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

Patient Blood Management Clinical Trial

— PBM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06363214
• Other study ID #: ANEST-0002
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: Schulthess Klinik
• Contact: Christoph K Hofer, MD
• Phone: 00413857462
• Email: christoph.hofer[@]kws.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16000
• Est. completion date: April 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Patient Blood Management

Intervention

Procedure:
• Patient blood management
Perioperative optimization of hemoglobin level, perioperative minimization of blood loss, increase of anemia tolerance

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Schulthess Klinik

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative transfusion rates	Administration of red blood cells, fresh frozen plasma and platelet concentrates (units)	2019-2024
Primary	Risk factors for perioperative transfusion Risk factors for perioperative transfusion Risk factorsfor perioperative transfusion	Identification of patient groups with increased transfusion rates	2019-2024
Secondary	Perioperative rates of coagulation products administered	Administration of prothrombin complex, fibrinogen, other coagulation factors	2019-2024
Secondary	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