Safety and Effectiveness of a Patient Blood Management (PBM) Program in Surgical Patients

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
SUMMARY

* This epidemiological trial will determine whether the implementation of a PBM program is safe and effective in terms of clinical outcome compared to a pre-implementation cohort * Primary endpoint is a composite outcome comprising in-hospital myocardial infarction, stroke, acute renal failure, death of any cause, pneumonia and sepsis until discharge from hospital in patients before and after implementation of the PBM program. * Secondary endpoints are the length of stay on the intensive care unit, total hospital stay and the quantitative utilization of allogeneic RBC units, platelet concentrates, other blood products (e.g. fresh frozen (therapeutic) plasma), coagulations factors, and cell saver systems during hospital stay. * The primary aim is to prove non-inferiority of the intervention (PBM) group when compared with the control group stratified by center.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• all surgeries with a general or local anaesthetic

• minimum hospital stay of 24 h

• ≥ 18 years

Locations
Other Locations
Germany
Goethe University Hospital
RECRUITING
Frankfurt Am Main
University Hospital Würzburg
RECRUITING
Würzburg
Contact Information
Primary
Kai D Zacharowski, Prof, MD, PhD
Direktion.Anaesthesie@kgu.de
0049 69 6301
Backup
Patrick Meybohm, M.D
patientbloodmanagement@kgu.de
0049 6906301
Time Frame
Start Date: 2012-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 1000000
Treatments
Control cohort
Standard care before implementation (pre-implementation)
PBM cohort
After implementation of PBM program (post-implementation)
Related Therapeutic Areas
Sponsors
Leads: Johann Wolfgang Goethe University Hospital
Collaborators: Fresenius Kabi, Vifor Pharma, CSL Behring, B. Braun Melsungen AG

This content was sourced from clinicaltrials.gov