MedTrace Logo

The German Patient Blood Management Network

NCT02147795 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000000

Last updated 2023-03-10

No results posted yet for this study

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.

Conditions

  • Clinical Safety of a PBM Program

Sponsors & Collaborators

  • Vifor Pharma

    collaborator INDUSTRY

  • B. Braun Melsungen AG

    collaborator INDUSTRY

  • CSL Behring

    collaborator INDUSTRY

  • Fresenius Kabi

    collaborator INDUSTRY

  • Johann Wolfgang Goethe University Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02147795 on ClinicalTrials.gov