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



Kurztitel: LIBERAL-Trial

Untersuchte Krankheit: perioperative anaemia

Studienleitung: Prof. Dr. Sascha Treskatsch


Klinik, Institut: Klinik für Anästhesiologie m.S. operative Intensivmedizin CBF

Patient/-in (krank)
Alter: 18 - 99
Geschlecht: Alle

Status: Teilnehmende gesucht
Stand: 29.07.2021

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Studienbeschreibung

Titel

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

Kurztitel

LIBERAL-Trial

Allgemeinverständliche Kurzbeschreibung

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.

Wissenschaftliche Kurzbeschreibung

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-Nr.

2016-004446-29

Primärregister-Typ

ClinicalTrials.gov-Nr (NCT)

Primärregister-ID

NCT03369210

Untersuchte Krankheit, Gesundheitsproblem

ICD-Code
  • D50 - Eisenmangelanämie

perioperative Anämie

Einschlusskriterien

Alter

18 - 99

Geschlecht

Alle

Weitere Einschlusskriterien

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

Ausschlusskriterien

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

Charakteristika

Studientyp

Interventionell

Studienphase

III

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