Liberal Transfusion Strategy to Prevent Mortality and Anaemia-associated, Ischaemic Events in Elderly Non-cardiac Surgical Patients

139/17F

In this prospective, multicentre, open, randomised, controlled clinical trial elderly patients (≥ 70 years) undergoing intermediate- or high-risk non-cardiac surgery will be randomised either to a liberal group (patients receive a RBC unit each time Hb falls ≤ 9 g/dl (≤ 5.6mmol/l) with a target range for the post-transfusion Hb level of 9-10.5 g/dl (5.6-6.5 mmol/l)) or restrictive group (patients receive a single RBC unit each time Hb falls ≤ 7.5 g/dl (≤ 4.7 mmol/l) with a target range for the post-transfusion Hb level of 7.5-9 g/dl (4.7-5.6 mmol/l). Primary efficacy endpoint: is a composite of death from any cause and anaemia-associated, ischaemic events (defined as acute myocardial infarction, acute ischaemic stroke, acute kidney injury stage III, acute mesenteric ischaemia, acute peripheral vascular ischaemia) within 90 days after surgery.

2017-12-04

2024-12-31

2025-12-31

Recruiting

Early phase I

2470

Inclusion Criteria: * Patients ≥ 70 years of age scheduled for intermediate- or high-risk non-cardiac surgery will be registered * Registered patients will be randomised only if they indeed develop severe anaemia (if Hb level falls ≤ 9 g/dl) during surgery (=day 0) or day 1, 2, or 3 after surgery Exclusion Criteria: * preoperative Hb level ≤ 9 g/dl * chronic kidney disease requiring dialysis * suspected lack of compliance with follow-up procedures * participation in other interventional trials * expected death within 3 months * inability to provide informed consent with absence of a legally authorised representative/ legal guardian * temporary inability to provide informed consent * previous participation in our trial * patients who are prevented from having blood and blood products according to a system of beliefs (e.g. Jehovah's Witnesses) * preoperative autologous blood donation.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 2470, 'type': 'ESTIMATED'}}

2024-03-05