Liberal transfusion strategy to prevent mortality and anaemia-associated, ischaemic events in elderly non-cardiac surgical patients

Liberal transfusion strategy to prevent mortality and anaemia-associated, ischaemic events in elderly non-cardiac surgical patients - LIBERAL-Trial

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004446-29-DE

Enrollment

2470

Registered

2017-03-21

Start date

2017-10-30

Completion date

Unknown

Last updated

2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly patients (>= 70 years) undergoing intermediate- or high-risk non-cardiac surgery MedDRA version: 27.0 Level: PT Classification code 10048861 Term: Anaemia postoperative System Organ Class: 10022117 - Injury, poisoning and procedural complications

Interventions

Product Name: Red Blood Cell Concentrate Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RED BLOOD CELLS Other descriptive name: Red Blood Cell Concentrates (RBCs) Pro

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion Criteria for Registration (Step I) 1. Elderly patients (>= 70 years) 2. Undergoing intermediate- or high-risk non-cardiac surgery (according to the ESC/ESA Guidelines: surgery-related risk of cardiovascular death and myocardial infarction) a. Intermediate risk (30-day risk 1-5%): e.g., intraperitoneal (splenectomy, hiatal hernia), peripheral arterial angioplasty, endovascular aneurysm repair, head and neck, major neurological/orthopaedic (hip and spine), major urological, major gynaecological, intra-thoracic surgery b. High-risk (30-day risk > 5%): e.g., aortic and major vascular, open limb revascularisation, (partial) duodeno-pancreatic, (partial) liver resection, oesophagectomy, adrenal or (partial or radical) renal resection, total cystectomy 3. Written informed consent; obtained before surgery from the patients or from their legally authorised representative (authorisation including clinical research/clinical trials) / legal guardian, if the patient is unable to provide informed consent. Inclusion Criteria for Randomisation (Step II) Registered patients will be randomised only if and as soon as Hb falls 9 g/dl (even after a two-stage surgery) patient does not enter the main study but vital status (all-cause mortality) will be determined 90 days after surgery Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2470

Exclusion criteria

Exclusion criteria: Exclusion Criteria for Registration (Step I) 1. preoperative Hb level <= 9 g/dl 2. chronic kidney disease requiring dialysis 3. suspected lack of compliance with follow-up procedures 4. participation in other interventional trials 5. expected death within 3 months 6. inability to provide informed consent with absence of a legally authorised representative/ legal guardian 7. temporary inability to provide informed consent 8. previous participation in our trial 9. Patients who are prevented from having blood and blood products according to a system of beliefs (e.g. Jehovah’s Witnesses) 10. preoperative autologous blood donation Exclusion Criteria for Randomisation (Step II) 1. Occurrence of any component of composite endpoint after registration: - Acute myocardial infarction - Acute ischaemic stroke - Acute kidney injury (stage III) - Acute mesenteric ischaemia - Acute peripheral vascular ischaemia 2. Any allogeneic blood transfusion after registration

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate if in a geriatric population, a liberal strategy reduces the occurrence of major adverse events after non-cardiac surgery compared to a restrictive transfusion strategy within 90 days after surgery. The primary efficacy outcome is defined as a composite of: I. All-cause mortality defined as death from any cause II. Acute myocardial infarction confirmed by cardiologist III. Acute ischaemic stroke confirmed by neurologist IV. Acute kidney injury (stage III) defined according to the Kidney Disease Improving Global Outcomes criteria: Increase plasma creatinine level >= 3 times within 7 days or initiation of RRT V. Acute mesenteric ischaemia (ischaemia confirmed by intervention) VI. Acute peripheral vascular ischaemia defined as a new non-thrombotic compromised circulation in a limb confirmed by angiography and/or leading to surgery After hospital discharge, events of composite outcome will only be considered as present if they lead to hospital re-admission or death.;Secondary Objective: Liberal transfusion strategy: - reduces occurrence of any individual component of the composite of primary objectives at discharge and 90 days and 1 year after surgery - results in shorter total hospital stay and shorter LOS on ICU, improves functional status and health-related quality of life at 90 days after surgery - reduces the occurrence of acute kidney injury stage I-II defined according to the Kidney Disease Improving Global Outcomes criteria during the initial hospital stay - reduces Re-hospitalisation rate within 90 days after surgery - does not increase occurrence of infections 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 within 90 days after surgery. In addition, the proportion of patients receiving RBC transfusion and the number of units transfused are evaluated.;Primary end point(s):	—

Measure

Time frame

Main Objective: To evaluate if in a geriatric population, a liberal strategy reduces the occurrence of major adverse events after non-cardiac surgery compared to a restrictive transfusion strategy within 90 days after surgery. The primary efficacy outcome is defined as a composite of: I. All-cause mortality defined as death from any cause II. Acute myocardial infarction confirmed by cardiologist III. Acute ischaemic stroke confirmed by neurologist IV. Acute kidney injury (stage III) defined according to the Kidney Disease Improving Global Outcomes criteria: Increase plasma creatinine level >= 3 times within 7 days or initiation of RRT V. Acute mesenteric ischaemia (ischaemia confirmed by intervention) VI. Acute peripheral vascular ischaemia defined as a new non-thrombotic compromised circulation in a limb confirmed by angiography and/or leading to surgery After hospital discharge, events of composite outcome will only be considered as present if they lead to hospital re-admission or death.;Secondary Objective: Liberal transfusion strategy: - reduces occurrence of any individual component of the composite of primary objectives at discharge and 90 days and 1 year after surgery - results in shorter total hospital stay and shorter LOS on ICU, improves functional status and health-related quality of life at 90 days after surgery - reduces the occurrence of acute kidney injury stage I-II defined according to the Kidney Disease Improving Global Outcomes criteria during the initial hospital stay - reduces Re-hospitalisation rate within 90 days after surgery - does not increase occurrence of infections 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 within 90 days after surgery. In addition, the proportion of patients receiving RBC transfusion and the number of units transfused are evaluated.;Primary end point(s):

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Secondary

Measure	Time frame
Secondary end point(s): Secondary outcome measures are the following: - The occurrence of any individual component of the composite of all-cause mortality, acute myocardial infarction, acute stroke, acute kidney injury stage III, acute mesenteric ischaemia, and/or acute peripheral vascular ischaemia at hospital discharge, at 90 days, and 1 year after surgery. - The occurrence of any ischaemic event, i.e., acute myocardial infarction, acute stroke, acute kidney injury stage III, acute mesenteric ischaemia, and/or acute peripheral vascular ischaemia at hospital discharge, at 90 days, and 1 year after surgery, treating all-cause mortality as competing risk. - Proportion of patients receiving RBC transfusion and the number of units transfused. - Total length of stay in the intensive care unit and in hospital from randomisation to discharge (for strategy comparison); in addition, total length of stay in the intensive care unit and in hospital from admission to discharge will be used for descriptive purposes. - 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 - 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 within 90 days after surgery. - Time to (first) Re-hospitalisation within 90 days. - Functional status (assessed by Barthel Index by telephone questionnaire). - Health-related quality of life (assessed by EuroQoL EQ-5D and 12-item World Health Organisation Disability Assessment Schedule WHODAS 2.0) by telephone questionnaire). - Nutritional Risk Screening Sc	—

Measure

Time frame

Secondary end point(s): Secondary outcome measures are the following: - The occurrence of any individual component of the composite of all-cause mortality, acute myocardial infarction, acute stroke, acute kidney injury stage III, acute mesenteric ischaemia, and/or acute peripheral vascular ischaemia at hospital discharge, at 90 days, and 1 year after surgery. - The occurrence of any ischaemic event, i.e., acute myocardial infarction, acute stroke, acute kidney injury stage III, acute mesenteric ischaemia, and/or acute peripheral vascular ischaemia at hospital discharge, at 90 days, and 1 year after surgery, treating all-cause mortality as competing risk. - Proportion of patients receiving RBC transfusion and the number of units transfused. - Total length of stay in the intensive care unit and in hospital from randomisation to discharge (for strategy comparison); in addition, total length of stay in the intensive care unit and in hospital from admission to discharge will be used for descriptive purposes. - 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 - 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 within 90 days after surgery. - Time to (first) Re-hospitalisation within 90 days. - Functional status (assessed by Barthel Index by telephone questionnaire). - Health-related quality of life (assessed by EuroQoL EQ-5D and 12-item World Health Organisation Disability Assessment Schedule WHODAS 2.0) by telephone questionnaire). - Nutritional Risk Screening Sc

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Countries

Germany

Contacts

Public ContactPatrick Meybohm

University Hospital Wuerzburg, Department of Anaesthesiology

meybohm_p@ukw.de

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026