Patient Blood Management Program in Total Hip or Total Knee Arthroplasty

NCT ID: NCT04137484

Last Updated: 2020-03-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 723 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-07-01
• Study Completion Date: 2016-08-01

Brief Summary

Total hip and knee arthroplasty are among the most common surgical procedures for which blood transfusion is prescribed. Patient blood management program has been proposed to decrease the need for transfusion. This program involve three pillars: preoperative improvement of erythropoiesis, intraoperative reduction of bleeding and postoperative management of anemia.

Among the different steps of this program, reduction of bleeding and optimization of anemia are gaining popularity, but preoperative improvement of erythropoiesis is underused. The preoperative step of the blood management program is not systematically used because it requires a complex organization, is considered expensive, and finally because the others available techniques to reduce blood transfusion are easier to implement.

The aim of this study was to assess, within a patient blood management program, the effectiveness of erythropoietin on reducing allogenic blood transfusion and anemia in patients requiring elective total hip or knee arthroplasty. "

Detailed Description

This is a post-hoc analysis using part of the patients involved in the Cross Iron Study (Anesthesiology. 2018 Oct;129(4):710-720 ) Included patients were all the patients scheduled for elective primary total hip or knee arthroplasty and assessed by an anesthesiologist involved in the Cross Iron Study. Exclusion criteria were pregnancy, age under 18 years old, systemic infection, bilateral arthroplasty, revision arthroplasty, and participation in a preoperative autologous donation program.

This was a observational study. The patient blood management program included: erythropoietin with iron supplementation if preoperative hemoglobin was lower than 13 g/dl; tranexamic acid during surgery; intravenous iron postoperatively and use of prespecified thresholds for homologous blood transfusion. Blood transfusion and anemia were assessed until day 5 or discharge, whichever came first. Major thromboembolic or cardiovascular events were assessed during admission and one month after discharge.

Conditions

Knee Arthropathy; Hip Arthropathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• patient from the flow chart of the Cross Iron Study (Anesthesiology. 2018 Oct;129(4):710-720 )
• patient scheduled for elective primary total hip or knee arthroplasty

Exclusion Criteria

• pregnancy patient,
• patient under 18 years old
• systemic infection
• bilateral arthroplasty
• revision arthroplasty,
• participation in a preoperative autologous donation program.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe BIBOULET, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

Uhmontpellier

Montpellier, , France

Countries

France

Other Identifiers

RECHMPL19_0484

Identifier Type: -

Identifier Source: org_study_id