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

September 4, 2015 updated by: Professor Kai Zacharowski, M.D., Ph.D., FRCA, Johann Wolfgang Goethe University Hospital
This study will evaluate clinical outcome after the step-wise implementation of a Patient Blood Management (PBM) Program in surgical patients at 4 hospitals.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

110000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bonn, Germany
        • University Hospital Bonn
      • Frankfurt, Germany
        • University Hospital Frankfurt
      • Kiel, Germany
        • University Hospital Schleswig-Holstein
      • Muenster, Germany
        • University Hospital Muenster

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Composite endpoint defined as in-hospital myocardial infarction, stroke, acute renal failure, death of any cause, pneumonia and sepsis until discharge from hospital
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Total hospital stay
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Consumption of coagulation factors
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johann Wolfgang Goethe University Hospital

Collaborators

University Hospital Muenster
CSL Behring
University Hospital, Bonn
B. Braun Melsungen AG
University Hospital Schleswig-Holstein
Vifor Pharma
Fresenius Kabi

Investigators

  • Study Chair: Kai Zacharowski, MD, PhD, FRCA, 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

March 19, 2013

First Submitted That Met QC Criteria

March 26, 2013

First Posted (Estimate)

March 29, 2013

Study Record Updates

Last Update Posted (Estimate)

September 7, 2015

Last Update Submitted That Met QC Criteria

September 4, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 380/12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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