European Transfusion Practice and Outcome Study (ETPOS)
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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. |
- 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
- 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 ]
| Estimated Enrollment: | 10000 |
| Study Start Date: | April 2013 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
In European patients undergoing elective non-cardiac surgery receiving at least one PRBC(packed red blood cells) during their surgery it is proposed to:
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.
- Evaluate the ratio of transfusion of PRBC to blood products in the operating room
- 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
- 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 |
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.
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| Contact: Brigitte Leva | +3222109414 | research@esahq.org |
| Germany | |
| University Hospital Tübingen University, Germany | Not yet recruiting |
| Tübingen, Germany | |
| Contact: Jens Meier, MD | |
| Principal Investigator: Jens Meier, MD | |
| 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: | May 21, 2012 |
| Health Authority: | Germany: Ethics Commission Belgium: Ethics Committee |
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 Habits |
Hematologic Diseases Vascular Diseases Cardiovascular Diseases Hemorrhagic Disorders |
ClinicalTrials.gov processed this record on May 21, 2013