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SurgeryETPOSNCT01604083

European Transfusion Practice and Outcome Study

An observational study of Surgery and Erythrocyte Transfusion, run by European Society of Anaesthesiology at 9 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Surgery, Erythrocyte Transfusion, Habits
How many people
6,066 participants
Where
9 sitesin 8 countries
Study dates
Apr 2013to Dec 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

9 sites in 8 countries.

9 sites in 8 countries

Spain2 sites

  • Hospital Vall d Hebron

    Barcelona

  • Hospital Clínico Universitario de Valencia

    Valencia

Other trials in Spain

Croatia1 site

  • University hospital "Merkur"

    Zagreb

Other trials in Croatia

Czechia1 site

  • Faculty Hospital Brno

    Brno

Other trials in Czechia

Estonia1 site

  • North Estonian Center

    Tallinn

Other trials in Estonia

Germany1 site

  • University Hospital Tübingen University, Germany

    Tübingen

Other trials in Germany

Greece1 site

  • Aretaieion University Hospital

    Athens

Other trials in Greece

Israel1 site

  • Tel Aviv Medical Center

    Tel Aviv

Other trials in Israel

Sweden1 site

  • Sahlgrenska University Hospital

    Gothenburg

Other trials in Sweden

About this 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.

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.

Read the 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.
  2. Evaluate the ratio of transfusion of PRBC to blood products in the operating room
  3. 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
  4. Evaluate whether there are factors in transfusion therapy that are associated with outcome (in-hospital mortality and unplanned admission to ICU(Intensive Care Unit).)
Keywords
transfusion, packed red blood cells (PRBC), Transfusion Practice, Transfusion habits, Outcome, elective surgery, ETPOS, ESA, European Society of Anaesthesiology
Medical subject headings
Habits, Anemia, Blood Coagulation Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (4)

  1. 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

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

  2. 30-day mortality

    Assesses on Day 30 whether patient is still alive or has died between day zero (Surgery) day 30 after surgery

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

  3. 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

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

  4. Type and frequency of usage of blood conserving techniques

    Measured: The Time point at which outcome measure is assessed is at Day 0, on Surgery Day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2012 (estimated)
  2. Study startApr 2013
  3. Primary completionOct 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
6,066 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01604083
Sponsor's protocol ID
ETPOS
Acronym
ETPOS
Status last verified
Apr 2016
First submitted
21 May 2012
Last updated
1 May 2019
Results posted
No
Data monitoring committee
No

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

    PubMed 22513904

  • 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.

    PubMed 14707558

  • 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.

    PubMed 17655591

  • 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.

    PubMed 20940381

  • 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.

    PubMed 9699234

  • 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.

    PubMed 9971864

  • 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.

    PubMed 18583193

  • 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.

    PubMed 18679112

  • 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.

    PubMed 20553436

  • 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.

    PubMed 20432517

  • 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.

    PubMed 17894792

  • 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.

    PubMed 12243637

  • 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.

    PubMed 19393349

  • 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.

    PubMed 23571430

  • 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.

    PubMed 26787795

Questions about this trial

What is this clinical trial studying?

An observational study of Surgery and Erythrocyte Transfusion, run by European Society of Anaesthesiology at 9 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Spain, Croatia, Czechia, Estonia, Germany and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01604083, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019.

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European Transfusion Practice and Outcome Study | AzTrials