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AnemiaCEEPBMNCT06878105

Patient Blood Management Implementation in CEE Study

An observational study of Anemia and Coagulopathy, run by Semmelweis University at 1 site in Hungary.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of the study is data collection on available fixed and personal assets required for Patient Blood Management (elements of the 3 pillars of PBM) in Central Eastern Europe countries hospitals, status before and after PBM training. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anemia, Coagulopathy
What is being tested?
Data collection on interventions performs as per medical routine
How many people
2,000 participants
Where
1 siteHungary
Study dates
27 May 2024to 31 Dec 2025
Phase
Observational
Are there results?
Not yet: the study is under way

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
  • Adult, Older adult

Study population: Patients undergoing elective surgerical interventions with medium or high bleeding risk during predefined two times one week periods - one week at basline and one week after 6 months

Who may be able to join

  • patients above 18 years of age
  • patients undergoing elective medium and high bleeding risk surgical intervention defined as moderate (<500 ml) and high (≥ 500 ml)
  • patient consent

Who cannot join

  • no patient consent
  • patients under 18 years of age
  • pregnant patients
  • surgery with a low risk of bleeding
  • the patient underwent emergency (non-elective) surgery

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

János Fazakas, Ass Prof contact

+36208258560

jancsidora@gmail.com

Anikó Smudla, MD contact

+36304362384

aniko_smudla@yahoo.com

Hungary1 site, 1 recruiting
  • Semmelweis University

    Budapest, 1085

    János Fazakas, Ass. Prof., +36208258560, jancsidora@gmail.com

    Aniko Smudla, +36304362384, aniko_smudla@yahoo.com

    Recruiting

Other trials in Hungary

About this study

Official title: Evaluation of Fixed and Personal Assets for Patient Blood Management Implementation in CEE Countries in Practice

The goal of the study is data collection on available fixed and personal assets required for Patient Blood Management (elements of the 3 pillars of PBM) in Central Eastern Europe countries hospitals, status before and after PBM training.

Read the detailed description

The goals of the PBM program:

  • Improving patient care and optimizing blood management - quality assurance
  • bleeding management based on latest scientific guidelines including:
  1. reduction of transfusion and better outcomes
  2. optimization of blood reserves
  3. introduction and acceptance of hospital protocols Previous research has identified gaps concerning implementation of PBM elements in CEE region calling for further research and training: anemia is not being managed appropriately, there are no protocols in place, patient journey is not clearly defined, it is not clear at which department should be anemia treated; availability of POC devices varies largely among countries; local protocols for management of severe bleeding are also missing in many hospitals.

Investigators plan to collect PBM implementation indicators in hospitals before PBM training at a given start point as baseline (first self audit) and re-evaluate achievements after 6 months after training (second self audit).

Investigators plan to define 2x1 week "snapshot" period for detailed analysis of perioperative approach at patient level (1 week at the beginning of the study and 1 week after 6 month).

Investigators assume that properly conducted self-audits followed by PBM training, optimizing local protocols and patient journeys, a reduction in the use of perioperative blood products may be achieved, which, in addition to the currently experienced decrease in the desire to donate blood, may lead to a more rational blood product management and better patient outcomes.

PBM Implementation indicators for hospitals (data to be collected):

  • PBM administration \& training data - are there PBM managers/local protocols available? was there any PBM training of staff performed?
  • Pilar I.: data about diagnosis and management of anemia; patient pathways; medications used to treat anemia
  • Pilar II.: blood saving techniques; usage of blood products (transfusion) and/or factor concentrates; iatrogenic blood loss - lab test tubes size
  • Pilar III.: RBC tranfusion triggers;

Patient level data:

  • age, gender, type of surgical intervention
  • data about anemia management (performed or not by whom, when and what treatment was received if any
  • data about existing anticoagulant therapy an management
  • data about bleeding management (blood loss, transfusion requirements, factor concentrates (used quantities per routine medical intervention), POC tests evaluations if any, and standard laboratory test performed per routine medical approach before, during and after surgery
  • data about postoperative outcomes
Conditions
Anemia, Coagulopathy
Being tested
Data collection on interventions performs as per medical routine
Medical subject headings
Anemia, Hemostatic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Data collection on interventions performs as per medical routineOther

    No intervention other than routine medical practice

Study groups in NCT06878105
Study groupRoleWhat they receive
Hospital self audit data baseline before PBM trainingAnticipated 50 hospitals from Hungary, Romania, Czech Republic, Slovakia, Croatia, Austria. Only data about drugs/blood products used as medical routine will be recorded - no evaluation of any drug effect/efficacy.
Receives: Other: Data collection on interventions performs as per medical routine
Hospital self audit data after 6 month after PBM trainingAnticipated 50 hospitals from Hungary, Romania, Czech Republic, Slovakia, Croatia, Austria.Only data about drugs/blood products used as medical routine will be recorded - no evaluation of any drug effect/efficacy.
Receives: Other: Data collection on interventions performs as per medical routine

What is being measured

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

  1. Was the PBM training able to significantly reduce the use of blood products in the audited periods?

    Identification of local and country level PBM gaps during the first self audit followed by training and corrective measures, reidentification of remaining local and country level PBM gaps during the second self audit:

    1. Reduction of RBC, FFP and TC in Units
    2. PBM trained physichian in number

    Measured: second self audit versus first self audit ( 6 months)

Secondary outcomes (5)
  1. Material assets for the PBM pillars

    1. increase in use of POC tests (number of tests)
    2. increase in use of factor concentrates (IU)
    3. local hemostasis management protocols (YES/NO)

    Measured: second self audit versus first self audit ( 6 months)

  2. Impact of PBM implementation on postoperative care

    Time spent in the intensive care unit in the postoperative period (ICU days)

    Measured: second self audit versus first self audit ( 6 months)

  3. Impact of PBM implementation on postoperative care

    Hospital length of stay (days)

    Measured: second self audit versus first self audit ( 9 months)

  4. PBM implementation impact on infection rates

    Postoperative infection rate

    Measured: second self audit versus first self audit ( 6 months)

  5. PBM implemetnation impact on mortality

    30 days mortality

    Measured: second self audit versus first self audit ( 6 months)

Timeline

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

  1. First posted14 Mar 2025
  2. Study start27 May 2024
  3. Primary completion30 Sep 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

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
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06878105
Sponsor's protocol ID
CG90142103
Acronym
CEEPBM
Status last verified
Mar 2025
First submitted
2 Aug 2024
Last updated
14 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Uden H, Buttner F, von Heymann C, Kramer M, Kaufner L, Vorderwulbecke G, Hardt S, Kruppa J, Balzer F, Spies C. Allogeneic Blood Transfusion and Risk of Postoperative Complications in Patients with Mild and Moderate Anemia of Any Cause? A Retrospective Cohort Study in Total Revision Hip Surgery. Transfus Med Hemother. 2023 Jul 12;51(1):12-21. doi: 10.1159/000530135. eCollection 2024 Feb.

    PubMed 38314244
  • Meybohm P, Schmitt E, Choorapoikayil S, Hof L, Old O, Muller MM, Geisen C, Seifried E, Baumhove O, de Leeuw van Weenen S, Bayer A, Friederich P, Brautigam B, Friedrich J, Gruenewald M, Elke G, Molter GP, Narita D, Raadts A, Haas C, Schwendner K, Steinbicker AU, Jenke DJ, Thoma J, Weber V, Velten M, Wittmann M, Weigt H, Lange B, Herrmann E, Zacharowski K; German Patient Blood Management Network Collaborators. German Patient Blood Management Network: effectiveness and safety analysis in 1.2 million patients. Br J Anaesth. 2023 Sep;131(3):472-481. doi: 10.1016/j.bja.2023.05.006. Epub 2023 Jun 26.

    PubMed 37380568
  • Mitra B, Jorgensen M, Reade MC, Keegan A, Holley A, Farmer S, Harvey N, Winearls J, Parr M, French CJ; Clinical and Consumer Reference group for the update of Patient Blood Management Guidelines (Module 1: Critical Bleeding/Massive Transfusion). Patient blood management guideline for adults with critical bleeding. Med J Aust. 2024 Mar 4;220(4):211-216. doi: 10.5694/mja2.52212. Epub 2024 Jan 28.

    PubMed 38282333
  • Babik B, Fazakas J, Matusovits A, Gal J, Fulesdi B. [Perioperative Patient Blood Management: common risk, common tasks, common responsibility]. Orv Hetil. 2020 Sep;161(37):1545-1553. doi: 10.1556/650.2020.31918. Hungarian.

    PubMed 32894734
  • Olah Z, Fulesdi B, Gal J, Matusovits A, Babik B. [Principles of the perioperative Patient Blood Management]. Orv Hetil. 2020 Sep;161(37):1554-1568. doi: 10.1556/650.2020.31787. Hungarian.

    PubMed 32894735
  • Delaforce A, Duff J, Munday J, Hardy J. Preoperative Anemia and Iron Deficiency Screening, Evaluation and Management: Barrier Identification and Implementation Strategy Mapping. J Multidiscip Healthc. 2020 Dec 1;13:1759-1770. doi: 10.2147/JMDH.S282308. eCollection 2020.

    PubMed 33293819
  • Farmer SL, Towler SC, Leahy MF, Hofmann A. Drivers for change: Western Australia Patient Blood Management Program (WA PBMP), World Health Assembly (WHA) and Advisory Committee on Blood Safety and Availability (ACBSA). Best Pract Res Clin Anaesthesiol. 2013 Mar;27(1):43-58. doi: 10.1016/j.bpa.2012.12.007.

    PubMed 23590915
  • Hofmann A, Spahn DR, Holtorf AP; PBM Implementation Group. Making patient blood management the new norm(al) as experienced by implementors in diverse countries. BMC Health Serv Res. 2021 Jul 2;21(1):634. doi: 10.1186/s12913-021-06484-3.

    PubMed 34215251
  • Kietaibl S, Ahmed A, Afshari A, Albaladejo P, Aldecoa C, Barauskas G, De Robertis E, Faraoni D, Filipescu DC, Fries D, Godier A, Haas T, Jacob M, Lance MD, Llau JV, Meier J, Molnar Z, Mora L, Rahe-Meyer N, Samama CM, Scarlatescu E, Schlimp C, Wikkelso AJ, Zacharowski K. Management of severe peri-operative bleeding: Guidelines from the European Society of Anaesthesiology and Intensive Care: Second update 2022. Eur J Anaesthesiol. 2023 Apr 1;40(4):226-304. doi: 10.1097/EJA.0000000000001803.

    PubMed 36855941
  • Musallam KM, Tamim HM, Richards T, Spahn DR, Rosendaal FR, Habbal A, Khreiss M, Dahdaleh FS, Khavandi K, Sfeir PM, Soweid A, Hoballah JJ, Taher AT, Jamali FR. Preoperative anaemia and postoperative outcomes in non-cardiac surgery: a retrospective cohort study. Lancet. 2011 Oct 15;378(9800):1396-407. doi: 10.1016/S0140-6736(11)61381-0. Epub 2011 Oct 5.

    PubMed 21982521
  • Yan T, Lei S, Zhou B, Huang Y, Li X, Zhang J, Huang Q, Zhang L. Association between preoperative anemia and postoperative short-term outcomes in patients undergoing colorectal cancer surgery - a propensity score matched retrospective cohort study. BMC Anesthesiol. 2023 Sep 11;23(1):307. doi: 10.1186/s12871-023-02270-2.

    PubMed 37697231

Questions about this trial

What is this clinical trial studying?

An observational study of Anemia and Coagulopathy, run by Semmelweis University at 1 site in Hungary.

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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hungary. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact János Fazakas, Ass Prof (+36208258560, jancsidora@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Was the PBM training able to significantly reduce the use of blood products in the audited periods? (time frame: second self audit versus first self audit ( 6 months)). 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 NCT06878105, which also lists 11 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 14 Mar 2025.

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