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Clinical Trials/NCT04137484
NCT04137484
Completed
Not Applicable

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

University Hospital, Montpellier1 site in 1 country723 target enrollmentJuly 1, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Arthropathy
Sponsor
University Hospital, Montpellier
Enrollment
723
Locations
1
Primary Endpoint
Blood transfusion induced by postoperative anemia at hospital discharge
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2014
End Date
August 1, 2016
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Blood transfusion induced by postoperative anemia at hospital discharge

Time Frame: before the anesthesia consultation, the day before surgery, and after surgery at day 1, day3 and day 5 if still admitted

Hemoglobin was systematically assessed during surgery and after surgery at day 1, day 3 and day 5 if still admitted. The Hb thresholds for homologous blood transfusion used during the intra- and postoperative period were 7 g/dl in healthy patients in the absence of physical activity, 8 to 9 g/dl in the presence of physical activity (early rehabilitation) or in patients with cardiovascular disease, and 10 g/dl in patients with cardiac or coronary insufficiency.

Secondary Outcomes

  • Rate of major complications one month after surgery(admission in intensive care unit, and death were reported on day 3, on day 5 if still admitted, and one month after surgery at the routine postoperative surgical consultation)

Study Sites (1)

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