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

Completed

• Conditions: Transfusion; Anemia (Diagnosis); Iron-deficiency; Arthroplasty
• Interventions: Combination Product: evaluation by transfusion medicine specialist

• Registration Number: NCT04398238
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2020-05-12
• Study First Submitted QC: 2020-05-20
• Study First Posted: 2020-05-21
• Study Start: 2021-08-01
• Primary Completion: 2022-11-25
• Study Completion: 2023-04-04
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-26
• Last Update Posted: 2023-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
post-PBM	evaluation by transfusion medicine specialist	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.

Primary Outcome Measures

Name	Time	Method
transfusion rates	from day of surgery till day of discharge, up to 60 days	percentage of patients undergoing hip replacement who receive at least one unit of concentrated red cells during or after surgery

Secondary Outcome Measures

Name	Time	Method
hemoglobin at discharge	from day of surgery till day of discharge, up to 60 days	last measured hemoglobin before discharge from hospital
minimum hemoglobin	from day of surgery till day of discharge, up to 60 days	minimum hemoglobin reached after surgery
length of stay	from day of surgery till day of discharge, up to 60 days	total days of hospital stay from admission to discharge

Trial Locations

Locations (1)

Sandra Giannone; 🇮🇹 Bologna, BO, Italy