Patient Blood Management Implementation in CEE Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSemmelweis University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
no patient consent
patients under 18 years of age
pregnant patients
surgery with a low risk of bleeding
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Data collection on interventions performs as per medical routine
Other interventionNo intervention other than routine medical practice
Treatment groups
2,000 Participants
are divided into 2 treatment groupsGroup A: Hospital self audit data baseline before PBM training1 intervention
Group B: Hospital self audit data after 6 month after PBM training1 intervention
Trial outcomes
Primary outcomes
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
Time frame
second self audit versus first self audit ( 6 months)Secondary outcomes
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)
Time frame
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)
Time frame
second self audit versus first self audit ( 6 months)3
Impact of PBM implementation on postoperative care
Hospital length of stay (days)
Time frame
second self audit versus first self audit ( 9 months)4
PBM implementation impact on infection rates
Postoperative infection rate
Time frame
second self audit versus first self audit ( 6 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Semmelweis University
Lead sponsor
CSL Behring
Collaborator
Source ClinicalTrials.gov