Clinical trial NCT01820949: Safety and Effectiveness of a Patient Blood Management (PBM) Program in Surgical Patients
Official title: Safety and Effectiveness of a Patient Blood Management (PBM) Program in Surgical Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Keywords: patient blood management
patients safety
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital Schleswig-Holstein
name: University Hospital, Bonn
name: University Hospital Muenster
name: Vifor Pharma
name: B. Braun Melsungen AG
name: CSL Behring
name: Fresenius Kabi
First posted: 2013-03-29
Enrollment: 110000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all surgical patients over a period of 24 months at 4 hospitals

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.

Eligibility 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

Primary outcomes:
measure: Myocardial infarction, stroke, acute renal failure, death of any cause, pneumonia and sepsisComposite outcome
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary outcomes:
measure: Length of stay on the intensive care unit
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Total hospital stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Total number of red blood cell transfusions during hospital stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Consumption of coagulation factors
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University Hospital Bonn
city: Frankfurt
country: Germany
facility: University Hospital Frankfurt
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein
city: Muenster
country: Germany
facility: University Hospital Muenster
Study officials:
affiliation: Goethe University
name: Kai Zacharowski, MD, PhD, FRCA
role: STUDY_CHAIR
affiliation: Goethe University
name: Patrick Meybohm, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: German Red Cross Blood Service Baden-Württemberg-Hessen, Institute for Transfusion Medicine and Immunohematology of the Goethe University Hospital, Frankfurt
name: Erhard Seifried, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Biostatistics and Mathematical Modeling, Goethe University Frankfurt
name: Eva Herrmann
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ellermann I, Bueckmann A, Eveslage M, Buddendick H, Latal T, Niehoff D, Geissler RG, Hempel G, Kerkhoff A, Berdel WE, Roeder N, Van Aken HK, Zarbock A, Steinbicker AU. Treating Anemia in the Preanesthesia Assessment Clinic: Results of a Retrospective Evaluation. Anesth Analg. 2018 Nov;127(5):1202-1210. doi: 10.1213/ANE.0000000000003583.
citation: Meybohm P, Herrmann E, Steinbicker AU, Wittmann M, Gruenewald M, Fischer D, Baumgarten G, Renner J, Van Aken HK, Weber CF, Mueller MM, Geisen C, Rey J, Bon D, Hintereder G, Choorapoikayil S, Oldenburg J, Brockmann C, Geissler RG, Seifried E, Zacharowski K; PBM-study Collaborators. Patient Blood Management is Associated With a Substantial Reduction of Red Blood Cell Utilization and Safe for Patient's Outcome: A Prospective, Multicenter Cohort Study With a Noninferiority Design. Ann Surg. 2016 Aug;264(2):203-11. doi: 10.1097/SLA.0000000000001747.
citation: Meybohm P, Fischer DP, Geisen C, Muller MM, Weber CF, Herrmann E, Steffen B, Seifried E, Zacharowski K; German PBM Study Core Group. Safety and effectiveness of a Patient Blood Management (PBM) program in surgical patients--the study design for a multi-centre prospective epidemiologic non-inferiority trial. BMC Health Serv Res. 2014 Nov 19;14:576. doi: 10.1186/s12913-014-0576-3.