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

Study Overview
=================
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.

Official Title
-----------------
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.

Conditions
-----------------
Anemia (Diagnosis), Iron-deficiency, Transfusion, Arthroplasty

Intervention / Treatment
-----------------
* Combination Product: evaluation by transfusion medicine specialist


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre-PBM<br>patients screened for surgery before the implementation of PBM program: pre-operative evaluation and treatment according to usual care | |
| post-PBM<br>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. | Combination Product: evaluation by transfusion medicine specialist<br>* screening for anemia causes and treatment: iron/folate/vitamin B12 supplementation, Erythropoietin administration if indicated<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| transfusion rates | percentage of patients undergoing hip replacement who receive at least one unit of concentrated red cells during or after surgery | from day of surgery till day of discharge, up to 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| minimum hemoglobin | minimum hemoglobin reached after surgery | from day of surgery till day of discharge, up to 60 days | 
| hemoglobin at discharge | last measured hemoglobin before discharge from hospital | from day of surgery till day of discharge, up to 60 days | 
| length of stay | total days of hospital stay from admission to discharge | from day of surgery till day of discharge, up to 60 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patient blood management, anemia, Arthroplasty