An observational study in Anemia and Coagulopathy, sponsored by Semmelweis University. Recruiting at 1 site in Hungary. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-14.
Sponsored by Semmelweis University · Observational
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.
The goals of the PBM program:
bleeding management based on latest scientific guidelines including:
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):
Patient level data:
1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 270 across 368 observational studies indexed under Anemia.
Browse Anemia studies →Semmelweis University is the lead sponsor of 140 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
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)
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)
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)
Impact of PBM implementation on postoperative care
Hospital length of stay (days)
Time frame: second self audit versus first self audit ( 9 months)
PBM implementation impact on infection rates
Postoperative infection rate
Time frame: second self audit versus first self audit ( 6 months)
PBM implemetnation impact on mortality
30 days mortality
Time frame: second self audit versus first self audit ( 6 months)
Plan to share: Undecided
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