Transfusion Rates in Total Hip Replacement Before/After the Implementation of a Patient Blood Management Program.

"Change in Transfusion Rates of Patients Undergoing Elective Total Hip Replacement Before/After the Implementation of a Peri-operative Patient Blood Management Program: a Retrospective Observational Study.

Sponsors

Lead Sponsor: Istituto Ortopedico Rizzoli

Source Istituto Ortopedico Rizzoli
Brief Summary

Retrospective observational study: impact of a peri-operative patient blood management program (PBM) on transfusion rates of patients undergoing elective hip replacement.

Detailed Description

A Patient Blood Management (PBM) program was implemented in year 2019 in our institution: patient scheduled for elective total hip replacement underwent pre-operative screening about one month before surgery, and those with pre-operative hemoglobin < 13 g/dl were screened for possible causes and treatment of anemia. Data from two different time frames, before and after the implementation of the program, were collected to study the change in clinical outcomes such as transfusion rates, length of stay, etc.

Overall Status Not yet recruiting
Start Date November 1, 2020
Completion Date August 15, 2021
Primary Completion Date May 25, 2021
Study Type Observational
Primary Outcome
Measure Time Frame
transfusion rates from day of surgery till day of discharge, up to 60 days
Secondary Outcome
Measure Time Frame
minimum hemoglobin from day of surgery till day of discharge, up to 60 days
hemoglobin at discharge from day of surgery till day of discharge, up to 60 days
length of stay from day of surgery till day of discharge, up to 60 days
Enrollment 480
Condition
Intervention

Intervention Type: Combination Product

Intervention Name: evaluation by transfusion medicine specialist

Description: screening for anemia causes and treatment: iron/folate/vitamin B12 supplementation, Erythropoietin administration if indicated

Arm Group Label: post-PBM

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

Inclusion Criteria: - undergoing elective hip replacement in the selected time-frame - American Society of Anesthesiology (ASA) status 1-2-3 - age >18 Exclusion Criteria: - patients not undergoing screening as outpatients at pre-operative clinic

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: Sandra Giannone, MD

Phone: +393203382071

Email: [email protected]

Location
Facility: Sandra Giannone
Location Countries

Italy

Verification Date

May 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Pre-PBM

Description: patients screened for surgery before the implementation of PBM program: pre-operative evaluation and treatment according to usual care

Label: post-PBM

Description: patients screened for surgery after the implementation of PBM program (3 months allowed for training/optimization): all patients with pre-operative hemoglobin < 13g/dl undergo screening for causes and treatment as needed.

Acronym pbm-hip
Patient Data Undecided
Study Design Info

Observational Model: Cohort

Time Perspective: Retrospective

Source: ClinicalTrials.gov