Can Pre-operative Anemia be Timely Identified and Optimized in Patients Awaiting Primary Arthroplasty Surgery? A Randomized Clinical Trial

Anemia Clinical Trial

Official title:

Can Pre-operative Anemia be Timely Identified and Optimized in Patients Awaiting Primary Arthroplasty Surgery? A Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05648942
• Other study ID #: 20200795-01H
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: December 2022
• Source: Ottawa Hospital Research Institute
• Contact: Isabel Horton
• Phone: 613-737-8899
• Email: ihorton[@]ohri.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Reducing the occurrence of anemia (low circulating hemoglobin levels) post-surgery has been associated with improved outcome, as it reduces complications and allows for faster return to pre-operative function. Post-operative hemoglobin level is dependent upon its pre-operative value (for a given amount of blood loss). About 17% of patients at the Ottawa Hospital (TOH), will be anemic pre-operatively, and if left untreated the patients will have significantly inferior outcomes compared to non-anemic patients. In order to improve outcomes, when a patient is identified as anemic, typically at the pre-operative assessment clinic, he/she is invited to be reviewed and optimized at the Pre-operative Blood Optimization Clinic (PBOC). However, only a quarter of anemic patients are seen in the PBOC due to the lack of time available between anemia identification and surgery and the current resources available. This project will focus on hemoglobin level optimization of pre-operative hip and knee, primary, arthroplasty patients to demonstrate whether early assessment and treatment of pre-operative anemia can be successfully integrated into practice and its impact on post-operative outcomes. Patients will be randomly assigned to either the current standard of care pathway with an anemia test at the pre-operative assessment clinic (2-4 weeks before surgery), at which time they have the option to seek treatment. Patients who are randomly selected to be in the experimental group, will undergo a test to detect anemia at the time they consent for surgery, which is usually 4-6 months prior to surgery. Patients with anemia, will be invited for treatment at the blood optimization clinic at this time. In doing so, this project will test whether timely identification and simple measures is feasible and whether such practice can reduce the overall anemia burden and ultimately improve patient outcome.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 800
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age

• Undergoing primary arthroplasty procedure

• Willing and able to provide informed consent

Exclusion Criteria:

• Patients who are not eligible for assessment and optimization in the preoperative blood optimization clinic. This includes patients with end-stage renal disease (ESRD) or other renal conditions under the care of nephrologists, receiving erythropoietin treatment

• Patients with known hematological malignancy or other hematological conditions which are already on some form of anemia treatment

Related Conditions & MeSH terms

• Anemia
• Hip Osteoarthritis
• Osteoarthritis, Hip

Intervention

Diagnostic Test:
• Anemia testing
Patients will undergo a point of care test to identify possible anemia

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Canadian Blood Services

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility - Enrollment	Number of participants enrolled and willingness of participants to be randomized Comparing the Number of patients screened compared to the number of patients meeting eligibility criteria.; Tracking crossover between the treatment groups, participant retention, and follow-up rates.	Two years
Primary	Study Feasibility - Follow-up	Rates of participant follow-up	Two years
Primary	Compliance with treatment in the experimental arm	Number of participants who complete treatment in the experimental arm	two years
Primary	Commencement of treatment by family doctor or self-medication by patients in control arm	Number of control patients who begin treatment for anemia through family physician or self-medication	two years
Secondary	Hemoglobin levels	Hemoglobin levels of both groups at the time of arthroplasty as measured at the pre-operative assessment clinic	two years
Secondary	Change in hemoglobin	Change in hemoglobin level in the experimental arm between first formal assessment and pre-operative assessment clinic	two years
Secondary	Anemia prevelence	Prevalence of anemia at the time of arthroplasty procedure	two years