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

NCT ID: NCT06363214

Last Updated: 2024-04-16

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

NOT_YET_RECRUITING

Total Enrollment

16000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-31

Study Completion Date

2025-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Patient Blood Management

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Patient blood management

Perioperative optimization of hemoglobin level, perioperative minimization of blood loss, increase of anemia tolerance

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Schulthess Klinik

OTHER

Sponsor Role lead

Responsible Party

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Christoph Hofer

Head of Anesthesia, Professor, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christoph K Hofer, MD

Role: PRINCIPAL_INVESTIGATOR

Schulthess Klinik

Central Contacts

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Christoph K Hofer, MD

Role: CONTACT

00413857462

Julia Item, PhD

Role: CONTACT

00413857976

Other Identifiers

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ANEST-0002

Identifier Type: -

Identifier Source: org_study_id

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