NCT01604083

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,066

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2013

Shorter than P25 for all trials

Geographic Reach
7 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2012

Completed
10 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

May 1, 2019

Status Verified

April 1, 2016

Enrollment Period

6 months

First QC Date

May 21, 2012

Last Update Submit

April 29, 2019

Conditions

SurgeryErythrocyte TransfusionHabitsAnemiaBlood Coagulation Disorders

Keywords

transfusionpacked red blood cells (PRBC)Transfusion PracticeTransfusion habitsOutcomeelective surgeryETPOSESAEuropean Society of Anaesthesiology

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Factors determining transfusion of PRBC and blood products in different regions of Europe

    The Time point at which outcome measure is assessed is during surgery at Day 0

  • 30-day mortality

    The Time point at which outcome measure is assessed is at Day 30 after Surgery

  • Unplanned admission to the ICU

    The Time point at which outcome measure is assessed is at Day 30 after Surgery

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • \- 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.

You may not qualify if:

  • Age \< 18 years
  • cardiothoracic surgery
  • emergency trauma patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

University hospital "Merkur"

Zagreb, Croatia

Location

Faculty Hospital Brno

Brno, Czechia

Location

North Estonian Center

Tallinn, Estonia

Location

University Hospital Tübingen University, Germany

Tübingen, Germany

Location

Aretaieion University Hospital

Athens, Greece

Location

Tel Aviv Medical Center

Tel Aviv, Israel

Location

Hospital Vall d Hebron

Barcelona, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, Spain

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Related 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(4):CD002042. doi: 10.1002/14651858.CD002042.pub3.

    PMID: 22513904BACKGROUND

  • 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.

    PMID: 14707558BACKGROUND

  • 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.

    PMID: 17655591BACKGROUND

  • 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, Leao 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.

    PMID: 20940381BACKGROUND

  • 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. doi: 10.1002/(sici)1097-0258(19980730)17:143.0.co;2-s.

    PMID: 9699234BACKGROUND

  • 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.

    PMID: 9971864BACKGROUND

  • 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.

    PMID: 18583193BACKGROUND

  • 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.

    PMID: 18679112BACKGROUND

  • 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.

    PMID: 20553436BACKGROUND

  • 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.

    PMID: 20432517BACKGROUND

  • 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.

    PMID: 17894792BACKGROUND

  • 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.

    PMID: 12243637BACKGROUND

  • 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.

    PMID: 19393349BACKGROUND

  • 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.

    PMID: 23571430BACKGROUND

  • 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.

    PMID: 26787795RESULT

MeSH Terms

Conditions

HabitsAnemiaBlood Coagulation Disorders

Condition Hierarchy (Ancestors)

BehaviorHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Jens Meier, MD

    General Hopsital Linz, Linz, Austria

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2012

First Posted

May 23, 2012

Study Start

April 1, 2013

Primary Completion

October 1, 2013

Study Completion

December 1, 2013

Last Updated

May 1, 2019

Record last verified: 2016-04

Locations

GR(1)CR(1)IL(1)ES(2)SE(1)DE(1)CZ(1)