Trial record 19 of 23 for:    Open Studies | "Patient Safety"

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

This study is currently recruiting participants.
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
  Purpose

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


Condition
Surgery

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Safety and Effectiveness of a Patient Blood Management (PBM) Program in Surgical Patients

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80000
Study Start Date: January 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Control cohort
Standard care before implementation (pre-implementation)
PBM cohort
After implementation of PBM program (post-implementation)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01820949

Contacts
Contact: Patrick Meybohm, MD patrick.meybohm@kgu.de

Locations
Germany
University Hospital Bonn Not yet recruiting
Bonn, Germany
Contact: Maria Wittmann, MD       Maria.Wittmann@ukb.uni-bonn.de   
Contact: Georg Baumgarten         
Principal Investigator: Georg Baumgarten, MD         
Sub-Investigator: Maria Wittmann, MD         
Sub-Investigator: Andreas Hoeft, MD         
University Hospital Frankfurt Recruiting
Frankfurt, Germany
Contact: Patrick Meybohm, MD       patrick.meybohm@kgu.de   
Contact: Kai Zacharowski, MD, PhD, FRCA         
Principal Investigator: Kai Zacharowski, MD, PhD, FRCA         
Sub-Investigator: Patrick Meybohm, MD         
Sub-Investigator: Markus Müller, MD         
Sub-Investigator: Christoph Geisen, MD         
Sub-Investigator: Erhard Seifried, MD         
Sub-Investigator: Dania Fischer, MD         
Sub-Investigator: Stefan Zeuzem, MD         
Sub-Investigator: Judith Nussbaumer, MD         
University Hospital Schleswig-Holstein Not yet recruiting
Kiel, Germany
Contact: Jochen Renner, MD       jochen.renner@kgu.de   
Contact: Berthold Bein, MD       berthold.bein@kgu.de   
Principal Investigator: Jochen Renner, MD         
Sub-Investigator: Berthold Bein, MD, MA, DESA         
Sub-Investigator: Jens Scholz, MD         
University Hospital Muenster Not yet recruiting
Muenster, Germany
Contact: Alexander Zarbock, MD         
Principal Investigator: Alexander Zarbock, MD         
Sponsors and Collaborators
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
Investigators
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
  More Information

No publications provided

Responsible Party: Professor Kai Zacharowski, M.D., Ph.D., FRCA, Prof. Dr. Dr. Kai Zacharowski, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT01820949     History of Changes
Other Study ID Numbers: 380/12
Study First Received: March 19, 2013
Last Updated: March 26, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Johann Wolfgang Goethe University Hospitals:
patient blood management
patients safety

ClinicalTrials.gov processed this record on April 16, 2014