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CompletedNCT04137484

Patient Blood Management Program in Total Hip or Total Knee Arthroplasty

Evaluation of a Patient Blood Management Program in Total Hip or Total Knee Arthroplasty

Status
Completed
Phase
Study type
Observational
Enrollment
723 (actual)
Sponsor
University Hospital, Montpellier · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Timeline

Start date
2014-07-01
Primary completion
2014-08-01
Completion
2016-08-01
First posted
2019-10-24
Last updated
2020-03-10

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04137484. Inclusion in this directory is not an endorsement.

Patient Blood Management Program in Total Hip or Total Knee Arthroplasty (NCT04137484) · Clinical Trials Directory