Liberal Transfusion Strategy in Elderly Patients

Last updated: August 3, 2025
Sponsor: Johann Wolfgang Goethe University Hospital
Overall Status: Active - Not Recruiting

Phase

3

Condition

Surgery

Anemia

Treatment

red blood cell transfusion trigger

Clinical Study ID

NCT03369210
139/17F
  • Ages > 70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients ≥ 70 years of age scheduled for intermediate- or high-risk non-cardiacsurgery 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

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 authorisedrepresentative/ 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 asystem of beliefs (e.g. Jehovah's Witnesses)

  • preoperative autologous blood donation.

Study Design

Total Participants: 2470
Treatment Group(s): 1
Primary Treatment: red blood cell transfusion trigger
Phase: 3
Study Start date:
December 04, 2017
Estimated Completion Date:
July 31, 2026

Connect with a study center

  • RWTH Aachen

    Aachen,
    Germany

    Site Not Available

  • University Hospital Augsburg

    Augsburg,
    Germany

    Site Not Available

  • Berlin Charite CCM

    Berlin,
    Germany

    Site Not Available

  • Charite Berlin CBF

    Berlin,
    Germany

    Site Not Available

  • University Hospital Bonn

    Bonn,
    Germany

    Site Not Available

  • Klinikum Dortmund

    Dortmund,
    Germany

    Site Not Available

  • University Hospital Düsseldorf

    Düsseldorf,
    Germany

    Site Not Available

  • University Hospital Frankfurt

    Frankfurt,
    Germany

    Site Not Available

  • Justus-Liebig-Universität Giessen

    Gießen,
    Germany

    Site Not Available

  • University Hospital Greifswald

    Greifswald,
    Germany

    Site Not Available

  • University Hospital Hamburg

    Hamburg,
    Germany

    Site Not Available

  • University Hospital Jena

    Jena,
    Germany

    Site Not Available

  • University Hospital Schleswig-Holstein

    Kiel,
    Germany

    Site Not Available

  • University Hospital Schleswig-Holstein, Campus Lübeck

    Lübeck,
    Germany

    Site Not Available

  • University Hospital Mainz

    Mainz,
    Germany

    Site Not Available

  • St. Franziskus Hospital Münster

    Münster,
    Germany

    Site Not Available

  • University Hospital Münster

    Münster,
    Germany

    Site Not Available

  • University Hospital Regensburg

    Regensburg,
    Germany

    Site Not Available

  • University Hospital Würzburg

    Würzburg, 97080
    Germany

    Site Not Available

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