Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial

作者：Ian Roberts, Haleema Shakur‐Still, Adefemi Oladiran Afolabi, Adegboyega Akere, Mònica Arribas, Amy Charlotte Brenner, Rizwana Chaudhri, Ian T Gilmore, Kenneth Halligan, Irshad Hussain, Vipul Jairath, Kiran Javaid, Aasia Kayani, Ton Lisman, Raoul Mansukhani, Muttiullah Mutti, Muhammad Arif Nadeem, Richard Pollok, Jonathan D. Simmons, Majid Ali Soomro, Simon J. Stanworth, Andrew Veitch, Christopher J. Hawkey, Adefemi Oladiran Afolabi, Jack M. Cuzick, Kenneth Halligan, David A Henry, Chris D. Metcalfe, Ian Roberts, Richard G. Gray, Alan N. Barkun, Suresh S. David, Philip James Devereaux, Tony Brady, Ian Roberts, Haleema Shakur‐Still, Tim Coats, Phil J Edwards, Ian T Gilmore, Vipul Jairath, Katharine Ker, Daniela Manno, Simon J. Stanworth, Andrew Veitch, Mònica Arribas, Emma Austin, Kiran K. Bal, Eni Balogun, Collette Barrow, Danielle Beaumont, Myriam Benyahia, Amy Charlotte Brenner, Imogen Brooks, Madeleine Cargill, Laura Carrington, Phil J Edwards, Lauren Frimley, Amber Geer, Daniel Gilbert, Catherine Gilliam, Julio Gil Onandia, Nayia Golfi, Daniel Hetherington, Courtenay Howe, Carolyn Hughes, David I'Anson, Rob Jackson, Miland Joshi, Sneha Kansagra, Taemi Kawahara, Katharine Ker, Sergey Kostrov, Daniela Manno, Raoul Mansukhani, Hakim Miah, Bernard Ndungu, Kelly Needham, Aroudra Outtandy, Daniel Pearson, Tracey Pepple, Danielle Prowse, Nigel Quashi, Anna Quinn, Maria Fernandez Ramos, Laura Ranopa, Mia Reid, Ian Roberts, Chris Roukas, Haleema Shakur‐Still, Chelci Squires, Jemma Tanner, Andrew Thayne, Ruhama Uddin, Rizwana Chaudhri, Muttiullah Mutti, Kiran Javaid, Aasia Kayani, Bukola Fawole, Folasade Adenike Bello, Oladapo Olayemi, Adefemi Oladiran Afolabi, Olujide Okunade, Olusade Adetayo, Rizwana Chaudhri, Muttiullah Mutti, Adefemi Oladiran Afolabi, Folasade Adenike Bello, Bukola Fawole, Oladapo Olayemi, Hussein Khamis, Mohammad Shukri Jahit, Tamar Gogichaishvili, Radu Bogdan Mateescu, Ajay Adhikaree, Abdelmounem Eltayeib Abdo, Mohammad Abduz Zaher, Conor Deasy, Joaquín Álvarez Gregori, Bobby Wellsh, Luke Lawton, Raghavendra Kamath, Adrian Barry, Racquel Carpio, Kay Finney, Holly Maguire, Martin A. James, Frank Coffey, Chris Gough, Lisa Sawers, Aye-Aye Thi, Jonathan D. Simmons, Claire Burnett, Nicola Jacques, Victoria Murray, Richard Pollok, Heather Jarman, Christine Lambe, Sarah Rounding, Simon C Tucker, Romaih Al-Idari, Samuel I. Guest, Emma Stoddard, D. Yeo, Colin Bergin, Elaine Hardy, Joanne Thunder, Paul Jhalli, E.G. Hartley, Catherine L. Jarvis, Carly Swann, Matthew James Reed, Bernadette Gallagher, Julia Grahamslaw, Rachel O’Brien, Timothy M. Harris, Geoffrey Bellhouse, Olivia Boulton, Imogen Skene, Adrian John Stanley, Janet L. Johnstone, Donogh Maguire, Susan Thornton, Matthew R Banks, Georgia Bercades, Daniel L. Marks, Jung Hee Ryu, Timothy M. Harris, Claire Dowty, Jason Pott, Imogen Skene, James E. East, Adam L. Bailey, Sally Beer, Siân Davies, Andrew Appelboam, Daisy Mackle, J. D. Small, Christiane Vorwerk, Rachel Atkins, I Bradbury, Tim Coats, Catriona Bryceland, Lisa McClelland, Martin V. Thomas, Kate Clayton, Angiy Michael, Stephen Haig, Saif Al-Nahhas, Tim Godfrey, Philip Boger, Rachel Comer, Barbara Watkins, Ola Afolabi, Shazad Afzal, Amanda Cowton, Simon M Everett, Ruth Fazakerley, Felicia Onoviran, Jonathon A Snook, Jackie Berry, Diane Simpson, Jeff Keep, Hannah Cotton, Sinead Helyar, Matthew D. Rutter, Tracey A. Johnston, Laura O'Rourke, Louisa Chan, Joanna Tambellini, Dawn Trodd, James Shutt, Sarah Moreton, A.J. Oglesby, Adrian A. Boyle, Nicola Haeger, Susie Hardwick, Jason Kendall, Beverley Faulkner, Ruth Worner, Sarah Hearnshaw, Mary Doona, Maria Price, Laura J Hunter, Maggie Bell, Vânia Loureiro, Anthony Kehoe, Alison Jefferey, Rosalyn Squire, David Hartin, Stephanie Bell, Alexandra A. C. Newman, James Gagg, Jayne Foot, Sue Wakeford, Gabrielle May, T. Bartram, Paul Cumpstay, Lucy Anne Parker, Rita Das, Sheik Pahary, Gavin M. Wright, Georgina Butt, Natasha Christmas, Sarah Ellen Wilson, Mohammed Ashfaq, Louise Chandler, Saif Al-Nahhas, Carrie Demetriou, Philip Kaye, Simon David Carley, Andrew E. Brown, Lucy Jones, Amanda Whileman, John Greenaway, Julie Tregonning, Timothy M. Harris, Geoffrey Bellhouse, Avril Kuhrt, Steve W. Goodacre, John M. Jones, Charlotte Owen, Anu Mitra, Abby Harper-Payne, Nigel John Trudgill, Anne Hayes, Faheem Mahmood Butt, Gayle M. Clifford, Andrew Kinnon, Susan A. Fowler, K. Vijayaprasanthan Pillay, Shweta Gidwani, Alistair McNair, Omer Omer, Tanya de Weymarn, Adnan Amin, Louisa Chan, Jane M. Martin, Nick Mathieu, Simon Barnes, James L. Turvill, Helen N. Sweeting, Morten Draegebo, M Mcnaught, Mandy Grocutt, Jordi Margalef, Julian Humphrey, Richard F. W. Jackson, Fionn Bellis, Jane Hunt, Anu Mitra, Alastair R. L. Stevenson, Nicholas Watson, Steven Barden, Stuart Paterson, Andrew Veitch, Chris Macdonald, David I. Hobday, Olu Orugun, Andrew Allison, Tristan Dyer, Samuel McBride, Wojciech Sawicki, Ben Rayner, Lynsey Flowerdew, Jamie A Barbour, Jason Klein, Stephen Hood, Nicola Palmer, Jacob de Wolff, Achuth H. Shenoy, Nigel John Trudgill, Peter Swallow, Rajaventhan Srirajaskanthan, Irshad Hussain, Hamza Arshad, Naeem Aslam, Anam Bangash, Muhammad Adeel Qamar, Haroon Zahoor, Muttiullah Mutti, Saba Arshad, Quratul ain Ghalib, Tehseen Hameed, Tayyaba Saif, Wajahat Shafi, Muhammad Arif Nadeem, Abid Ali, Shehroze Khan, Muhammad Muaaz, Ahmad Taj, Aamir Ghafoor, Aamir Afridi, Mansoor Ahmad, Mujahid Aslam, Sandeep Kumar, Majid Ali Soomro, Mohsin Ali, Ubedullah Bughio, Adil Chang, Sana Shaikh, Syed Masroor Ahmad, Zeeshan Ali, Marium Waqar, Aiman Mushir, Sadaf Sattar, Saifullah Goraya, Sharmeen Aslam, Nighat Fatima, Saadia Noreen, Sheraz Saleem, Fazal Rahman, Nadeem Iqbal, Mohammad Khalid, Umar Riaz, Muhammad Umar, Tayyab Saeed Akhter, Javaria A. Khan, N. R. Misbah, Muhammad Afzal, M. Shahbaz Bakht Kayani, Syed Ahmar Shah, Shahida Husain Tarar, Sherbat Khan, Yasir Iqbal, Essa Khan, Maqbool Reki, Tanveer Hussain, Shafqat Iqbal, Muhammad Khurram, Muhammad Ammar Shafi, Abrar Shaikh, Aijaz Ahmed, Ameet Kumar, Pinkey Sachdev, Khalid Mahmood Nasir, Zafar Iqbal Chaudhry, Muhammad Faizan Zubair, Ghias Un Nabi Tayyab, Junaid Mushtaq, Muhammad Nasir, Amir Mohammad Khan, Amjad Ali, Sajjad Ali, Wasim Uddin, Sohaib Ahmed, Tazaeen Kazmi, Saleh Muhammad Channa, Adeeqa Aman, Mouzam Shaikh, Tahir Habib Rizvi, Amjad Hussain, Haider Zaigham Baqai, Zakawat Rasheed, Abdus Khan, Adeela Irfan, Aamir Husain, Asifa Aslam, Khalid A. Yahya, Salman Azhar, Mansoor Ul Haq, Adeel Afzal, Muhammad Ahmad Imran, Iram Saeed, Aasim Yusuf, Mariam Hassan, Mumtaz Ali Marwat, Muhammad Ishfaq, Tahir Bashir, Santosh Kumar, Sajjad Yaqoob, Abdul Hamid Wahid, Adegboyega Akere, Tinuola Fakoya, Temitope Oke, Edries A. Tejan, Oluwole Olayemi Olaomi, Olawale Badejo, Okafor Nnaemaka, Nancy Ukwu, Olukayode Adeolu Arowolo, Adewale Abdulwasiu Aderounmu, Funmilola Olanike Wuraola, Rose Ugiagbe, Alexander Atiri, Enadeghe Eghaghe, Adeleke Adekoya, Adedayo Oluyomi Tade, Olatunji Shonoiki, Samuel Adegboyega Olatoke, Toafiq Raji, Christopher Nonso Ekwunife, Chigozirim Onyekpere, Adamu Ahmed, Daniyan Muhammad, Emuobor Aghoghor Odeghe, Olufunmilayo Adenike Lesi, Azeberoje Osueni, Adamu Samaila, Aminu Nahuche, Akande Oladimeji Ajayi, Andrew E. Dongo, Uchenna Nkemdilim Ijoma, Ademola Tolulope Adebanjo, Rufina Igetei, Monday Yilkudi, Kehinde Osisanya, Edith Nonyelum Okeke, Oguamanam Okezie Enwere, Serag Esmat, Omar Ahmed Ashoush, Mazen Ibrahim Naga, Fady Nagy, Mostafa Saiid, Ahmed A. Shaker, Hussein Khamis, Ashraf Helmy, Saafan Saafan, Mohammed Abdel Monem, Jiffre Din, Khairul Anuar Azis, Muhyuddin Brukan, Sanjay Singh, Andee Dzulkarnaen Zakaria, Shaik Farid, Nizam Hashim, Mohamad Masykurin Mafauzy, Wan Najmi, N. Al Amri, Xin Yi, Mohammad Hisyam, Elaine Ng, Zuhrirahimi Ramli, Shyang Yee Lim, Kelvin Voon, Sir Young Yam, Mohammad Shukri Jahit, Lee J, Besik Melikidze, Davit Kazaishvili, Tamar Gogichaishvili, Nino Grubelashvili, Baadur Mosidze, Gia Tomadze, Avto Megreladze, Ruxandra Opriţă, Dorina Pestroiu Calescu, Camelia Chioncel, Andrei Ragea, Bogdan Radu Mateescu, Bogdan Busuioc, Andrei Mihai Voiosu, Adrian Cotirlet, I Pintilie, Mariana Jinga, Daniel Vasile Balaban, Marcel Tanău, Lucian M Negreanu, Simona Maria Bataga, Khushboo Priya, Shankar Baral, Anuj K.C., Vijay Pratap Sah, Vijay Yadav, Ajay Adhikaree, Abdelmounem Eltayeib Abdo, Dalia Alsaied Moustafa Ahmed, Marzouqah Al Anazi, Areej Al Balkhi, Conor Deasy, Joaquín Álvarez Gregori, Helio Fornieles Pérez, Arben Beqiri, Bobby Wellsh, Luke Lawton · 发表于：The Lancet · 年份：2020 · DOI：10.1016/s0140-6736(20)30848-5 · 被引用次数：402 · 研究领域：Blood transfusion and management、Trauma, Hemostasis, Coagulopathy, Resuscitation、Gastrointestinal Bleeding Diagnosis and Treatment

BACKGROUND: Tranexamic acid reduces surgical bleeding and reduces death due to bleeding in patients with trauma. Meta-analyses of small trials show that tranexamic acid might decrease deaths from gastrointestinal bleeding. We aimed to assess the effects of tranexamic acid in patients with gastrointestinal bleeding. METHODS: We did an international, multicentre, randomised, placebo-controlled trial in 164 hospitals in 15 countries. Patients were enrolled if the responsible clinician was uncertain whether to use tranexamic acid, were aged above the minimum age considered an adult in their country (either aged 16 years and older or aged 18 years and older), and had significant (defined as at risk of bleeding to death) upper or lower gastrointestinal bleeding. Patients were randomly assigned by selection of a numbered treatment pack from a box containing eight packs that were identical apart from the pack number. Patients received either a loading dose of 1 g tranexamic acid, which was added to 100 mL infusion bag of 0·9% sodium chloride and infused by slow intravenous injection over 10 min, followed by a maintenance dose of 3 g tranexamic acid added to 1 L of any isotonic intravenous solution and infused at 125 mg/h for 24 h, or placebo (sodium chloride 0·9%). Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcome was death due to bleeding within 5 days of randomisation; analysis excluded patients who received neither dose of the alloca...