Evaluating the safety and effectiveness of a Patient Blood Management program in hospitals
Safety and Effectiveness of a Patient Blood Management (PBM) Program in Surgical Patients
This study is testing if a new Patient Blood Management program in hospitals can keep patients safer and healthier compared to the usual care they receive.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johann Wolfgang Goethe University Hospital Academic / other |
| Locations | 2 sites (Frankfurt am Main, Hessen and 1 other locations) |
| Trial ID | NCT02147795 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the clinical safety and effectiveness of a Patient Blood Management (PBM) program implemented across approximately 20 hospitals in Germany. It will compare patient outcomes before and after the implementation of the PBM program, focusing on various clinical endpoints such as myocardial infarction, stroke, and mortality. The study will also evaluate secondary outcomes including length of hospital stay and utilization of blood products. The goal is to establish the non-inferiority of the PBM program compared to traditional practices.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older undergoing any type of surgery requiring a minimum hospital stay of 24 hours.
Not a fit: Patients undergoing outpatient, ophthalmologic, or dermatologic surgeries, or those under 18 years old, may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could enhance patient safety and optimize blood transfusion practices, potentially reducing complications associated with transfusions.
How similar studies have performed: Previous studies have shown promising results with similar Patient Blood Management approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * all surgeries with a general or local anaesthetic * minimum hospital stay of 24 h * ≥ 18 years Exclusion Criteria: * \< 18 years * ophthalmologic or dermatologic or outpatient surgery * all non-surgical anesthetic procedures
Where this trial is running
Frankfurt am Main, Hessen and 1 other locations
- Goethe University Hospital — Frankfurt am Main, Hessen, Germany (Recruiting)
- University Hospital Würzburg — Würzburg, Germany (Recruiting)
Study contacts
- Study coordinator: Kai D Zacharowski, Prof, MD, PhD
- Email: Direktion.Anaesthesie@kgu.de
- Phone: 0049 69 6301
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.