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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Johann Wolfgang Goethe University Hospitals
Sponsor:
Collaborators:
University of Schleswig-Holstein
University Hospital, Bonn
University Hospital Muenster
Vifor Pharma
B. Braun Melsungen AG
CSL Behring
Fresenius Kabi
Information provided by (Responsible Party):
Professor Kai Zacharowski, M.D., Ph.D., FRCA, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01820949
First received: March 19, 2013
Last updated: March 26, 2013
Last verified: March 2013

March 19, 2013
March 26, 2013
January 2013
April 2015   (final data collection date for primary outcome measure)
Myocardial infarction, stroke, acute renal failure, death of any cause, pneumonia and sepsisComposite outcome [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: Yes ]
Composite endpoint defined as in-hospital myocardial infarction, stroke, acute renal failure, death of any cause, pneumonia and sepsis until discharge from hospital
Same as current
Complete list of historical versions of study NCT01820949 on ClinicalTrials.gov Archive Site
  • Length of stay on the intensive care unit [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: No ]
  • Total hospital stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: No ]
  • Total number of red blood cell transfusions during hospital stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: No ]
  • Consumption of coagulation factors, crystalloid and colloid infusions [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Effectiveness of a Patient Blood Management (PBM) Program in Surgical Patients
Safety and Effectiveness of a Patient Blood Management (PBM) Program in Surgical Patients

This study will evaluate clinical outcome after the step-wise implementation of a Patient Blood Management (PBM) Program in surgical patients at 4 hospitals.

A PBM program will be implemented stepwise in four University Hospitals, with the intention to optimize preoperative hemoglobin concentration of patients and to standardize transfusion practice within hemotherapy. The PBM program includes 1) an algorithm with the aim to correct preoperative anemia in elective surgery, 2) a strict indication for the transfusion of red blood cells defined by the "Cross-sectional Guidelines for Therapy with Blood Components and Plasma Derivatives" for all surgical patients, and 3) a perioperative checklist for different blood-sparing techniques (e.g. cell-saver, normothermia, reduced blood samples, point-of-care diagnostics for bedside coagulation management).

Primary endpoint: Safety of the use of PBM program will be determined by comparability of the composite outcome (in-hospital myocardial infarction, stroke, acute renal failure, death of any cause, pneumonia and sepsis until discharge from hospital) between patients treated after implementation and patients treated before implementation (control cohort) of the PBM program.

The primary composite endpoint defined as described above will be registered electronically by analysis of Diagnosis Related Groups (DRG) codes. The frequency of these events will be compared between PBM and control cohort stratified by center with a one-sided Mantel-Haenszel test in a non-inferiority setting with significance level of α=2.5% and a non-inferiority margin of 1% for the incidence of the composite endpoint.

Observational
Observational Model: Ecologic or Community
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

all surgical patients over a period of 24 months at 4 hospitals

Surgery
Not Provided
  • Control cohort
    Standard care before implementation (pre-implementation)
  • PBM cohort
    After implementation of PBM program (post-implementation)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80000
June 2015
April 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All non- ambulant, surgical, anesthetized patients (≥18 years)
  • General Surgery, Cardiac Surgery, Thoracic Surgery, Trauma Surgery, Vascular Surgery, Urology, Gynecology, Otolaryngology, Neurosurgery, Crania-Maxillofacial Surgery

Exclusion Criteria:

  • ambulant and all non-surgical anesthetic procedures
  • Surgery in the field of Dermatology or Ophthalmology
Both
18 Years and older
No
Contact: Patrick Meybohm, MD patrick.meybohm@kgu.de
Germany
 
NCT01820949
380/12
Yes
Professor Kai Zacharowski, M.D., Ph.D., FRCA, Johann Wolfgang Goethe University Hospitals
Johann Wolfgang Goethe University Hospitals
  • University of Schleswig-Holstein
  • University Hospital, Bonn
  • University Hospital Muenster
  • Vifor Pharma
  • B. Braun Melsungen AG
  • CSL Behring
  • Fresenius Kabi
Study Chair: Kai Zacharowski, MD, PhD, FRCA University Hospital, Frankfurt
Principal Investigator: Patrick Meybohm, MD University Hospital, Frankfurt
Principal Investigator: Erhard Seifried, MD German Red Cross Blood Service Baden-Württemberg-Hessen, Institute for Transfusion Medicine and Immunohematology of the Goethe University Hospital, Frankfurt
Principal Investigator: Eva Herrmann Institute of Biostatistics and Mathematical Modeling, Goethe University Frankfurt
Johann Wolfgang Goethe University Hospitals
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP