We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The German Patient Blood Management Network

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02147795
Recruitment Status : Recruiting
First Posted : May 28, 2014
Last Update Posted : August 30, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease
Clinical Safety of a PBM Program

Detailed 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).


Study Design

Study Type : Observational
Estimated Enrollment : 200000 participants
Observational Model: Cohort
Official Title: Safety and Effectiveness of a Patient Blood Management (PBM) Program in Surgical Patients
Study Start Date : January 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018
Groups and Cohorts

Group/Cohort
Control cohort
Standard care before implementation (pre-implementation)
PBM cohort
After implementation of PBM program (post-implementation)


Outcome Measures

Primary Outcome Measures :
  1. Composite Outcome for and after PBM program [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]
    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 Outcome Measures :
  1. Length of stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]
    length of stay on the intensive care unit, total hospital stay

  2. haemotherapy [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]
    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


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adult surgical patients
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02147795


Contacts
Contact: Kai D Zacharowski, Prof, MD, PhD 0049 69 6301 ext 5998 Direktion.Anaesthesie@kgu.de
Contact: Patrick Meybohm, M.D 0049 6906301 ext 5998 patientbloodmanagement@kgu.de

Locations
Germany
Johann Wolfgang Goethe University Hospitals Recruiting
Frankfurt, Germany, 60590
Contact: Dania P Fischer, M.D    +49 (0) 157 76400784    dania.fischer@kgu.de   
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Vifor Pharma
B. Braun Melsungen AG
CSL Behring
Fresenius Kabi
More Information

Responsible Party: Professor Kai Zacharowski, M.D., Ph.D., FRCA, Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier: NCT02147795     History of Changes
Other Study ID Numbers: PBM01
First Posted: May 28, 2014    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016

Keywords provided by Professor Kai Zacharowski, M.D., Ph.D., FRCA, Johann Wolfgang Goethe University Hospital:
Patient Blood Management
Red Blood Cell Transfusion Practice
Patient Safety
Anemia
Clinical Outcome
perioperative care