Liberal transfusion strategy to prevent mortality and anaemia-associated, ischaemic events in elderly non-cardiac surgical patients (LIBERAL-Trial)

自由输血策略可预防老年非心脏手术患者的死亡率和贫血相关的缺血事件（LIBERAL 试验）

• 批准号: 286575274
• 负责人: Professor Dr. Patrick Meybohm
• 金额: --
• 依托单位: Klinik und Poliklinik für Anästhesiologie
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 资助国家: 德国
• 项目状态: 未结题
• 来源: https://gepris.dfg.de/gepris/projekt/286575274?language=en
• 关键词: Liberal; transfusion; strategy; prevent; mortality

Perioperative anaemia leads to impaired oxygen supply with a risk of vital organ ischaemia. In healthy and fit individuals, anaemia can be compensated by several mechanisms. Elderly patients, however, have less compensatory mechanisms because of multiple co-morbidities and age-related decline of functional reserves. The purpose of the study is to evaluate whether elderly surgical patients may benefit from a liberal red blood cell (RBC) transfusion strategy compared to a restrictive transfusion strategy. The LIBERAL Trial is a prospective, randomized, multicentre, controlled clinical phase IV trial randomising 2,470 elderly (≥ 70 years) patients undergoing intermediate- or high-risk non-cardiac surgery. Registered patients will be randomised only if Haemoglobin (Hb) reaches ≤ 9 g/dl during surgery or within 3 days after surgery either to the LIBERAL group (transfusion of a single RBC unit when Hb ≤ 9 g/dl with a target range for the post-transfusion Hb level of 9-10.5 g/dl) or the RESTRICTIVE group (transfusion of a single RBC unit when Hb ≤ 7.5 g/dl with a target range for the post-transfusion Hb level of 7.5-9 g/dl). The intervention per patient will be followed until hospital discharge or up to 30 days after surgery, whichever occurs first. The primary efficacy outcome is defined as a composite of all-cause mortality, acute myocardial infarction, acute ischaemic stroke, acute kidney injury (stage III), acute mesenteric ischaemia and acute peripheral vascular ischaemia within 90 days after surgery. Key secondary endpoints are percentage of patients transfused, number of RBC units, length of stay in hospital, length of stay on intensive care unit, acute kidney injury stage I-II, infections, re-hospitalisation, functional status (Barthel index), health-related quality of life, and composite components with 90 days and 1 year follow-up. We expect that until end of the 1st funding period (31.07.2022), we will have recruited 1625 patients (66%). This renewal proposal is necessary in order to allow us to continue recruitment and to randomize the remaining 34% of patients. In conclusion, the LIBERAL-Trial will evaluate whether a liberal transfusion strategy reduces the occurrence of major adverse events after non-cardiac surgery in the geriatric population compared to a restrictive strategy within 90 days after surgery. Trial registration: ClinicalTrials.gov (identifier: NCT03369210)

围手术期贫血导致氧气供应受损，有重要器官缺血的风险。在健康和健康的个体中，贫血可以通过几种机制得到补偿。然而，老年患者由于多种共病和与年龄相关的功能储备下降，代偿机制较少。本研究的目的是评估老年手术患者是否可以受益于自由红细胞（RBC）输血策略相比，限制性输血策略。LIBERAL试验是一项前瞻性、随机化、多中心、对照临床IV期试验，随机纳入了2，470例接受中度或高风险非心脏手术的老年（≥ 70岁）患者。仅当术中或术后3天内血红蛋白（Hb）达到≤ 9 g/dl时，注册患者才被随机分配至LIBERAL组（当Hb ≤ 9 g/dl时输注单个RBC单位，输血后Hb水平的目标范围为9-10.5 g/dl）或限制性组（当Hb ≤ 7.5 g/dl时输注单个RBC单位，输血后Hb水平的目标范围为7.5-9 g/dl）。将对每例患者的干预进行随访，直至出院或术后30天，以先发生者为准。主要疗效结局定义为术后90天内全因死亡、急性心肌梗死、急性缺血性卒中、急性肾损伤（III期）、急性肠系膜缺血和急性外周血管缺血的复合终点。关键次要终点为输血患者百分比、RBC单位数量、住院时间、重症监护室住院时间、I-II期急性肾损伤、感染、再住院、功能状态（Barthel指数）、健康相关生活质量以及90天和1年随访的复合组分。我们预计到第一个资助期结束（2022年7月31日），我们将招募1625例患者（66%）。为了使我们能够继续招募并对剩余的34%的患者进行随机化，有必要进行更新。总之，LIBERAL-试验将评价与术后90天内的限制性策略相比，自由输血策略是否能减少老年人群非心脏手术后主要不良事件的发生。试验注册：ClinicalTrials.gov（标识符：NCT 03369210）