Liberal Transfusion Strategy in Elderly Patients

Surgery Clinical Trial

— LIBERAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03369210
• Other study ID #: 139/17F
• Status: Recruiting
• Phase: Phase 3
• Start date: December 4, 2017
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Johann Wolfgang Goethe University Hospital
• Contact: Patrick Meybohm, MD
• Phone: 004993120130001
• Email: meybohm_p[@]ukw.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2470
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Surgery
• Transfusion-dependent Anemia

Intervention

Drug:
• red blood cell transfusion trigger
patients receive a RBC unit with different target ranges for the post-transfusion Hb levels

Locations

Country	Name	City	State
Germany	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

Sponsors (2)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospital	Wuerzburg University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of patients receiving red blood cell transfusion		hospital discharge (an anticipated average of 10 days)
Secondary	Number of red blood cell units transfused		hospital discharge (an anticipated average of 10 days)
Secondary	Total length of stay in the intensive care unit		hospital discharge (an anticipated average of 10 days)
Secondary	Total length of stay in hospital		hospital discharge (an anticipated average of 10 days)
Secondary	Number of participants with acute kidney injury stage I-II	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	hospital discharge (an anticipated average of 10 days)
Secondary	Time to infection	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	90 days
Secondary	Time to re-hospitalisation	Time to (first) re-hospitalisation	90 days
Secondary	functional status (Barthel index)	Functional status (assessed by Barthel Index)	90 days
Secondary	Health-related quality of life	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)	90 days
Secondary	Occurrence of any individual component of the composite	composite components (all-cause mortality, acute myocardial infarction, acute stroke, acute kidney injury stage III, acute mesenteric ischaemia, and/or acute peripheral vascular ischaemia)	1 year

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