Impact of Patient Blood Management (PBM) at the Schulthess Clinic (PBM)

Impact of Patient Blood Management (PBM) at the Schulthess Clinic A Quality Assurance and Quality Control Project in Major Orthopaedic and Spine Surgery

Aim of this study is to analyze the transfusion requirements of allogenic blood products at the Schulthess Clinic for patients that had major orthopedic or major spine surgery between 2019 and 2024 order to identify patients at risk for transfusion. Moreover, impact of transfusion requirements and other measures of PBM on patient outcomes will be assessed. These data are required to further improve PBM at the Schulthess Clinic.

Study Overview

• Status: Not yet recruiting
• Conditions: Patient Blood Management
• Intervention / Treatment: Procedure: Patient blood management

Detailed Description

At the Schulthess Clinic a significant reduction of RBC's, fresh frozen plasma (FFP) and platelets transfusion could be observed between 2018 and 2022 during the stepwise introduction of PBM for all patients undergoing major orthopedic and spine surgery. RBC, FFP and PT transfusion declined by 76.3%, 73.5% and 99.2% over the 5-year period. Unfortunately however, at the moment no detailed analysis with respect to risk factors for transfusion, specific interventions or outcomes is available. The hypothesis is that the already known reduction of allogenic blood product transfusion at the Schulthess Clinic can be attributed to patients undergoing major primary joint arthroplasties, revision operations and major spine surgery. We assume that patient and procedure related risk factors over time did not significantly change while we expect a major impact of changed transfusion requirements and the stepwise PBM implementation on patient outcomes.

• Study Type: Observational
• Enrollment (Estimated): 16000

Contacts and Locations

• Study Contact: Name: Christoph K Hofer, MD; Phone Number: 00413857462; Email: christoph.hofer@kws.ch
• Study Contact Backup: Name: Julia Item, PhD; Phone Number: 00413857976; Email: julia.item@kws.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective major orthopedic or spine surgery at the Schulthess Clinic between 2019 and 2024.

Description

Inclusion Criteria:

• Patients undergoing primary joint arthroplasties or revision surgery: CHOP Code: 81.51, 81.52, 81.52, 81.54
• Patients undergoing major spine surgery: CHOP Code: 7A.6, 7A.7

Exclusion Criteria:

• Patients who did not sign general informed consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk factors for perioperative transfusion Risk factors for perioperative transfusion Risk factorsfor perioperative transfusion	Identification of patient groups with increased transfusion rates	2019-2024
Perioperative transfusion rates	Administration of red blood cells, fresh frozen plasma and platelet concentrates (units)	2019-2024

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical outcomes	Infections: Wound, sepsis, drug-resistant, Clostridium difficilis.; Ischemic events: TIA, cerebrovascular, myocardial; Thrombotic: Deep venous thrombosis (DVT), pulmonary embolism (Barrie et al.); Renal failure; Pulmonary failure	2019-2024
Perioperative rates of coagulation products administered	Administration of prothrombin complex, fibrinogen, other coagulation factors	2019-2024

Collaborators and Investigators

• Sponsor: Schulthess Klinik
• Investigators: Principal Investigator: Christoph K Hofer, MD, Schulthess Klinik

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: April 9, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: blood transfusion; orthopedic surgery; coagulation
• Other Study ID Numbers: ANEST-0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No