Liberal Transfusion Strategy in Elderly Patients

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Patrick Meybohm, M.D.

Criteria

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.