Patient Blood Management Implementation in CEE Study (CEEPBM)

Semmelweis University

Status: Enrolling

Conditions: Anemia; Coagulopathy

Treatments: Other: Data collection on interventions performs as per medical routine

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06878105

CG90142103

Details and patient eligibility

About

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.

Full 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

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,000 participants in 2 patient groups

Hospital self audit data baseline before PBM training

Description:

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.

Treatment:

Other: Data collection on interventions performs as per medical routine

Hospital self audit data after 6 month after PBM training

Description:

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.

Treatment:

Other: Data collection on interventions performs as per medical routine