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

NCT ID: NCT04398238

Last Updated: 2023-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-01

Study Completion Date

2023-04-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anemia (Diagnosis) Iron-deficiency Transfusion Arthroplasty

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pre-PBM

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

No interventions assigned to this group

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.

evaluation by transfusion medicine specialist

Intervention Type COMBINATION_PRODUCT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

evaluation by transfusion medicine specialist

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

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stefano Bonarelli, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Ortopedico Rizzoli

Sandra Giannone, MD

Role: STUDY_CHAIR

Istituto Ortopedico Rizzoli

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sandra Giannone

Bologna, BO, Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 29944518 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27996086 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26748489 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

346/2020/Oss/IOR

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.