Liberal Transfusion Strategy in Elderly Patients

NCT03369210 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: 139/17F
• Study Type: interventional
• Target: 2,470
• Locations: 1 country
• Sites: 14

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

Outcome Measures

Primary Outcomes (1)

• 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.

  90 days

Secondary Outcomes (10)

• Proportion of patients receiving red blood cell transfusion

  hospital discharge (an anticipated average of 10 days)

• Number of red blood cell units transfused

  hospital discharge (an anticipated average of 10 days)

• Total length of stay in the intensive care unit

  hospital discharge (an anticipated average of 10 days)

• Total length of stay in hospital

  hospital discharge (an anticipated average of 10 days)

• Number of participants with acute kidney injury stage I-II

  hospital discharge (an anticipated average of 10 days)

Study Arms (2)

Liberal

EXPERIMENTAL

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)).

Drug: red blood cell transfusion trigger

Restrictive

ACTIVE COMPARATOR

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).

Drug: red blood cell transfusion trigger

Interventions

red blood cell transfusion trigger DRUG

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

Liberal; Restrictive

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johann Wolfgang Goethe University Hospital: lead
• Wuerzburg University Hospital: collaborator

Study Sites (14)

University Hospital Augsburg

Augsburg, Germany

Location

Berlin Charite CCM

Berlin, Germany

Location

Charite Berlin CBF

Berlin, Germany

Location

University Hospital Bonn

Bonn, Germany

Location

Klinikum Dortmund

Dortmund, Germany

Location

University Hospital Frankfurt

Frankfurt, Germany

Location

University Hospital Hamburg

Hamburg, Germany

Location

University Hospital Jena

Jena, Germany

Location

University Hospital Schleswig-Holstein

Kiel, Germany

Location

University Hospital Mainz

Mainz, Germany

Location

St. Franziskus Hospital Münster

Münster, Germany

Location

University Hospital Münster

Münster, Germany

Location

University Hospital Regensburg

Regensburg, Germany

Location

University Hospital Würzburg

Würzburg, 97080, Germany

Location

Related Publications (4)

• 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(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.

  PMID: 41114449 DERIVED

• 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.

  PMID: 38780066 DERIVED

• 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.

  PMID: 34932836 DERIVED

• 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.

  PMID: 30717805 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Patrick Meybohm, MD

  Wuerzburg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Patrick Meybohm

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 11, 2017
• Study Start: December 4, 2017
• Primary Completion: June 30, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-08

Locations

DE (14)