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

Iron-deficiency Clinical Trial

— pbm-hip  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04398238
• Other study ID #: 346/2020/Oss/IOR
• Status: Completed
• Start date: August 1, 2021
• Est. completion date: April 4, 2023

Study information

• Verified date: May 2023
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: April 4, 2023
• Est. primary completion date: November 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia (Diagnosis)
• Arthroplasty
• Iron-deficiency
• Transfusion

Intervention

Combination Product:
• evaluation by transfusion medicine specialist
screening for anemia causes and treatment: iron/folate/vitamin B12 supplementation, Erythropoietin administration if indicated

Locations

Country	Name	City	State
Italy	Sandra Giannone	Bologna	BO

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	minimum hemoglobin	minimum hemoglobin reached after surgery	from day of surgery till day of discharge, up to 60 days
Secondary	hemoglobin at discharge	last measured hemoglobin before discharge from hospital	from day of surgery till day of discharge, up to 60 days
Secondary	length of stay	total days of hospital stay from admission to discharge	from day of surgery till day of discharge, up to 60 days