NCT06363214

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 12, 2024

Completed
19 days until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

April 16, 2024

Status Verified

April 1, 2024

Enrollment Period

9 months

First QC Date

April 9, 2024

Last Update Submit

April 12, 2024

Conditions

Patient Blood Management

Keywords

blood transfusionorthopedic surgerycoagulation

Outcome Measures

Primary Outcomes (2)

  • Perioperative transfusion rates

    Administration of red blood cells, fresh frozen plasma and platelet concentrates (units)

    2019-2024

  • 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 Outcomes (2)

  • Perioperative rates of coagulation products administered

    2019-2024

  • Clinical outcomes

    2019-2024

Interventions

Patient blood managementPROCEDURE

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

Eligibility Criteria

Age16 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Patients who did not sign general informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Christoph K Hofer, MD

    Schulthess Klinik

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christoph K Hofer, MD

CONTACT

00413857462christoph.hofer@kws.ch

Julia Item, PhD

CONTACT

00413857976julia.item@kws.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Anesthesia, Professor, Principal Investigator

Study Record Dates

First Submitted

April 9, 2024

First Posted

April 12, 2024

Study Start

May 1, 2024

Primary Completion

February 1, 2025

Study Completion

April 1, 2025

Last Updated

April 16, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share