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| Name | Class |
|---|---|
| Wuerzburg University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liberal | Experimental | 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)). |
|
| Restrictive | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| red blood cell transfusion trigger | Drug | patients receive a RBC unit with different target ranges for the post-transfusion Hb levels |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Meybohm, MD | Wuerzburg University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Augsburg | Augsburg | Germany | ||||
| Berlin Charite CCM |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41114449 | Derived | Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6. | |
| 38780066 | Derived |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| 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 | 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) |
| 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 |
| Time to re-hospitalisation | Time to (first) re-hospitalisation | 90 days |
| functional status (Barthel index) | Functional status (assessed by Barthel Index) | 90 days |
| 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 |
| 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 |
| 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 | 97080 | Germany |
| Radford M, Estcourt LJ, Sirotich E, Pitre T, Britto J, Watson M, Brunskill SJ, Fergusson DA, Doree C, Arnold DM. Restrictive versus liberal red blood cell transfusion strategies for people with haematological malignancies treated with intensive chemotherapy or radiotherapy, or both, with or without haematopoietic stem cell support. Cochrane Database Syst Rev. 2024 May 23;5(5):CD011305. doi: 10.1002/14651858.CD011305.pub3. |
| 34932836 | Derived | 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. |
| 30717805 | Derived | 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. |