Liberal Transfusion Strategy in Elderly Patients (LIBERAL)

Johann Wolfgang Goethe University Hospital

Status and phase: Active, not recruiting; Phase 3

Conditions: Anemia; Surgery; Transfusion-dependent Anemia

Treatments: Drug: red blood cell transfusion trigger

Study type: Interventional

Funder types: Other

Identifiers

NCT03369210

139/17F

Details and patient eligibility

About

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.

Enrollment: 2,470 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,470 participants in 2 patient groups

Liberal

Experimental group

Description:

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)).

Treatment:

Drug: red blood cell transfusion trigger

Restrictive

Active Comparator group

Description:

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).

Treatment:

Drug: red blood cell transfusion trigger