Clinical trial NCT04137484: Patient Blood Management Program in Total Hip or Total Knee Arthroplasty
Official title: Evaluation of a Patient Blood Management Program in Total Hip or Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Arthropathy
Hip Arthropathy
Keywords: Patient Blood Management Program
Transfusion
Postoperative anemia
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-10-24
Enrollment: 723
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the flow chart of 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.

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.

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.

Primary outcomes:
measure: Blood transfusion induced by postoperative anemia at hospital discharge
timeFrame: before the anesthesia consultation, the day before surgery, and after surgery at day 1, day 3 and day 5 if still admitted
measure: Blood transfusion induced by postoperative anemia at hospital discharge
timeFrame: before the anesthesia consultation, the day before surgery, and after surgery at day 1, day3 and day 5 if still admitted
Secondary outcomes:
measure: Rate of major complications one month after surgery
timeFrame: 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
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Philippe BIBOULET, MD
role: PRINCIPAL_INVESTIGATOR
References: