Clinical trial NCT03369210: Liberal Transfusion Strategy in Elderly Patients
Official title: Liberal Transfusion Strategy to Prevent Mortality and Anaemia-associated, Ischaemic Events in Elderly Non-cardiac Surgical Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Transfusion-dependent Anemia
Surgery
Anemia
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
Collaborators: name: Wuerzburg University Hospital
First posted: 2017-12-11
Enrollment: 2470
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Occurrence of a composite endpoint
timeFrame: 90 days
Secondary outcomes:
measure: Proportion of patients receiving red blood cell transfusion
timeFrame: hospital discharge (an anticipated average of 10 days)
measure: Number of red blood cell units transfused
timeFrame: hospital discharge (an anticipated average of 10 days)
measure: Total length of stay in the intensive care unit
timeFrame: hospital discharge (an anticipated average of 10 days)
measure: Total length of stay in hospital
timeFrame: hospital discharge (an anticipated average of 10 days)
measure: Number of participants with acute kidney injury stage I-II
timeFrame: hospital discharge (an anticipated average of 10 days)
measure: Time to infection
timeFrame: 90 days
measure: Time to re-hospitalisation
timeFrame: 90 days
measure: functional status (Barthel index)
timeFrame: 90 days
measure: Health-related quality of life
timeFrame: 90 days
measure: Occurrence of any individual component of the composite
timeFrame: 1 year
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: University Hospital Augsburg
city: Berlin
country: Germany
facility: Berlin Charite CCM
city: Berlin
country: Germany
facility: Charite Berlin CBF
city: Bonn
country: Germany
facility: University Hospital Bonn
city: Dortmund
country: Germany
facility: Klinikum Dortmund
city: Frankfurt
country: Germany
facility: University Hospital Frankfurt
city: Hamburg
country: Germany
facility: University Hospital Hamburg
city: Jena
country: Germany
facility: University Hospital Jena
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein
city: Mainz
country: Germany
facility: University Hospital Mainz
city: Münster
country: Germany
facility: St. Franziskus Hospital Münster
city: Münster
country: Germany
facility: University Hospital Münster
city: Regensburg
country: Germany
facility: University Hospital Regensburg
city: Würzburg
country: Germany
facility: University Hospital Würzburg
Study officials:
affiliation: Wuerzburg University Hospital
name: Patrick Meybohm, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.