LIBERAL: Liberal Transfusion Strategy in Elderly Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Liberal 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)). |
Drug: red blood cell transfusion trigger
patients receive a RBC unit with different target ranges for the post-transfusion Hb levels
|
| Active Comparator: Restrictive 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). |
Drug: red blood cell transfusion trigger
patients receive a RBC unit with different target ranges for the post-transfusion Hb levels
|
Outcome Measures
Primary Outcome Measures
- Occurrence of a composite endpoint [90 days]
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.
Secondary Outcome Measures
- Proportion of patients receiving red blood cell transfusion [hospital discharge (an anticipated average of 10 days)]
- Number of red blood cell units transfused [hospital discharge (an anticipated average of 10 days)]
- Total length of stay in the intensive care unit [hospital discharge (an anticipated average of 10 days)]
- Total length of stay in hospital [hospital discharge (an anticipated average of 10 days)]
- Number of participants with acute kidney injury stage I-II [hospital discharge (an anticipated average of 10 days)]
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 infection [90 days]
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
- Time to re-hospitalisation [90 days]
Time to (first) re-hospitalisation
- functional status (Barthel index) [90 days]
Functional status (assessed by Barthel Index)
- Health-related quality of life [90 days]
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)
- Occurrence of any individual component of the composite [1 year]
composite components (all-cause mortality, acute myocardial infarction, acute stroke, acute kidney injury stage III, acute mesenteric ischaemia, and/or acute peripheral vascular ischaemia)
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | RWTH Aachen | Aachen | Germany | ||
| 2 | Charite Berlin | Berlin | Germany | ||
| 3 | University Hospital Düsseldorf | Düsseldorf | Germany | ||
| 4 | University Hospital Frankfurt | Frankfurt | Germany | ||
| 5 | Justus-Liebig-Universität Giessen | Gießen | Germany | ||
| 6 | University Hospital Greifswald | Greifswald | Germany | ||
| 7 | University Hospital Schleswig-Holstein, Campus Lübeck | Lübeck | Germany | ||
| 8 | University Hospital Münster | Münster | Germany | ||
| 9 | University Hospital Würzburg | Würzburg | Germany |
Sponsors and Collaborators
- Dr. Patrick Meybohm, M.D.
Investigators
- Principal Investigator: Patrick Meybohm, MD, University Hospital Frankfurt
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 139/17F