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European Transfusion Practice and Outcome Study

Completed
Conditions
Surgery
Anemia
Habits
Blood Coagulation Disorders
Erythrocyte Transfusion
Registration Number
NCT01604083
Lead Sponsor
European Society of Anaesthesiology
Brief Summary

The aim of the ETPOS study is to describe differences in transfusion habits throughout Europe and to correlate these habits to perioperative outcome parameters. Special focus is put on the number of PRBCs (packed red blood cells) transfused and the ratio of PRBCs to other blood products or coagulation factors in the operating room. Furthermore the motivation of physicians to transfuse PRBC and blood products in the operating room will be investigated.

Detailed Description

In European patients undergoing elective non-cardiac surgery receiving at least one PRBC(packed red blood cells) during their surgery it is proposed to:

1. Evaluate evidence of differences in the standard of peri-operative transfusion care in different healthcare systems within Europe, and the use of blood conserving techniques.

1. Evaluate the ratio of transfusion of PRBC to blood products in the operating room

2. Evaluate which factors determine transfusion of PRBC (is it patient's haemodynamics / haemoglobin threshold/ pressure from the surgeon / acute brisk bleeding / else) and blood products (ratio to PRBC / POC (point of care) monitoring/ per protocol/ else) in the operating room

2. Evaluate whether there are factors in transfusion therapy that are associated with outcome (in-hospital mortality and unplanned admission to ICU(Intensive Care Unit).)

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
6066
Inclusion Criteria
  • patients undergoing elective non-cardiac surgery commencing during the three-month period and who received at least one erythrocyte concentrate during their intra-operative stay.
Exclusion Criteria
  • Age < 18 years
  • cardiothoracic surgery
  • emergency trauma patients

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Amount of PRBC and blood products and coagulation factors transfusedThe Time point at which outcome measure is assessed is during surgery at Day 0

Amount of packed red blood cells and blood products and coagulation factors: fresh frozen plasmas (FFPs), platelets (PTs) and tranexamic acid transfused

Secondary Outcome Measures
NameTimeMethod
Factors determining transfusion of PRBC and blood products in different regions of EuropeThe Time point at which outcome measure is assessed is during surgery at Day 0

Reasons for transfusion of PRBC(packed red blood cells)and blood products in different regions of Europe

30-day mortalityThe Time point at which outcome measure is assessed is at Day 30 after Surgery

Assesses on Day 30 whether patient is still alive or has died between day zero (Surgery) day 30 after surgery

Type and frequency of usage of blood conserving techniquesThe Time point at which outcome measure is assessed is at Day 0, on Surgery Day
Unplanned admission to the ICUThe Time point at which outcome measure is assessed is at Day 30 after Surgery

Assesses on day 30 whether the patient had a Unplanned admission to the Intensive care unit(ICU) following surgery (day 0) until the day 30

Trial Locations

Locations (9)

University hospital "Merkur"

🇭🇷

Zagreb, Croatia

Faculty Hospital Brno

🇨🇿

Brno, Czechia

Hospital Vall d Hebron

🇪🇸

Barcelona, Spain

Aretaieion University Hospital

🇬🇷

Athens, Greece

University Hospital Tübingen University, Germany

🇩🇪

Tübingen, Germany

Sahlgrenska University Hospital

🇸🇪

Göteborg, Sweden

Hospital Clínico Universitario de Valencia

🇪🇸

Valencia, Spain

Tel Aviv Medical Center

🇮🇱

Tel Aviv, Israel

North Estonian Center

🇪🇪

Tallinn, Estonia

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