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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anemia; Hip Osteoarthritis
• Intervention / Treatment: Diagnostic test: Anemia testing

• Study Type: Interventional
• Enrollment (Anticipated): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Isabel Horton; Phone Number: 73032 613-737-8899; Email: ihorton@ohri.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental - anemia testing; All patients in the experimental group will undergo a point of care test. Patients who meet the higher point-of-care-testing thresholds as possibly having anemia (female: 130g/L; male: 140g/L) will have a formal complete blood count (CBC) test. Formal CBC will not be ordered for all patients in the experimental group to limit the burden on hospital resources. The study co-ordinator will review CBC levels and contact patients to inform them of their results. Patients identified as having anemia in the formal CBC test will be invited to be reviewed in the PBOC. Patients in the experimental group who do not meet the threshold for possible anemia on the point-of-care test will continue the current pathway and be reassessed in the preoperative assessment clinic at the time of scheduled surgery. Patients in the experimental group who are determined not to have anemia after formal CBC tests will follow the same pathway.	Diagnostic test: Anemia testing; Patients will undergo a point of care test to identify possible anemia
No Intervention: Control; Patients in the control group will not be tested at point of care and will continue on the current pathway and be assessed in the preoperative assessment clinic at the time of scheduled surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Study Feasibility - Follow-up	Rates of participant follow-up	Two years
Compliance with treatment in the experimental arm	Number of participants who complete treatment in the experimental arm	two years
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin levels	Hemoglobin levels of both groups at the time of arthroplasty as measured at the pre-operative assessment clinic	two years
Change in hemoglobin	Change in hemoglobin level in the experimental arm between first formal assessment and pre-operative assessment clinic	two years
Anemia prevelence	Prevalence of anemia at the time of arthroplasty procedure	two years

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Collaborators: Canadian Blood Services

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: November 23, 2022
• First Submitted That Met QC Criteria: December 5, 2022
• First Posted (Estimate): December 13, 2022

Study Record Updates

• Last Update Posted (Estimate): December 13, 2022
• Last Update Submitted That Met QC Criteria: December 5, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Anemia; Osteoarthritis, Hip
• Other Study ID Numbers: 20200795-01H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No