European Transfusion Practice and Outcome Study (ETPOS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Society of Anaesthesiology
ClinicalTrials.gov Identifier:
NCT01604083
First received: May 21, 2012
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

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.


Condition
Surgery
Erythrocyte Transfusion
Habits
Anemia
Blood Coagulation Disorders

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: European Transfusion Practice and Outcome Study A Multi-central Evaluation of Standard of Transfusion Care and Clinical Outcome for Elective Surgical Patients. Observational Study.

Resource links provided by NLM:


Further study details as provided by European Society of Anaesthesiology:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    Reasons for transfusion of PRBC(packed red blood cells)and blood products in different regions of Europe

  • 30-day mortality [ Time Frame: The Time point at which outcome measure is assessed is at Day 30 after Surgery ] [ Designated as safety issue: No ]
    Assesses on Day 30 whether patient is still alive or has died between day zero (Surgery) 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]

Enrollment: 6066
Study Start Date: April 2013
Study Completion Date: December 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
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).)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01604083

Locations
Croatia
University hospital "Merkur"
Zagreb, Croatia
Czech Republic
Faculty Hospital Brno
Brno, Czech Republic
Estonia
North Estonian Center
Tallinn, Estonia
Germany
University Hospital Tübingen University, Germany
Tübingen, Germany
Greece
Aretaieion University Hospital
Athens, Greece
Israel
Tel Aviv Medical Center
Tel Aviv, Israel
Spain
Hospital Vall d Hebron
Barcelona, Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain
Sweden
Sahlgrenska University Hospital
Göteborg, Sweden
Sponsors and Collaborators
European Society of Anaesthesiology
Investigators
Study Chair: Jens Meier, MD University Hospital Tübingen University, Germany
  More Information

Publications:

Responsible Party: European Society of Anaesthesiology
ClinicalTrials.gov Identifier: NCT01604083     History of Changes
Other Study ID Numbers: ETPOS
Study First Received: May 21, 2012
Last Updated: March 11, 2014
Health Authority: Austria: Ethikkommission
Belgium: Ethics Committee
Croatia: Ethics Committee
Germany: Ethics Commission
Greece: Ethics Committee
Italy: Ethics Committee
Israel: Ethics Commission
Lithuania: Bioethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Portugal: Ethics Committee for Clinical Research
Romania: Ethics Committee
Russia: Ethics Committee
Serbia: Ethics Committee
Slovak Republic: Ethics Committee
Slovenia: Ethics Committee
Spain: Ethics Committee
Sweden: Regional Ethical Review Board
Turkey: Ethics Committee
United Kingdom: National Information Governance Board for Health and Social Care
United Kingdom: National Institute for Health Research

Keywords provided by European Society of Anaesthesiology:
transfusion
packed red blood cells (PRBC)
Transfusion Practice
Transfusion habits
Outcome
elective surgery
ETPOS
ESA
European Society of Anaesthesiology

Additional relevant MeSH terms:
Anemia
Blood Coagulation Disorders
Hemostatic Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on August 18, 2014