The German Patient Blood Management Network

Clinical Safety of a PBM Program Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02147795
• Other study ID #: PBM01
• Status: Recruiting
• Start date: January 2012
• Est. completion date: December 2025

Study information

• Verified date: March 2023
• Source: Johann Wolfgang Goethe University Hospital
• Contact: Kai D Zacharowski, Prof, MD, PhD
• Phone: 0049 69 6301
• Email: Direktion.Anaesthesie[@]kgu.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Background: The transfusion of allogeneic red blood cell units might be associated with increased morbidity and mortality due to infectious, immunological, pulmonary and thromboembolic complications. However, transfusion practice currently varies significantly between hospitals and even between physicians and Patient Blood Management programs have not been implemented nationwide in Germany yet. Patient Blood Management (PBM) concepts aim to identify and optimize patients at risk of allogeneic blood transfusions, to promote blood-sparing techniques and restrictive transfusion practices. A rational use of red blood cell concentrates and safe clinical transfusion practice is mandatory. The purpose of the German PBM network is to evaluate the safety of a standardized, evidence-based Patient Blood management concept.

Study Design and Methods: This epidemiological study is a follow-up of a study that is already being carried out in four German university hospitals. This new prospective, multi-centre trial comprises approximately 20 different hospitals of varying size and levels of patient care. A patient-centred, evidence-based Patient Blood Management program will be enrolled in each of these hospitals reforming the care of adult patients undergoing any type of surgery. This PBM program includes the following three main pillars: 1) preoperative optimization of hemoglobin levels in high-risk patients with anaemia, 2) standardization of transfusion practice and transfusion triggers according to evidence-based guidelines and 3) alternatives to transfusion of allogeneic RBC concentrates and blood-sparing techniques (like routine use of cell saver systems, point-of-care diagnostics, optimized coagulation management, restrictive blood sampling).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000000
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Clinical Safety of a PBM Program

Locations

Country	Name	City	State
Germany	Goethe University Hospital	Frankfurt am Main	Hessen
Germany	University Hospital Würzburg	Würzburg

Sponsors (5)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospital	B. Braun Melsungen AG, CSL Behring, Fresenius Kabi, Vifor Pharma

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Outcome for and after PBM program	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	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary	Length of stay	length of stay on the intensive care unit, total hospital stay	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary	haemotherapy	the quantitative utilization of allogeneic RBC units, platelet concentrates, other blood products (e.g. fresh frozen (therapeutic) plasma), coagulations factors, and any other haemotherapy (including use of cell salvage	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks