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

Completed

• Conditions: Surgery

• Registration Number: NCT01820949
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

Brief Summary

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

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 Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-03-19
• Study First Submitted QC: 2013-03-26
• Study First Posted: 2013-03-29
• Primary Completion: 2015-07
• Status Verified: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-04
• Last Update Posted: 2015-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Myocardial infarction, stroke, acute renal failure, death of any cause, pneumonia and sepsisComposite outcome	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

Secondary Outcome Measures

Name	Time	Method
Total hospital stay	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Length of stay on the intensive care unit	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	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Consumption of coagulation factors	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Trial Locations

Locations (4)

University Hospital Frankfurt; 🇩🇪 Frankfurt, Germany

University Hospital Muenster; 🇩🇪 Muenster, Germany

University Hospital Schleswig-Holstein; 🇩🇪 Kiel, Germany

University Hospital Bonn; 🇩🇪 Bonn, Germany