European Transfusion Practice and Outcome Study (ETPOS)

April 29, 2019 updated by: European Society of Anaesthesiology

European Transfusion Practice and Outcome Study A Multi-central Evaluation of Standard of Transfusion Care and Clinical Outcome for Elective Surgical Patients. Observational Study.

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.

Study Overview

Status

Completed

Conditions

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).)

Study Type

Observational

Enrollment (Actual)

6066

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Zagreb, Croatia
        • University hospital "Merkur"
  • Czechia
      • Brno, Czechia
        • Faculty hospital Brno
  • Estonia
      • Tallinn, Estonia
        • North Estonian Center
  • Germany
      • Tübingen, Germany
        • University Hospital Tübingen University, Germany
  • Greece
      • Athens, Greece
        • Aretaieion University Hospital
  • Israel
      • Tel Aviv, Israel
        • Tel Aviv Medical Center
  • Spain
      • Barcelona, Spain
        • Hospital Vall D Hebron
      • Valencia, Spain
        • Hospital Clínico Universitario de Valencia
  • Sweden
      • Göteborg, Sweden
        • Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients undergoing a non cardiothoracic, non emergency-trauma surgical procedure of participating hospital will be included, if they receive at least one pRBC. There are no further specific inclusion criteria. The only exclusion criteria will be age < 18 years and cardiothoracic and emergency trauma patients.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of PRBC and blood products and coagulation factors transfused
Time Frame: The 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
The Time point at which outcome measure is assessed is during surgery at Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Factors determining transfusion of PRBC and blood products in different regions of Europe
Time Frame: The 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
The Time point at which outcome measure is assessed is during surgery at Day 0
30-day mortality
Time Frame: The 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
The Time point at which outcome measure is assessed is at Day 30 after Surgery
Unplanned admission to the ICU
Time Frame: The 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
The Time point at which outcome measure is assessed is at Day 30 after Surgery
Type and frequency of usage of blood conserving techniques
Time Frame: The Time point at which outcome measure is assessed is at Day 0, on Surgery Day
The Time point at which outcome measure is assessed is at Day 0, on Surgery Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Society of Anaesthesiology

Investigators

  • Study Chair: Jens Meier, MD, General Hopsital Linz, Linz, Austria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

May 21, 2012

First Submitted That Met QC Criteria

May 21, 2012

First Posted (Estimate)

May 23, 2012

Study Record Updates

Last Update Posted (Actual)

May 1, 2019

Last Update Submitted That Met QC Criteria

April 29, 2019

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETPOS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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