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ACTIVE NOT RECRUITING
NCT03369210
PHASE3

Liberal Transfusion Strategy in Elderly Patients

Sponsor: Johann Wolfgang Goethe University Hospital

View on ClinicalTrials.gov

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

DRUG

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