya Kehinde, Agodirin Olaide, Andrea Jogo, Terna Bitto, Stanley Anyanwu, Okechukwu Mbonu, Mobolaji Oludara, Michael Somoye, Bello Shehu, Nasir Ismail, Amechi Katchy, Rowland Ndoma-Egba, Ngim Grace-Inah, Zumnan Songden, Abdulrahman Abdulraheem, Akpan Otu, Timothy Nottidge, Domingo Inyang, David Idiapho, Herb Giebel, Ramatu Hassan, Adeyinka Adisa, Akinbolaji Akinkuolie, Kalu Okam, Abubakar Musa, Ignatius Falope, John Eze, José Caballero, Wenceslao Azabache, Oscar Salirrosas, Alonso Soto, Elfi Torres, Gloria Ramírez, Mónica Pérez, Cesar Malca, Juan Velez, Raul Yepez, Hernan Yupanqui, Pedro Lagos, Diana Rodriguez, Jorge Flores, Anselmo Moya, Alejandro Barrionuevo, Marco Gonzales-Portillo, Edgar Nunez, Abdelazeem Eldawlatly, Mohammed Al Naami, Bilal Delvi, Walid Alyafi, Branko Djurovic, Ivan Ng, Aktham Yaghi, Anton Laincz, Stefan Trenkler, Jozef Valky, Mphako Modiba, Peter Legodi, Thomas Rangaka, Lee Wallis, Ángeles Muñoz, Ana Serrano, Maite Misis, Martin Rubi, Victoria De La Torre, Ranjith Ellawala, Samitha Wijeratna, Lukshrini Gunaratna, Crishantha Wijayanayaka, Kitugi Nungu, Billy Haonga, Grenda Mtapa, Surakrant Yutthakasemsunt, Warawut Kittiwattanagul, Parnumas Piyavechvirat, Tawatcahi Impool, Santipong Thummaraj, Rusta Salaeh, Sakchai Tangchitvittaya, Kamol Wattanakrai, Chatchai Soonthornthum, Teerasak Jiravongbunrod, Surasak Meephant, Pusit Subsompon, Phaiboon Pensuwan, Wicheanrat Chamnongwit, Zouheir Jerbi, Abderraouef Cherif, Mark Nash, Tim Harris, Jay Banerjee, Ramzi Freij, Jason Kendall, Stephen Moore, William Townend, Rowland Cottingham, Dan Becker, Stuart Lloyd, Peter Burdett-Smith, Kazim Mirza, Andrew Webster, Suzanne Brady, Amanda Grocutt, John Thurston, Fiona Lecky, Steve Goodacre, Yakub Mulla, Dennis Sakala, Charles Chengo

*Corresponding author for this work

Research output: Contribution to journalArticle

1648 Citations (Scopus)

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 languageEnglish
Pages (from-to)23-32
Number of pages10
JournalThe Lancet
Volume376
Issue number9734
DOIs
Publication statusPublished - 2010

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