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Liberale Transfusionsstrategie zur Prävention von Sterblichkeit und Anämie-assoziierten, ischämischen Ereignissen bei älteren, nicht-herzchirurgischen Patienten



Short title: LIBERAL-Trial

Investigated disease: perioperative anaemia

Principal Investigator: Prof. Dr. Sascha Treskatsch


Clinic, Institute: Klinik für Anästhesiologie m.S. operative Intensivmedizin CBF

Patient (diseased)
Age: 18 - 99
Gender: All

Status: Participants wanted
Last change: 23.09.2021

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Study Description

Title

Liberale Transfusionsstrategie zur Prävention von Sterblichkeit und Anämie-assoziierten, ischämischen Ereignissen bei älteren, nicht-herzchirurgischen Patienten

Short title

LIBERAL-Trial

General Short Description

There is no clear indication on when to administer a blood transfusion to patients older than 70 years old undergoing mid to high risk surgery. A blood transfusion is assioated with certain risk, and there must be a cllear indication for the administration of a transfusion. This study will address the question concerning the correct time to administer a transfusion as well as comparing a liberal apparoach to transfusion versus a more conservative approach.

Scientific Short Description

Perioperative anaemia leads to impaired oxygen supply with a risk of vital organ ischaemia, particularly of the heart, brain, kidney, and gut, resulting in perioperative myocardial ischaemia, stroke, kidney injury, and mesenteric ischaemia, respectively. In healthy and fit individuals, perioperative anaemia can be compensated by several mechanisms that preserve oxygen transport. Therefore, current guidelines recommend restrictive RBC transfusion after non-cardiac surgery.
Trials showing that restrictive transfusion is as safe as compared to a liberal strategy however typically including only a limited proportion of elderly patients. The compensatory mechanisms, however, are impaired in old and frail patients. Thus, it is unclear whether these guidelines apply in a geriatric population. Accordingly, major uncertainties exist among clinicians, and current clinical practice is variable. Noteworthy, clinicians have to deal with a large number of elderly non-cardiac surgical patients with significant perioperative anaemia and relevant need for RBC transfusion. More than 50% of all RBC transfusions are used in elderly patients in daily practice, and current population dynamics will lead to an increasing demand for RBC transfusions in the old-age patient group.

EudraCT-No.

2016-004446-29

Primary Register Type

ClinicalTrials.gov-No. (NCT)

Primary Register-ID

NCT03369210

Investigated Disease, Health Issue

ICD-Code
  • D50 - Eisenmangelanämie

perioperative Anämie

Inclusion Criteria

Age

18 - 99

Gender

All

Additional Inclusion Criteria

Patients ≥ 70 years of age scheduled for intermediate- or high-risk non-cardiac 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, 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

Characteristics

Studytype

Interventional

Studyphase

3

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