Transfusion strategies for elderly patients undergoing surgery

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

This study tests if giving more or fewer blood transfusions to older patients having surgery can affect their recovery and overall health after the operation.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2470 (estimated)
• Ages: 70 Years and up
• Sex: All
• Sponsor: Johann Wolfgang Goethe University Hospital (Academic / other)
• Locations: 14 sites (Augsburg and 13 other locations)
• Trial ID: NCT03369210 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of different red blood cell transfusion strategies in elderly patients aged 70 and older who are undergoing intermediate- or high-risk non-cardiac surgery. Participants will be randomly assigned to either a liberal transfusion group, where they receive transfusions when hemoglobin levels fall to 9 g/dl or lower, or a restrictive group, where transfusions are given only when levels drop to 7.5 g/dl or lower. The primary goal is to assess the impact of these strategies on mortality and anemia-related ischemic events within 90 days post-surgery.

Who should consider this trial

Good fit: Ideal candidates are elderly patients aged 70 and older scheduled for intermediate- or high-risk non-cardiac surgery.

Not a fit: Patients with preoperative hemoglobin levels of 9 g/dl or lower, chronic kidney disease requiring dialysis, or those unable to provide informed consent may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could optimize transfusion practices, potentially improving outcomes for elderly surgical patients.

How similar studies have performed: Other studies have explored transfusion strategies in various populations, but this specific approach in elderly surgical patients is relatively novel.

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.

Where this trial is running

Augsburg and 13 other locations

• University Hospital Augsburg — Augsburg, Germany (Recruiting)
• Berlin Charite CCM — Berlin, Germany (Recruiting)
• Charite Berlin CBF — Berlin, Germany (Recruiting)
• University Hospital Bonn — Bonn, Germany (Recruiting)
• Klinikum Dortmund — Dortmund, Germany (Not_yet_recruiting)
• University Hospital Frankfurt — Frankfurt, Germany (Recruiting)
• University Hospital Hamburg — Hamburg, Germany (Recruiting)
• University Hospital Jena — Jena, Germany (Recruiting)
• University Hospital Schleswig-Holstein — Kiel, Germany (Recruiting)
• University Hospital Mainz — Mainz, Germany (Recruiting)
• St. Franziskus Hospital Münster — Münster, Germany (Recruiting)
• University Hospital Münster — Münster, Germany (Recruiting)
• University Hospital Regensburg — Regensburg, Germany (Recruiting)
• University Hospital Würzburg — Würzburg, Germany (Recruiting)

Study contacts

• Principal investigator: Patrick Meybohm, MD — Wuerzburg University Hospital
• Study coordinator: Patrick Meybohm, MD

Conditions Transfusion-dependent Anemia; Surgery; Anemia