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NCT Number: NCT03369210

Liberal Transfusion Strategy in Elderly Patients

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.

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Key information

Conditions

Transfusion-dependent Anemia Anemia Hematologic Diseases Hemic and Lymphatic Diseases Surgery

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital RWTH, Aachen, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

red blood cell transfusion trigger

Drug

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

Primary outcomes

  1. Occurrence of a composite outcome

    Time frame: 90 days

    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.

Secondary outcomes

  1. Proportion of patients receiving red blood cell transfusion

    Time frame: hospital discharge (an anticipated average of 10 days)

  2. Number of red blood cell units transfused

    Time frame: hospital discharge (an anticipated average of 10 days)

  3. Total length of stay in the intensive care unit

    Time frame: hospital discharge (an anticipated average of 10 days)

  4. Total length of stay in hospital

    Time frame: hospital discharge (an anticipated average of 10 days)

  5. Number of participants with acute kidney injury stage I-II

    Time frame: hospital discharge (an anticipated average of 10 days)

    The occurrence of acute kidney injury (stage I or II) defined according to the Kidney Disease Improving Global Outcomes criteria (stage I: increase of plasma creatinine level ≥ 1.5-1.9 times baseline or ≥ 0.3mg/dl within 48 hours; stage II: increase of plasma creatinine level ≥ 2-2.9 times baseline within a time window of 7 days) during the initial hospital stay

  6. Time to infection

    Time frame: 90 days

    Time to (first) infection (infection requiring therapeutic intravenous antibiotic treatment (pneumonia, wound infection, sepsis, central line associated blood stream infection)) during the initial hospital stay or leading to hospital re-admission

  7. Time to re-hospitalisation

    Time frame: 90 days

    Time to (first) re-hospitalisation

  8. functional status (Barthel index)

    Time frame: 90 days

    Functional status (assessed by Barthel Index)

  9. Health-related quality of life

    Time frame: 90 days

    Health-related quality of life (assessed by EuroQoL EQ-5D and 12-item World Health Organisation Disability Assessment Schedule WHODAS 2.043) by telephone questionnaire)

  10. Occurrence of any individual component of the composite

    Time frame: 1 year

    composite components (all-cause mortality, acute myocardial infarction, acute stroke, acute kidney injury stage III, acute mesenteric ischaemia, and/or acute peripheral vascular ischaemia)

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Collaborators

  • Wuerzburg University Hospital

Registry information

Official study title

Liberal Transfusion Strategy to Prevent Mortality and Anaemia-associated, Ischaemic Events in Elderly Non-cardiac Surgical Patients

Acronym: LIBERAL

Important dates

Study start
2018
Primary completion
2025
Study completion
2026
First posted
Dec 11, 2017
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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