Transfusion Rates in Total Hip Replacement Before/After the Implementation of a Patient Blood Management Program. (pbm-hip)

"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.

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

Study Overview

• Status: Completed
• Conditions: Iron-deficiency; Arthroplasty; Transfusion; Anemia (Diagnosis)
• Intervention / Treatment: Combination product: evaluation by transfusion medicine specialist

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 Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• Italy
  • BO
    • Bologna, BO, Italy, 40128
      • Sandra Giannone

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients of age > 18 who undergo screening and surgery for hip athroplasty in the selected time-frame

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pre-PBM; patients screened for surgery before the implementation of PBM program: pre-operative evaluation and treatment according to usual care
post-PBM; 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; screening for anemia causes and treatment: iron/folate/vitamin B12 supplementation, Erythropoietin administration if indicated

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

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli
• Investigators: Study Chair: Sandra Giannone, MD, Istituto Ortopedico Rizzoli; Principal Investigator: Stefano Bonarelli, MD, Istituto Ortopedico Rizzoli

Publications and helpful links

General Publications

• Ellermann I, Bueckmann A, Eveslage M, Buddendick H, Latal T, Niehoff D, Geissler RG, Hempel G, Kerkhoff A, Berdel WE, Roeder N, Van Aken HK, Zarbock A, Steinbicker AU. Treating Anemia in the Preanesthesia Assessment Clinic: Results of a Retrospective Evaluation. Anesth Analg. 2018 Nov;127(5):1202-1210. doi: 10.1213/ANE.0000000000003583.
• Munoz M, Acheson AG, Auerbach M, Besser M, Habler O, Kehlet H, Liumbruno GM, Lasocki S, Meybohm P, Rao Baikady R, Richards T, Shander A, So-Osman C, Spahn DR, Klein AA. International consensus statement on the peri-operative management of anaemia and iron deficiency. Anaesthesia. 2017 Feb;72(2):233-247. doi: 10.1111/anae.13773. Epub 2016 Dec 20.
• Rineau E, Chaudet A, Chassier C, Bizot P, Lasocki S. Implementing a blood management protocol during the entire perioperative period allows a reduction in transfusion rate in major orthopedic surgery: a before-after study. Transfusion. 2016 Mar;56(3):673-81. doi: 10.1111/trf.13468. Epub 2016 Jan 8.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): November 25, 2022
• Study Completion (Actual): April 4, 2023

Study Registration Dates

• First Submitted: May 12, 2020
• First Submitted That Met QC Criteria: May 20, 2020
• First Posted (Actual): May 21, 2020

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 26, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Arthroplasty; anemia; patient blood management
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Iron Metabolism Disorders; Anemia; Iron Deficiencies
• Other Study ID Numbers: 346/2020/Oss/IOR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No