Restrictive transfusion strategy for critically injured patients (RESTRIC) trial: a study protocol for a cluster-randomised, crossover non-inferiority trial
Introduction Resuscitation using blood products is critical during the acute postinjury period. However, the optimal target haemoglobin (Hb) levels have not been adequately investigated. With the restrictive transfusion strategy for critically injured patients (RESTRIC) trial, we aim to compare the...
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BMJ Publishing Group
2020-09-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/9/e037238.full |
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| author | Kaori Ito Kazuhiko Sekine Hiroaki Iijima Yutaka Kondo Takashi Tagami Mineji Hayakawa Daisuke Kudo Takayuki Ogura Tetsuya Yumoto Akira Endo Yosuke Matsumura Shigeki Kushimoto |
| author_facet | Kaori Ito Kazuhiko Sekine Hiroaki Iijima Yutaka Kondo Takashi Tagami Mineji Hayakawa Daisuke Kudo Takayuki Ogura Tetsuya Yumoto Akira Endo Yosuke Matsumura Shigeki Kushimoto |
| author_sort | Kaori Ito |
| collection | DOAJ |
| description | Introduction Resuscitation using blood products is critical during the acute postinjury period. However, the optimal target haemoglobin (Hb) levels have not been adequately investigated. With the restrictive transfusion strategy for critically injured patients (RESTRIC) trial, we aim to compare the restrictive and liberal red blood cell (RBC) transfusion strategies.Methods and analysis This is a cluster-randomised, crossover, non-inferiority trial of patients with severe trauma at 22 hospitals that have been randomised in a 1:1 ratio based on the use of a restrictive or liberal transfusion strategy with target Hb levels of 70–90 or 100–120 g/L, respectively, during the first year. Subsequently, after 1-month washout period, another transfusion strategy will be applied for an additional year. RBC transfusion requirements are usually unclear on arrival at the emergency department. Therefore, patients with severe bleeding, which could lead to haemorrhagic shock, will be included in the trial based on the attending physician’s judgement. Each RBC transfusion strategy will be applied until 7 days postadmission to the hospital or discharge from the intensive care unit. The outcomes measured will include the 28-day survival rate after arrival at the emergency department (primary), the cumulative amount of blood transfused, event-free days and frequency of transfusion-associated lung injury and organ failure (secondary). Demonstration of the non-inferiority of restrictive transfusion will emphasise its clinical advantages.Ethics and dissemination The trial will be performed according to the Japanese and International Ethical guidelines. It has been approved by the Ethics Committee of each participating hospital and The Japanese Association for the Surgery of Trauma (JAST). Written informed consent will be obtained from all patients or their representatives. The results of the trial will be disseminated to the participating hospitals and board-certified educational institutions of JAST, submitted to peer-reviewed journals for publication, and presented at congresses.Trial registration number UMIN Clinical Trials Registry; UMIN000034405. Registered 8 October 2018. |
| format | Article |
| id | doaj-art-5e56235dadd24e6fb5202879e7df0a9b |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-5e56235dadd24e6fb5202879e7df0a9b2025-01-08T05:20:12ZengBMJ Publishing GroupBMJ Open2044-60552020-09-0110910.1136/bmjopen-2020-037238Restrictive transfusion strategy for critically injured patients (RESTRIC) trial: a study protocol for a cluster-randomised, crossover non-inferiority trialKaori Ito0Kazuhiko Sekine1Hiroaki Iijima2Yutaka Kondo3Takashi Tagami4Mineji Hayakawa5Daisuke Kudo6Takayuki Ogura7Tetsuya Yumoto8Akira Endo9Yosuke Matsumura10Shigeki Kushimoto11Division of Acute Care Surgery, Department of Emergency Medicine, Teikyo University School of Medicine, Itabashi-ku, Tokyo, JapanDepartment of Emergency Medicine, Saiseikai Central Hospital, Minato-ku, Tokyo, Japan5 Clinical Research and Medical Innovation Center, Hokkaido University Hospital, Sapporo, Hokkaido, Japan10 Department of Emergency and Critical Care Medicine, Juntendo University Urayasu Hospital, Urayasu, Chiba, JapanDepartment of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, Bunkyo-ku, Tokyo, JapanDepartment of Emergency Medicine, Hokkaido University Hospital, Sapporo, JapanDivision of Emergency and Critical Care Medicine, Tohoku University School of Medicine, Sendai, Miyagi, JapanDepartment of Emergency Medicine and Critical Care Medicine, Saiseikai Utsunomiya Hospital, Utsunomiya, JapanEmergency, Critical Care, and Disaster Medicine, Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences, Okayama, JapanDepartment of Acute Critical Care Medicine, Tsuchiura Kyodo General Hospital, Tsuchiura, Ibaraki, JapanDepartment of Intensive Care, Chiba Emergency Medical Center, Chiba, Chiba, JapanDivision of Emergency and Critical Care Medicine, Tohoku University, Sendai, Miyagi, JapanIntroduction Resuscitation using blood products is critical during the acute postinjury period. However, the optimal target haemoglobin (Hb) levels have not been adequately investigated. With the restrictive transfusion strategy for critically injured patients (RESTRIC) trial, we aim to compare the restrictive and liberal red blood cell (RBC) transfusion strategies.Methods and analysis This is a cluster-randomised, crossover, non-inferiority trial of patients with severe trauma at 22 hospitals that have been randomised in a 1:1 ratio based on the use of a restrictive or liberal transfusion strategy with target Hb levels of 70–90 or 100–120 g/L, respectively, during the first year. Subsequently, after 1-month washout period, another transfusion strategy will be applied for an additional year. RBC transfusion requirements are usually unclear on arrival at the emergency department. Therefore, patients with severe bleeding, which could lead to haemorrhagic shock, will be included in the trial based on the attending physician’s judgement. Each RBC transfusion strategy will be applied until 7 days postadmission to the hospital or discharge from the intensive care unit. The outcomes measured will include the 28-day survival rate after arrival at the emergency department (primary), the cumulative amount of blood transfused, event-free days and frequency of transfusion-associated lung injury and organ failure (secondary). Demonstration of the non-inferiority of restrictive transfusion will emphasise its clinical advantages.Ethics and dissemination The trial will be performed according to the Japanese and International Ethical guidelines. It has been approved by the Ethics Committee of each participating hospital and The Japanese Association for the Surgery of Trauma (JAST). Written informed consent will be obtained from all patients or their representatives. The results of the trial will be disseminated to the participating hospitals and board-certified educational institutions of JAST, submitted to peer-reviewed journals for publication, and presented at congresses.Trial registration number UMIN Clinical Trials Registry; UMIN000034405. Registered 8 October 2018.https://bmjopen.bmj.com/content/10/9/e037238.full |
| spellingShingle | Kaori Ito Kazuhiko Sekine Hiroaki Iijima Yutaka Kondo Takashi Tagami Mineji Hayakawa Daisuke Kudo Takayuki Ogura Tetsuya Yumoto Akira Endo Yosuke Matsumura Shigeki Kushimoto Restrictive transfusion strategy for critically injured patients (RESTRIC) trial: a study protocol for a cluster-randomised, crossover non-inferiority trial BMJ Open |
| title | Restrictive transfusion strategy for critically injured patients (RESTRIC) trial: a study protocol for a cluster-randomised, crossover non-inferiority trial |
| title_full | Restrictive transfusion strategy for critically injured patients (RESTRIC) trial: a study protocol for a cluster-randomised, crossover non-inferiority trial |
| title_fullStr | Restrictive transfusion strategy for critically injured patients (RESTRIC) trial: a study protocol for a cluster-randomised, crossover non-inferiority trial |
| title_full_unstemmed | Restrictive transfusion strategy for critically injured patients (RESTRIC) trial: a study protocol for a cluster-randomised, crossover non-inferiority trial |
| title_short | Restrictive transfusion strategy for critically injured patients (RESTRIC) trial: a study protocol for a cluster-randomised, crossover non-inferiority trial |
| title_sort | restrictive transfusion strategy for critically injured patients restric trial a study protocol for a cluster randomised crossover non inferiority trial |
| url | https://bmjopen.bmj.com/content/10/9/e037238.full |
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