Patient Blood Management Implementation in CEE Study (CEEPBM)

March 10, 2025 updated by: Dr. Fazakas János, Semmelweis University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hospital self audit data baseline before PBM training
Anticipated 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.
Other: Data collection on interventions performs as per medical routine
No intervention other than routine medical practice
Hospital self audit data after 6 month after PBM training
Anticipated 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.
Other: Data collection on interventions performs as per medical routine
No intervention other than routine medical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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:

  1. Reduction of RBC, FFP and TC in Units
  2. PBM trained physichian in number
second self audit versus first self audit ( 6 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Material assets for the PBM pillars
Time Frame: second self audit versus first self audit ( 6 months)
  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)
second self audit versus first self audit ( 6 months)
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)
second self audit versus first self audit ( 6 months)
Impact of PBM implementation on postoperative care
Time Frame: second self audit versus first self audit ( 9 months)
Hospital length of stay (days)
second self audit versus first self audit ( 9 months)
PBM implementation impact on infection rates
Time Frame: second self audit versus first self audit ( 6 months)
Postoperative infection rate
second self audit versus first self audit ( 6 months)
PBM implemetnation impact on mortality
Time Frame: second self audit versus first self audit ( 6 months)
30 days mortality
second self audit versus first self audit ( 6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University

Collaborators

CSL Behring

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2024

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

August 2, 2024

First Submitted That Met QC Criteria

March 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CG90142103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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