- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04137484
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
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. "
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Montpellier, France, 34295
- Uhmontpellier
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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, day 3 and day 5 if still admitted
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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.
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before the anesthesia consultation, the day before surgery, and after surgery at day 1, day 3 and day 5 if still admitted
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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
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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.
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before the anesthesia consultation, the day before surgery, and after surgery at day 1, day3 and day 5 if still admitted
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of major complications one month after surgery
Time Frame: 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
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Major complications including thromboembolic events, cardiac or respiratory failure, 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
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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
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Philippe BIBOULET, MD, University Hospital, Montpellier
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RECHMPL19_0484
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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