EUCTR2016-004446-29-DE进行中（未招募）1 期
iberal transfusion strategy to prevent mortality and anaemia-associated, ischaemic events in elderly non-cardiac surgical patients - LIBERAL-Trial
niversity Hospital Wuerzburg, Institution under public law, represented by the Medical Director0 个研究点目标入组 2,470 人开始时间: 2017年3月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,470
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion Criteria for Registration (Step I)
- •1. Elderly patients (>= 70 years)
- •2. Undergoing intermediate- or high-risk non-cardiac surgery (according to the ESC/ESA Guidelines: surgery-related risk of cardiovascular death and myocardial infarction)
- •a. Intermediate risk (30-day risk 1-5%): e.g., intraperitoneal (splenectomy, hiatal hernia), peripheral arterial angioplasty, endovascular aneurysm repair, head and neck, major neurological/orthopaedic (hip and spine), major urological, major gynaecological, intra-thoracic surgery
- •b. High-risk (30-day risk > 5%): e.g., aortic and major vascular, open limb revascularisation, (partial) duodeno-pancreatic, (partial) liver resection, oesophagectomy, adrenal or (partial or radical) renal resection, total cystectomy
- •3. Written informed consent; obtained before surgery from the patients or from their legally authorised representative (authorisation including clinical research/clinical trials) / legal guardian, if the patient is unable to provide informed consent.
- •Inclusion Criteria for Randomisation (Step II)
- •Registered patients will be randomised only if and as soon as Hb falls <= 9 g/dl (in spite of possible autologous transfusion) during surgery (=day 0) or day 1, 2, or 3 after surgery. If Hb remains > 9 g/dl (even after a two-stage surgery) patient does not enter the main study but vital status (all-cause mortality) will be determined 90 days after surgery
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2470
排除标准
- •Exclusion Criteria for Registration (Step I)
- •1. preoperative Hb level <= 9 g/dl
- •2. chronic kidney disease requiring dialysis
- •3. suspected lack of compliance with follow-up procedures
- •4. participation in other interventional trials
- •5. expected death within 3 months
- •6. inability to provide informed consent with absence of a legally authorised representative/ legal guardian
- •7. temporary inability to provide informed consent
- •8. previous participation in our trial
- •9. Patients who are prevented from having blood and blood products according to a system of beliefs (e.g. Jehovah’s Witnesses)
- •10. preoperative autologous blood donation
- •Exclusion Criteria for Randomisation (Step II)
- •1. Occurrence of any component of composite endpoint after registration:
- •- Acute myocardial infarction
- •- Acute ischaemic stroke
- •- Acute kidney injury (stage III)
- •- Acute mesenteric ischaemia
- •- Acute peripheral vascular ischaemia
- •2. Any allogeneic blood transfusion after registration
研究者
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