Liberal Transfusion Strategy in Elderly Patients

Phase 3Active Not RecruitingNCT03369210

Johann Wolfgang Goethe University Hospital2,470 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

2,470

Conditions

Transfusion-dependent Anemia Surgery Anemia

Eligibility

Sex: ALLMin age: 70 Years

Medical Language ↔ Plain English

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.

Locations (14)

University Hospital Augsburg

Augsburg, Germany

Berlin Charite CCM

Berlin, Germany

Charite Berlin CBF

Berlin, Germany

University Hospital Bonn

Bonn, Germany

Klinikum Dortmund

Dortmund, Germany

University Hospital Frankfurt

Frankfurt, Germany

University Hospital Hamburg

Hamburg, Germany

University Hospital Jena

Jena, Germany

University Hospital Schleswig-Holstein

Kiel, Germany

University Hospital Mainz

Mainz, Germany

...and 4 more locations

Outcomes

Primary Outcomes

Occurrence of a composite endpoint

Composite of death and anaemia-associated events I. All-cause mortality defined as death from any cause. II. Acute myocardial infarction confirmed by a cardiologist III. Acute ischaemic stroke confirmed by a neurologist IV. Acute kidney injury (stage III) defined according to the Kidney Disease Improving Global Outcomes criteria: Increase of plasma creatinine level ≥ 3 times within a time window of 7 days or initiation of renal replacement therapy. V. Acute mesenteric ischaemia defined as ischaemia confirmed by intervention (abdominal surgery or mesenteric angiography). VI. Acute peripheral vascular ischaemia defined as a new non-thrombotic compromised circulation in a limb confirmed by angiography and/or leading to surgery.

Time frame: 90 days