European Transfusion Practice and Outcome Study - Full Text View

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:

MedlinePlus related topics: Anemia Bleeding Disorders Blood Transfusion and Donation

U.S. FDA Resources

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 ]

Estimated Enrollment:	10000
Study Start Date:	April 2013
Estimated Study Completion Date:	December 2013
Estimated 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:

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
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

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

Contacts

Contact: Brigitte Leva	+3222109414	research@esahq.org
Contact: Benoit Plichon		research@esahq.org

Locations

Croatia
University hospital "Merkur"	Recruiting
Zagreb, Croatia
Contact: Denis Gustin, M.D. denis.gustin@zg.t-com.hr
Principal Investigator: Denis Gustin, M.D.
Czech Republic
Faculty Hospital Brno	Recruiting
Brno, Czech Republic
Contact: Petr Stourac, M.D. petr.stourac@gmail.com
Principal Investigator: Petr Stourac, M.D.
Estonia
North Estonian Center	Recruiting
Tallinn, Estonia
Contact: Juri Oganjan, M.D.
Principal Investigator: Juri Oganjan, M.D
Germany
University Hospital Tübingen University, Germany	Not yet recruiting
Tübingen, Germany
Contact: Jens Meier, MD
Principal Investigator: Jens Meier, MD
Greece
Aretaieion University Hospital	Recruiting
Athens, Greece
Contact: Theodoraki Kassiani, M.D. ktheodoraki@hotmail.com
Principal Investigator: Theodoraki Kassiani
Israel
Tel Aviv Medical Center	Recruiting
Tel Aviv, Israel
Contact: Idit Matot, M.D. iditm@tlvmc.gov.il
Principal Investigator: Idit Matot, M.D.
Spain
Hospital Vall d Hebron	Recruiting
Barcelona, Spain
Contact: Montserrat Olivé molive@vhebron.net
Principal Investigator: Montserrat Olivé, M.D.
Hospital Clínico Universitario de Valencia	Recruiting
Valencia, Spain
Contact: Juan Vicente Llau Pitarch, M.D. juanvllau@gmail.com
Sweden
Sahlgrenska University Hospital	Recruiting
Göteborg, Sweden
Contact: Sören Söndergaard, M.D. soren.sondergaard@vgregion.se
Principal Investigator: Sören Söndergaard, M.D.

Sponsors and Collaborators

European Society of Anaesthesiology

Investigators

Study Chair:

Jens Meier, MD

University Hospital Tübingen University, Germany

More Information

Publications:

Carson JL, Carless PA, Hebert PC. Transfusion thresholds and other strategies for guiding allogeneic red blood cell transfusion. Cochrane Database Syst Rev. 2012 Apr 18;4:CD002042.

Corwin HL, Gettinger A, Pearl RG, Fink MP, Levy MM, Abraham E, MacIntyre NR, Shabot MM, Duh MS, Shapiro MJ. The CRIT Study: Anemia and blood transfusion in the critically ill--current clinical practice in the United States. Crit Care Med. 2004 Jan;32(1):39-52.

Gombotz H, Rehak PH, Shander A, Hofmann A. Blood use in elective surgery: the Austrian benchmark study. Transfusion. 2007 Aug;47(8):1468-80.

Hajjar LA, Vincent JL, Galas FR, Nakamura RE, Silva CM, Santos MH, Fukushima J, Kalil Filho R, Sierra DB, Lopes NH, Mauad T, Roquim AC, Sundin MR, Leão WC, Almeida JP, Pomerantzeff PM, Dallan LO, Jatene FB, Stolf NA, Auler JO Jr. Transfusion requirements after cardiac surgery: the TRACS randomized controlled trial. JAMA. 2010 Oct 13;304(14):1559-67.

Hsieh FY, Bloch DA, Larsen MD. A simple method of sample size calculation for linear and logistic regression. Stat Med. 1998 Jul 30;17(14):1623-34.

Hebert PC, Wells G, Blajchman MA, Marshall J, Martin C, Pagliarello G, Tweeddale M, Schweitzer I, Yetisir E. A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. Transfusion Requirements in Critical Care Investigators, Canadian Critical Care Trials Group. N Engl J Med. 1999 Feb 11;340(6):409-17. Erratum in: N Engl J Med 1999 Apr 1;340(13):1056.

Johansson PI, Bochsen L, Stensballe J, Secher NH. Transfusion packages for massively bleeding patients: the effect on clot formation and stability as evaluated by Thrombelastograph (TEG). Transfus Apher Sci. 2008 Aug;39(1):3-8. Epub 2008 Jun 25.

Marik PE, Corwin HL. Efficacy of red blood cell transfusion in the critically ill: a systematic review of the literature. Crit Care Med. 2008 Sep;36(9):2667-74. Review.

Netzer G, Liu X, Harris AD, Edelman BB, Hess JR, Shanholtz C, Murphy DJ, Terrin ML. Transfusion practice in the intensive care unit: a 10-year analysis. Transfusion. 2010 Oct;50(10):2125-34. doi: 10.1111/j.1537-2995.2010.02721.x.

Phan HH, Wisner DH. Should we increase the ratio of plasma/platelets to red blood cells in massive transfusion: what is the evidence? Vox Sang. 2010 Apr;98(3 Pt 2):395-402. Review.

Slonim AD, Joseph JG, Turenne WM, Sharangpani A, Luban NL. Blood transfusions in children: a multi-institutional analysis of practices and complications. Transfusion. 2008 Jan;48(1):73-80. Epub 2007 Sep 24.

Vincent JL, Baron JF, Reinhart K, Gattinoni L, Thijs L, Webb A, Meier-Hellmann A, Nollet G, Peres-Bota D; ABC (Anemia and Blood Transfusion in Critical Care) Investigators. Anemia and blood transfusion in critically ill patients. JAMA. 2002 Sep 25;288(12):1499-507.

Zink KA, Sambasivan CN, Holcomb JB, Chisholm G, Schreiber MA. A high ratio of plasma and platelets to packed red blood cells in the first 6 hours of massive transfusion improves outcomes in a large multicenter study. Am J Surg. 2009 May;197(5):565-70; discussion 570.

Meier J, Kozek-Langenecker S, Filipescu D, Pitarch JV, Mallett S, Martus P, Matot I. ESA Clinical Trials Network 2012: ETPOS--European Transfusion Practice and Outcome Study. Eur J Anaesthesiol. 2013 May;30(5):199-201. doi: 10.1097/EJA.0b013e32835f0052.

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 28, 2013
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
Habits

Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on June 17, 2013

European Transfusion Practice and Outcome Study (ETPOS)