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NCT Number: NCT06878105

Patient Blood Management Implementation in CEE Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

The goals of the PBM program:

  • Improving patient care and optimizing blood management - quality assurance
  • bleeding management based on latest scientific guidelines including:
  • reduction of transfusion and better outcomes
  • optimization of blood reserves
  • 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

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Data collection on interventions performs as per medical routine

Other

No intervention other than routine medical practice

Primary outcomes

  1. 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)

    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:

    • Reduction of RBC, FFP and TC in Units
    • PBM trained physichian in number

Secondary outcomes

  1. Material assets for the PBM pillars

    Time frame: second self audit versus first self audit ( 6 months)

    • increase in use of POC tests (number of tests)
    • increase in use of factor concentrates (IU)
    • local hemostasis management protocols (YES/NO)
  2. Impact of PBM implementation on postoperative care

    Time frame: second self audit versus first self audit ( 6 months)

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

  3. Impact of PBM implementation on postoperative care

    Time frame: second self audit versus first self audit ( 9 months)

    Hospital length of stay (days)

  4. PBM implementation impact on infection rates

    Time frame: second self audit versus first self audit ( 6 months)

    Postoperative infection rate

  5. PBM implemetnation impact on mortality

    Time frame: second self audit versus first self audit ( 6 months)

    30 days mortality

Study contacts

Contact information is provided by the study sponsor or research team.

Anikó Smudla, MD

CONTACT

[email protected]

+36304362384

János Fazakas, Ass Prof

CONTACT

[email protected]

+36208258560

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Collaborators

  • CSL Behring

Registry information

Official study title

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

Acronym: CEEPBM

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 14, 2025
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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