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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

110000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-09-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Surgery

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

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Control cohort

Standard care before implementation (pre-implementation)

No interventions assigned to this group

PBM cohort

After implementation of PBM program (post-implementation)

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Professor Kai Zacharowski, M.D., Ph.D., FRCA

Prof. Dr. Dr. Kai Zacharowski

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kai Zacharowski, MD, PhD, FRCA

Role: STUDY_CHAIR

Goethe University

Patrick Meybohm, MD

Role: PRINCIPAL_INVESTIGATOR

Goethe University

Erhard Seifried, MD

Role: PRINCIPAL_INVESTIGATOR

German Red Cross Blood Service Baden-Württemberg-Hessen, Institute for Transfusion Medicine and Immunohematology of the Goethe University Hospital, Frankfurt