使用羧基麦芽糖铁和氨甲环酸进行围手术期管理以降低妇科癌手术中的输血率（TRANAFER 研究）：一项单盲、单中心、随机试验的研究方案。

Perioperative management with ferric carboxymaltose and tranexamic acid to reduce transfusion rate in gynaecological carcinoma surgery (TRANAFER-Study): study protocol for a single-blind, monocentre, randomised trial.

机构信息

Department of Obstetrics and Gynaecology, University Hospital Basel, Basel, Switzerland

Department of Obstetrics and Gynaecology, University Hospital Basel, Basel, Switzerland.

出版信息

BMJ Open. 2022 Sep 26;12(9):e057381. doi: 10.1136/bmjopen-2021-057381.

DOI:10.1136/bmjopen-2021-057381

PMID:36167367

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9516161/

Abstract

INTRODUCTION

Radical abdominal surgery is part of the standard treatment for women with advanced gynaecological carcinoma. The surgery often leads to intraoperative blood loss frequently exceeding 1000 mL. Approximately 50% of women undergoing radical surgery require blood transfusions. Perioperative blood transfusions have been shown to increase the risk of postoperative complications, delayed wound healing, increased length of stay, increased postoperative morbidity and mortality. Previous studies have demonstrated an association between perioperative anaemia and surgical morbidity and mortality. By reducing transfusions and improving recovery from surgery, preoperative diagnostic and management of perioperative anaemia is a great opportunity to optimise postoperative patient outcome.

METHODS AND ANALYSIS

This is a single-blind, monocentre, randomised trial with four parallel groups (three therapeutic groups and one control group without treatment according to current standards of care) conducted in women undergoing radical gynaecological surgery. The primary study objective is to determine the effect of perioperative treatment with either intravenous iron, tranexamic acid or with a combination of both medicines on the reduction of intraoperative and postoperative red blood cell transfusions in gynaecological carcinoma patients. A total of N=126 women with gynaecological carcinoma will be recruited at the University Hospital Basel, Department of Gynaecology. Blood parameters will be measured at the recruitment, prior to surgery, 2 days after surgery and on the 21st-28th day after surgery. Recruitment started in August 2021.

ETHICS AND DISSEMINATION

The study will be performed according to the guidelines of the Declaration of Helsinki and is approved by the Ethics Committee for Northwest and Central Switzerland in Basel (EKNZ Protocol ID 2020-01194). The results of this study will be published and presented in various scientific forums.

TRIAL REGISTRATION NUMBER

NCT03792464.

摘要

简介

根治性腹部手术是晚期妇科癌患者标准治疗的一部分。该手术常导致术中出血量经常超过 1000 毫升。大约 50%接受根治性手术的女性需要输血。围手术期输血已被证明会增加术后并发症、伤口愈合延迟、住院时间延长、术后发病率和死亡率的风险。先前的研究表明围手术期贫血与手术发病率和死亡率之间存在关联。通过减少输血和改善手术恢复，围手术期贫血的术前诊断和管理是优化术后患者结局的绝佳机会。

方法和分析

这是一项单盲、单中心、随机试验，设有四个平行组（三个治疗组和一个不根据当前护理标准进行治疗的对照组），在接受根治性妇科手术的女性中进行。主要研究目的是确定围手术期使用静脉铁、氨甲环酸或两者联合治疗对减少妇科癌患者术中及术后红细胞输血的影响。共有 126 名妇科癌患者将在巴塞尔大学医院妇科招募。将在招募时、手术前、手术后 2 天和手术后 21-28 天测量血液参数。招募于 2021 年 8 月开始。