Status:
ACTIVE_NOT_RECRUITING
Liberal Transfusion Strategy in Elderly Patients
Lead Sponsor:
Johann Wolfgang Goethe University Hospital
Collaborating Sponsors:
Wuerzburg University Hospital
Conditions:
Transfusion-dependent Anemia
Surgery
Eligibility:
All Genders
70+ years
Phase:
PHASE3
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 lib...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
2470 Patients enrolled
Trial Details
Trial ID
NCT03369210
Start Date
December 4 2017
End Date
July 31 2026
Last Update
August 7 2025
Active Locations (14)
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1
University Hospital Augsburg
Augsburg, Germany
2
Berlin Charite CCM
Berlin, Germany
3
Charite Berlin CBF
Berlin, Germany
4
University Hospital Bonn
Bonn, Germany