European Transfusion Practice and Outcome Study

Surgery Clinical Trial

— ETPOS  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01604083
• Other study ID #: ETPOS
• Status: Completed
• Start date: April 2013
• Est. completion date: December 2013

Study information

• Verified date: April 2016
• Source: European Society of Anaesthesiology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6066
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Blood Coagulation Disorders
• Erythrocyte Transfusion
• Habits
• Hemostatic Disorders
• Surgery

Locations

Country	Name	City	State
Croatia	University hospital "Merkur"	Zagreb
Czechia	Faculty Hospital Brno	Brno
Estonia	North Estonian Center	Tallinn
Germany	University Hospital Tübingen University, Germany	Tübingen
Greece	Aretaieion University Hospital	Athens
Israel	Tel Aviv Medical Center	Tel Aviv
Spain	Hospital Vall d Hebron	Barcelona
Spain	Hospital Clínico Universitario de Valencia	Valencia
Sweden	Sahlgrenska University Hospital	Göteborg

Sponsors (1)

Lead Sponsor	Collaborator
European Society of Anaesthesiology

Countries where clinical trial is conducted

Croatia,  Czechia,  Estonia,  Germany,  Greece,  Israel,  Spain,  Sweden, 

References & Publications (15)

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. doi: 10.1002/14651858.CD002042.pub3. Review. Update in: Cochrane Database Syst Rev. 2016 Oct 12;10 :CD002042. — View 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. — View 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. — View Citation

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. doi: 10.1001/jama.2010.1446. — View Citation

Hébert 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. — View Citation

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. — View 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. — View 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. Review. Erratum in: Crit Care Med. 2008 Nov;36(11):3134. — View 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. — View 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. — View 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. — View 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. Review. — View 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. Epub 2007 Sep 24. — View 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. — View 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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of PRBC and blood products and coagulation factors transfused	Amount of packed red blood cells and blood products and coagulation factors: fresh frozen plasmas (FFPs), platelets (PTs) and tranexamic acid transfused	The Time point at which outcome measure is assessed is during surgery at Day 0
Secondary	Factors determining transfusion of PRBC and blood products in different regions of Europe	Reasons for transfusion of PRBC(packed red blood cells)and blood products in different regions of Europe	The Time point at which outcome measure is assessed is during surgery at Day 0
Secondary	30-day mortality	Assesses on Day 30 whether patient is still alive or has died between day zero (Surgery) day 30 after surgery	The Time point at which outcome measure is assessed is at Day 30 after Surgery
Secondary	Unplanned admission to the ICU	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	The Time point at which outcome measure is assessed is at Day 30 after Surgery
Secondary	Type and frequency of usage of blood conserving techniques		The Time point at which outcome measure is assessed is at Day 0, on Surgery Day