Clinical trial NCT06878105: Patient Blood Management Implementation in CEE Study
Official title: Evaluation of Fixed and Personal Assets for Patient Blood Management Implementation in CEE Countries in Practice
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anemia
Coagulopathy
Lead sponsor: Semmelweis University
Sponsor class: OTHER
Collaborators: name: CSL Behring
First posted: 2025-03-14
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Was the PBM training able to significantly reduce the use of blood products in the audited periods?
timeFrame: second self audit versus first self audit ( 6 months)
Secondary outcomes:
measure: Material assets for the PBM pillars
timeFrame: second self audit versus first self audit ( 6 months)
measure: Impact of PBM implementation on postoperative care
timeFrame: second self audit versus first self audit ( 6 months)
measure: Impact of PBM implementation on postoperative care
timeFrame: second self audit versus first self audit ( 9 months)
measure: PBM implementation impact on infection rates
timeFrame: second self audit versus first self audit ( 6 months)
measure: PBM implemetnation impact on mortality
timeFrame: second self audit versus first self audit ( 6 months)
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University
Study officials:
References:
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