Clinical trial NCT01604083: European Transfusion Practice and Outcome Study
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Erythrocyte Transfusion
Habits
Anemia
Blood Coagulation Disorders
Keywords: transfusion
packed red blood cells (PRBC)
Transfusion Practice
Transfusion habits
Outcome
elective surgery
ETPOS
ESA
European Society of Anaesthesiology
Lead sponsor: European Society of Anaesthesiology
Sponsor class: OTHER
First posted: 2012-05-23
Enrollment: 6066
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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 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

Primary outcomes:
measure: Amount of PRBC and blood products and coagulation factors transfused
timeFrame: The Time point at which outcome measure is assessed is during surgery at Day 0
Secondary outcomes:
measure: Factors determining transfusion of PRBC and blood products in different regions of Europe
timeFrame: The Time point at which outcome measure is assessed is during surgery at Day 0
measure: 30-day mortality
timeFrame: The Time point at which outcome measure is assessed is at Day 30 after Surgery
measure: Unplanned admission to the ICU
timeFrame: The Time point at which outcome measure is assessed is at Day 30 after Surgery
measure: Type and frequency of usage of blood conserving techniques
timeFrame: The Time point at which outcome measure is assessed is at Day 0, on Surgery Day
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University hospital "Merkur"
city: Brno
country: Czechia
facility: Faculty Hospital Brno
city: Tallinn
country: Estonia
facility: North Estonian Center
city: Tübingen
country: Germany
facility: University Hospital Tübingen University, Germany
city: Athens
country: Greece
facility: Aretaieion University Hospital
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center
city: Barcelona
country: Spain
facility: Hospital Vall d Hebron
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: General Hopsital Linz, Linz, Austria
name: Jens Meier, MD
role: STUDY_CHAIR
References:
citation: 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(4):CD002042. doi: 10.1002/14651858.CD002042.pub3.
citation: 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. doi: 10.1097/01.CCM.0000104112.34142.79.
citation: Gombotz H, Rehak PH, Shander A, Hofmann A. Blood use in elective surgery: the Austrian benchmark study. Transfusion. 2007 Aug;47(8):1468-80. doi: 10.1111/j.1537-2995.2007.01286.x.
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citation: 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. doi: 10.1056/NEJM199902113400601.
citation: 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. doi: 10.1016/j.transci.2008.05.012. Epub 2008 Jun 25.
citation: 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. doi: 10.1097/CCM.0b013e3181844677.
citation: 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.
citation: 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. doi: 10.1111/j.1423-0410.2009.01265.x.
citation: 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. doi: 10.1111/j.1537-2995.2007.01484.x. Epub 2007 Sep 24.
citation: 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. doi: 10.1001/jama.288.12.1499.
citation: 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. doi: 10.1016/j.amjsurg.2008.12.014.
citation: 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. No abstract available.
citation: Meier J, Filipescu D, Kozek-Langenecker S, Llau Pitarch J, Mallett S, Martus P, Matot I; ETPOS collaborators. Intraoperative transfusion practices in Europe. Br J Anaesth. 2016 Feb;116(2):255-61. doi: 10.1093/bja/aev456.