Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06363214
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-09
Brief Title:
Impact of Patient Blood Management PBM at the Schulthess Clinic
Sponsor:
Schulthess Klinik
Organization:
Schulthess Klinik
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PBM
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 RBCs 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 763 735 and 992 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None