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

May 21, 2012
March 11, 2014
April 2013
October 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01604083 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
European Transfusion Practice and Outcome Study
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.

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).)
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

  • Surgery
  • Erythrocyte Transfusion
  • Habits
  • Anemia
  • Blood Coagulation Disorders
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6066
December 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Greece,   Czech Republic,   Spain,   Estonia,   Sweden,   Israel,   Croatia,   Germany
 
NCT01604083
ETPOS
No
European Society of Anaesthesiology
European Society of Anaesthesiology
Not Provided
Study Chair: Jens Meier, MD University Hospital Tübingen University, Germany
European Society of Anaesthesiology
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP