Liberal Transfusion Strategy in Elderly Patients

NCT ID: NCT03369210

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 2470 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-04
• Study Completion Date: 2026-07-31

Brief 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.

Conditions

Transfusion-dependent Anemia; Surgery; Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Liberal

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)).

Group Type: EXPERIMENTAL

red blood cell transfusion trigger

Intervention Type: DRUG

patients receive a RBC unit with different target ranges for the post-transfusion Hb levels

Restrictive

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).

Group Type: ACTIVE_COMPARATOR

red blood cell transfusion trigger

Intervention Type: DRUG

patients receive a RBC unit with different target ranges for the post-transfusion Hb levels

Interventions

red blood cell transfusion trigger

patients receive a RBC unit with different target ranges for the post-transfusion Hb levels

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wuerzburg University Hospital

OTHER

Sponsor Role: collaborator

Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr. Patrick Meybohm, M.D.

Prof. Dr. Patrick Meybohm

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patrick Meybohm, MD

Role: PRINCIPAL_INVESTIGATOR

Wuerzburg University Hospital

Locations

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

Countries

Germany

References

Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10:CD002042. doi: 10.1002/14651858.CD002042.pub6.

Reference Type: DERIVED

PMID: 41114449 (View on PubMed)

Radford M, Estcourt LJ, Sirotich E, Pitre T, Britto J, Watson M, Brunskill SJ, Fergusson DA, Doree C, Arnold DM. Restrictive versus liberal red blood cell transfusion strategies for people with haematological malignancies treated with intensive chemotherapy or radiotherapy, or both, with or without haematopoietic stem cell support. Cochrane Database Syst Rev. 2024 May 23;5(5):CD011305. doi: 10.1002/14651858.CD011305.pub3.

Reference Type: DERIVED

PMID: 38780066 (View on PubMed)

Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.

Reference Type: DERIVED

PMID: 34932836 (View on PubMed)

Meybohm P, Lindau S, Treskatsch S, Francis R, Spies C, Velten M, Wittmann M, Gueresir E, Stoppe C, Kowark A, Coburn M, Selleng S, Baschin M, Jenichen G, Meersch M, Ermert T, Zarbock A, Kranke P, Kredel M, Helf A, Laufenberg-Feldmann R, Ferner M, Wittenmeier E, Gurtler KH, Kienbaum P, de Abreu MG, Sander M, Bauer M, Seyfried T, Gruenewald M, Choorapoikayil S, Mueller MM, Seifried E, Brosteanu O, Bogatsch H, Hasenclever D, Zacharowski K; LIBERAL Collaboration Group. Liberal transfusion strategy to prevent mortality and anaemia-associated, ischaemic events in elderly non-cardiac surgical patients - the study design of the LIBERAL-Trial. Trials. 2019 Feb 4;20(1):101. doi: 10.1186/s13063-019-3200-3.

Reference Type: DERIVED

PMID: 30717805 (View on PubMed)

Related Links

http://www.liberal-trial.de

Related Info

Other Identifiers

139/17F

Identifier Type: -

Identifier Source: org_study_id