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Liberal Transfusion Strategy in Elderly Patients
Sponsor: Johann Wolfgang Goethe University Hospital
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.
Official title: Liberal Transfusion Strategy to Prevent Mortality and Anaemia-associated, Ischaemic Events in Elderly Non-cardiac Surgical Patients
Key Details
Gender
All
Age Range
70 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2470
Start Date
2017-12-04
Completion Date
2026-07-31
Last Updated
2025-08-07
Healthy Volunteers
No
Interventions
red blood cell transfusion trigger
patients receive a RBC unit with different target ranges for the post-transfusion Hb levels
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
St. Franziskus Hospital Münster
Münster, Germany
University Hospital Münster
Münster, Germany
University Hospital Regensburg
Regensburg, Germany
University Hospital Würzburg
Würzburg, Germany