Patient Blood Management Program in Total Hip or Total Knee Arthroplasty

NCT04137484 | Completed

• 1 other identifier: RECHMPL19_0484
• Study Type: observational
• Target: 723
• Locations: 1 country
• Sites: 1

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. "

Conditions

Knee Arthropathy; Hip Arthropathy

Keywords

Patient Blood Management Program; Transfusion; Postoperative anemia

Outcome Measures

Primary Outcomes (2)

• Blood transfusion induced by postoperative anemia at hospital discharge

  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.

  before the anesthesia consultation, the day before surgery, and after surgery at day 1, day 3 and day 5 if still admitted

• Blood transfusion induced by postoperative anemia at hospital discharge

  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.

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

Secondary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Study Officials

• Philippe BIBOULET, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 24, 2019
• Study Start: July 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2016
• Last Updated: March 10, 2020

Record last verified: 2020-03

Locations

FR (1)