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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06363214
Acronym
PBM
Enrollment
16000
Registered
2024-04-12
Start date
2024-05-31
Completion date
2025-04-30
Last updated
2024-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Blood Management

Keywords

blood transfusion, orthopedic surgery, coagulation

Brief 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.

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.

Interventions

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

Sponsors

Schulthess Klinik
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Perioperative transfusion rates2019-2024Administration of red blood cells, fresh frozen plasma and platelet concentrates (units)
Risk factors for perioperative transfusion Risk factors for perioperative transfusion Risk factorsfor perioperative transfusion2019-2024Identification of patient groups with increased transfusion rates

Secondary

MeasureTime frameDescription
Perioperative rates of coagulation products administered2019-2024Administration of prothrombin complex, fibrinogen, other coagulation factors
Clinical outcomes2019-2024* 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

Contacts

Primary ContactChristoph K Hofer, MD
christoph.hofer@kws.ch00413857462
Backup ContactJulia Item, PhD
julia.item@kws.ch00413857976

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026