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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

氨甲环酸 医学 安慰剂 胃肠道出血 麻醉 随机对照试验 外科 失血 病理 替代医学
作者
Ian Roberts,Haleema Shakur-Still,Adefemi Afolabi,Adegboyega Akere,Mònica Arribas,Amy Brenner,Rizwana Chaudhri,Ian Gilmore,Kenneth Halligan,Irshad Hussain,Vipul Jairath,Kiran Javaid,Aasia Kayani,Ton Lisman,Raoul Mansukhani,Muttiullah Mutti,Muhammad Arif Nadeem,Richard Pollok,Jonathan Simmons,Majid Ali Soomro,Simon Stanworth,Andrew Veitch,Christopher J. Hawkey,Jack Cuzick,David Henry,Chris Metcalfe,Richard Gray,Alan N. Barkun,Suresh S. David,P.J. Devereaux,Tony Brady,Timothy Coats,Phil Edwards,Katharine Ker,Daniela Manno,Emma Austin,Kiran Bal,Eni Balogun,Collette Barrow,Danielle Beaumont,Myriam Benyahia,Imogen Brooks,Madeleine Cargill,Laura Carrington,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,Sergey Kostrov,Hakim Miah,Bernard Ndungu,Kelly Needham,Aroudra Outtandy,Daniel Pearson,Tracey Pepple,Danielle Prowse,Nigel Quashi,Anna Quinn,María Victoria Carballo Calero Ramos,Laura Ranopa,Mia Reid,Chris Roukas,Chelci Squires,Jemma Tanner,Andrew Thayne,Ruhama Uddin,Bukola Fawole,Folasade Adenike Bello,Oladapo Olayemi,Olujide Okunade,Oluwadamilola Adetayo,Hussein Khamis,Mohammad Shukri Jahit,Tamar Gogichaishvili,Radu Bogdan Mateescu,Ajay Adhikaree,Abdelmounem Abdo,Mohammad Abduz Zaher,Conor Deasy,Joaquin Alvarez-Gregori,Bobby Michael Wellsh,Luke Lawton,Raghavendra Kamath,Adrian Barry,Racquel Carpio,Kay Finney,Holly Maguire,Martin James,Frank Coffey,Chris Gough,Lisa Sawers,Aye-Aye Thi,Claire Burnett,Nicola Jacques,Victoria Murray,Heather Jarman,Christine Lambe,Sarah. Rounding,Simon Tucker,Romaih Al-Idari,Samuel I. Guest,Emma Stoddard,David Yeo,Colin Bergin,Elaine Hardy,Joanne Thunder,Paul Jhalli,E.C. Hartley,Catherine Jarvis,Carly Swann,Matthew J Reed,Bernadette Gallagher,Julia Grahamslaw,Rachel O’Brien,T. J. R. Harris,Geoffrey Bellhouse,Olivia Boulton,Imogen Skene,Adrian Stanley,Janet Johnstone,Donogh Maguire,Susan Thornton,Matthew Banks,Georgia Bercades,Daniel Marks,Jung Hee Ryu,Claire Dowty,Jason Pott,James E. East,Adam Bailey,Sally Beer,Siân Davies,Andrew Appelboam,Daisy Mackle,J. G. Small,Christiane Vorwerk,Rachel M. Atkins,I Bradbury,Catriona Bryceland,Lisa McClelland,Martin G. 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 Everett,Ruth Fazakerley,Felicia Onoviran,Jonathon Snook,Jackie Berry,Diane Simpson,Jeff Keep,Hannah Cotton,Sinead Helyar,Matthew D. Rutter,Tracey Johnston,Laura O'Rourke,Louisa Chan,Joanna Tambellini,Dawn Trodd,James Shutt,Sarah Moreton,Abby Oglesby,Adrian Boyle,Nicola Haeger,Susie. Hardwick,Jason Kendall,Beverley Faulkner,Ruth Worner,Sarah Hearnshaw,Mary Doona,Maria Price,Laura Hunter,Maggie Bell,Vânia Loureiro,Anthony Kehoe,Alison Jefferey,Rosalyn Squire,David Hartin,Stephanie Bell,Alexandra Newman,James Gagg,Jayne Foot,Sue Wakeford,Gabrielle May,Thomas Bartram,Paul Cumpstay,Lucy Parker,Rita Das,Sheik Pahary,Gavin Wright,Georgina Butt,Natasha Christmas,Sarah Wilson,Mohammed Ashfaq,Louise Chandler,Carrie Demetriou,Philip Kaye,Simon Carley,Andrew Brown,Lucy Jones,Amanda Whileman,John Greenaway,Julie Tregonning,Avril Kuhrt,Steve Goodacre,John J. Jones,Charlotte H. Owen,Anu Mitra,Abby Harper-Payne,Nigel Trudgill,Anne Hayes,Faheem Butt,Gayle Clifford,Andrew Kinnon,Susan A. Fowler,K. G. Pillay,Shweta Gidwani,Alistair McNair,Omer Omer,Tanya de Weymarn,Adnan Amin,Jane Martin,Nick Mathieu,Simon Barnes,James Turvill,Helen Sweeting,Morten Draegebo,Marion McNaught,Mandy Grocutt,Jordi Margalef,Julian Humphrey,Richard A. Jackson,Fionn Bellis,Jane Hunt,Alastair R. L. Stevenson,Nicholas Watson,Steven Barden,S. K. Paterson,Chris Ewen MacDonald,David Hobday,Olu Orugun,Andrew Allison,Tristan Dyer,Samuel McBride,Wojciech Sawicki,Ben Rayner,Lynsey Flowerdew,Jamie Barbour,Jason Klein,Stephen Hood,Nicola Palmer,Jacob de Wolff,Achuth Shenoy,Peter Swallow,Rajaventhan Srirajaskanthan,Hamza Arshad,Naeem Aslam,Anam Bangash,Muhammad Adeel Qamar,Haroon Zahoor,Saba Arshad,Quratul ain Ghalib,Tehseen Hameed,Tayyaba Saif,Wajahat Shafi,A. E. Ali,Shehroze Khan,Muhammad Muaaz,Ahmad Taj,Aamir Ghafoor,Aamir Afridi,Mansoor Ahmad,Mujahid Aslam,Sandeep Kumar,Mohsin Ali,Ubedullah Bughio,Adil Hassan Chang,Sana Shaikh,Syed Masroor Ahmad,Zeeshan Ali,Marium Fatima 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 Khan,Noureen Misbah,Muhammad R. Afzal,M. Shahbaz Bakht Kayani,Syed M. Shah,Shahida Husain Tarar,Sherbat Khan,Yasir Iqbal,Essa Khan,Maqbool Reki,Tanveer Hussain,Shafqat Iqbal,Muhammad Khurram,Muhammad Shafi,Abrar Shaikh,Aijaz Ahmed,Ameet Kumar,Pinkey Sachdev,Khalid Mahmood Nasir,Zafar Iqbal Chaudhry,M. Mujeeb Zubair,Ghias Un Nabi Tayyab,Junaid Mushtaq,Muhammad Nasir,Amir Mohammad Khan,Amjad Ali,Sajjad Ali,Wasim Uddin,Sohaib Ahmed,Tazaeen Kazmi,Saleh Channa,Adeeqa Aman,Mouzam Shaikh,Tahir Habib Rizvi,Amjad Hussain,Haider Zaigham Baqai,Zakawat Rasheed,Abdus Samad Khan,Adeela Irfan,Aamir Husain,Asifa Aslam,Khalid Mahmood Yahya,Salman Azhar,Mansoor Ul Haq,Adeel Afzal,Muhammad Imran,Iram Saeed,Aasim Yusuf,Mariam Hassan,Mumtaz Ali Marwat,Muhammad Ishfaq,Tahir Bashir,Santosh Kumar,Sajjad Yaqoob,Abdul Wahid,T.O. Fakoya,Temitope Oke,Edries Ahmad Tejan,Oluwole Olaomi,Olawale Badejo,Okafor Nnaemaka,Nancy Ukwu,Olukayode Arowolo,A F Aderounmu,Funmilola Wuraola,Rose Ugiagbe,Alexander Atiri,Enadeghe Eghaghe,A. O. Adekoya,A O Tade,Olatunji Shonoiki,Samuel Olatoke,Toafiq Raji,Christopher N Ekwunife,Chigozirim Onyekpere,Adamu Ahmed,Muhammad Daniyan,Emuobor Odeghe,Olufunmilayo Lesi,Azeberoje Osueni,Adamu Alhaji Samaila,Aminu Nahuche,Akande Oladimeji Ajayi,Andrew E. Dongo,Uchenna Ijoma,Ademola Adebanjo,R Igetei,Monday Yilkudi,Kehinde Osisanya,Edith Okeke,Oguamanam Okezie Enwere,Serag Esmat,Omar Ashoush,Mazen Naga,Fady Nagy,Mostafa Saiid,Ahmed Shaker,Ashraf A Helmy,Saafan Saafan,Mohammed Monem,Jiffre Din,Khairul Azis,Muhyuddin Brukan,Sanjay Singh,Andee Dzulkarnaen Zakaria,Shaik Farid,Nizam Hashim,M Mafauzy,Wan Najmi,Nil Amri,Xin Yi,Mohammad Hisyam,Elaine Ng,Zuhrirahimi Ramli,Shyang Yee Lim,Kelvin Voon,Sir Young Yam,Mohammad Shukri Jahit,Joon Lee,Besik Melikidze,Davit Kazaishvili,Nino Grubelashvili,Baadur Mosidze,Gia Tomadze,Avto Megreladze,Ruxandra Opriță,Dorina Pestroiu Calescu,Camelia Chioncel,Andrei Ragea,Bogdan Mateescu,Bogdan Busuioc,Andrei Voiosu,Adrian Cotirlet,Iulia Pintilie,Mariana Jinga,Daniel Vasile Balaban,Marcel Tanău,Lucian Negreanu,Simona Băţagă,Khushboo Priya,Shankar Baral,K C Anuj,Vijay Pratap Sah,Vijay Yadav,Abdelmounem Abdo,Dalia Dafa Alla Osman Sid Ahmed,Marzouqah Al Anazi,Areej Al Balkhi,Helio Fornieles Pérez,Arben Beqiri
出处
期刊:The Lancet [Elsevier]
卷期号:395 (10241): 1927-1936 被引量:224
标识
DOI:10.1016/s0140-6736(20)30848-5
摘要

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.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 allocated treatment and those for whom outcome data on death were unavailable. This trial was registered with Current Controlled Trials, ISRCTN11225767, and ClinicalTrials.gov, NCT01658124.Between July 4, 2013, and June 21, 2019, we randomly allocated 12 009 patients to receive tranexamic acid (5994, 49·9%) or matching placebo (6015, 50·1%), of whom 11 952 (99·5%) received the first dose of the allocated treatment. Death due to bleeding within 5 days of randomisation occurred in 222 (4%) of 5956 patients in the tranexamic acid group and in 226 (4%) of 5981 patients in the placebo group (risk ratio [RR] 0·99, 95% CI 0·82-1·18). Arterial thromboembolic events (myocardial infarction or stroke) were similar in the tranexamic acid group and placebo group (42 [0·7%] of 5952 vs 46 [0·8%] of 5977; 0·92; 0·60 to 1·39). Venous thromboembolic events (deep vein thrombosis or pulmonary embolism) were higher in tranexamic acid group than in the placebo group (48 [0·8%] of 5952 vs 26 [0·4%] of 5977; RR 1·85; 95% CI 1·15 to 2·98).We found that tranexamic acid did not reduce death from gastrointestinal bleeding. On the basis of our results, tranexamic acid should not be used for the treatment of gastrointestinal bleeding outside the context of a randomised trial.UK National Institute for Health Research Health Technology Assessment Programme.
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