{"title":"非心脏手术个体化红细胞输注策略的评分:一项多中心、随机、对照试验的研究方案","authors":"L. Ren, Sun Hao-Rui, Liu Jin","doi":"10.24015/JAPM.2016.0030","DOIUrl":null,"url":null,"abstract":"Background: Transfusion trigger and target for surgical patients with hemoglobin level between 6-10 grams per deciliter (gram per deciliter) is not implemented worldwide. The decision of whether red cells should be given to these patients is often made according to the experience of clinicians without specific clinical or laboratory evidence. Based on the physiology of the balance between oxygen supply and consumption, we developed the West China Liu's Score that will help clinicians to make individualized transfusion decisions for patients undergoing elective non-cardiac major surgery. The aim of this study is to determine whether the individualized red cells transfusion strategy, when compared with restrictive transfusion strategy (red cells transfusion trigger based on the judgment of physicians according to current transfusion guidelines) and liberal transfusion strategy (red cells transfusion trigger of 10 grams per deciliter), will decrease red cells transfusion requirement without increasing mortality or postoperative complications, or delaying incision healing, or increasing the cost of hospitalization.Methods and Design: This trial is a prospective, multicenter, randomized controlled trial that will test the superiority of the individualized transfusion strategy to restrictive transfusion strategy and liberal transfusion strategy in terms of reducing red cells transfusion demands safely and effectively. A total of 4200 patients undergoing elective major surgery with estimated intra-operative blood loss more than 1000 ml or 20% of total blood volume and perioperative hemoglobin less than 10 grams per deciliter will be randomized into individualized-strategy group, restrictive-strategy group, and liberal-strategy group. The primary outcomes of the study are the incidences of red cells transfusion and combination of in-hospital death for any reason and serious complications.Discussion: The individualized transfusion strategy guided by application of West China Liu's score will provide a new insight on the perioperative transfusion practice and new clinical proof for the transfusion guidelines.Trial Registration: This trial was registered at ClinicalTrials.gov (identifier NCT01597232) on 14 May 2012. Citation: Ren Liao, Hao-Rui Sun, Jin Liu. West China Liu's Score for individualized red cells transfusion strategy in non-cardiac surgery: study protocol for a multicenter, randomized, controlled trial. J Anesth Perioper Med 2016; 3: 225-32. doi: 10.24015/JAPM.2016.0030This is an open-access article, published by Evidence Based Communications (EBC). This work is licensed under the Creative Commons Attribution 4.0 International License, which permits unrestricted use, distribution, and reproduction in any medium or format for any lawful purpose. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.","PeriodicalId":15018,"journal":{"name":"Journal of Anesthesia and Perioperative Medicine","volume":"9 1","pages":"225-232"},"PeriodicalIF":0.0000,"publicationDate":"2016-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":"{\"title\":\"West China Liu's Score for Individualized Red Cells Transfusion Strategy in Non-Cardiac Surgery: Study Protocol for a Multicenter, Randomized, Controlled Trial\",\"authors\":\"L. Ren, Sun Hao-Rui, Liu Jin\",\"doi\":\"10.24015/JAPM.2016.0030\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Background: Transfusion trigger and target for surgical patients with hemoglobin level between 6-10 grams per deciliter (gram per deciliter) is not implemented worldwide. The decision of whether red cells should be given to these patients is often made according to the experience of clinicians without specific clinical or laboratory evidence. Based on the physiology of the balance between oxygen supply and consumption, we developed the West China Liu's Score that will help clinicians to make individualized transfusion decisions for patients undergoing elective non-cardiac major surgery. The aim of this study is to determine whether the individualized red cells transfusion strategy, when compared with restrictive transfusion strategy (red cells transfusion trigger based on the judgment of physicians according to current transfusion guidelines) and liberal transfusion strategy (red cells transfusion trigger of 10 grams per deciliter), will decrease red cells transfusion requirement without increasing mortality or postoperative complications, or delaying incision healing, or increasing the cost of hospitalization.Methods and Design: This trial is a prospective, multicenter, randomized controlled trial that will test the superiority of the individualized transfusion strategy to restrictive transfusion strategy and liberal transfusion strategy in terms of reducing red cells transfusion demands safely and effectively. A total of 4200 patients undergoing elective major surgery with estimated intra-operative blood loss more than 1000 ml or 20% of total blood volume and perioperative hemoglobin less than 10 grams per deciliter will be randomized into individualized-strategy group, restrictive-strategy group, and liberal-strategy group. The primary outcomes of the study are the incidences of red cells transfusion and combination of in-hospital death for any reason and serious complications.Discussion: The individualized transfusion strategy guided by application of West China Liu's score will provide a new insight on the perioperative transfusion practice and new clinical proof for the transfusion guidelines.Trial Registration: This trial was registered at ClinicalTrials.gov (identifier NCT01597232) on 14 May 2012. Citation: Ren Liao, Hao-Rui Sun, Jin Liu. West China Liu's Score for individualized red cells transfusion strategy in non-cardiac surgery: study protocol for a multicenter, randomized, controlled trial. J Anesth Perioper Med 2016; 3: 225-32. doi: 10.24015/JAPM.2016.0030This is an open-access article, published by Evidence Based Communications (EBC). This work is licensed under the Creative Commons Attribution 4.0 International License, which permits unrestricted use, distribution, and reproduction in any medium or format for any lawful purpose. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.\",\"PeriodicalId\":15018,\"journal\":{\"name\":\"Journal of Anesthesia and Perioperative Medicine\",\"volume\":\"9 1\",\"pages\":\"225-232\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2016-09-18\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Anesthesia and Perioperative Medicine\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.24015/JAPM.2016.0030\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Anesthesia and Perioperative Medicine","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.24015/JAPM.2016.0030","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
West China Liu's Score for Individualized Red Cells Transfusion Strategy in Non-Cardiac Surgery: Study Protocol for a Multicenter, Randomized, Controlled Trial
Background: Transfusion trigger and target for surgical patients with hemoglobin level between 6-10 grams per deciliter (gram per deciliter) is not implemented worldwide. The decision of whether red cells should be given to these patients is often made according to the experience of clinicians without specific clinical or laboratory evidence. Based on the physiology of the balance between oxygen supply and consumption, we developed the West China Liu's Score that will help clinicians to make individualized transfusion decisions for patients undergoing elective non-cardiac major surgery. The aim of this study is to determine whether the individualized red cells transfusion strategy, when compared with restrictive transfusion strategy (red cells transfusion trigger based on the judgment of physicians according to current transfusion guidelines) and liberal transfusion strategy (red cells transfusion trigger of 10 grams per deciliter), will decrease red cells transfusion requirement without increasing mortality or postoperative complications, or delaying incision healing, or increasing the cost of hospitalization.Methods and Design: This trial is a prospective, multicenter, randomized controlled trial that will test the superiority of the individualized transfusion strategy to restrictive transfusion strategy and liberal transfusion strategy in terms of reducing red cells transfusion demands safely and effectively. A total of 4200 patients undergoing elective major surgery with estimated intra-operative blood loss more than 1000 ml or 20% of total blood volume and perioperative hemoglobin less than 10 grams per deciliter will be randomized into individualized-strategy group, restrictive-strategy group, and liberal-strategy group. The primary outcomes of the study are the incidences of red cells transfusion and combination of in-hospital death for any reason and serious complications.Discussion: The individualized transfusion strategy guided by application of West China Liu's score will provide a new insight on the perioperative transfusion practice and new clinical proof for the transfusion guidelines.Trial Registration: This trial was registered at ClinicalTrials.gov (identifier NCT01597232) on 14 May 2012. Citation: Ren Liao, Hao-Rui Sun, Jin Liu. West China Liu's Score for individualized red cells transfusion strategy in non-cardiac surgery: study protocol for a multicenter, randomized, controlled trial. J Anesth Perioper Med 2016; 3: 225-32. doi: 10.24015/JAPM.2016.0030This is an open-access article, published by Evidence Based Communications (EBC). This work is licensed under the Creative Commons Attribution 4.0 International License, which permits unrestricted use, distribution, and reproduction in any medium or format for any lawful purpose. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.