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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05648942
Enrollment
800
Registered
2022-12-13
Start date
2023-01-23
Completion date
2026-08-01
Last updated
2026-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Hip Osteoarthritis

Brief 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.

Interventions

DIAGNOSTIC_TESTAnemia testing

Patients will undergo a point of care test to identify possible anemia

Sponsors

Ottawa Hospital Research Institute
Lead SponsorOTHER
Canadian Blood Services
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility - EnrollmentTwo yearsNumber 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.
Study Feasibility - Follow-upTwo yearsRates of participant follow-up
Compliance with treatment in the experimental armtwo yearsNumber of participants who complete treatment in the experimental arm
Commencement of treatment by family doctor or self-medication by patients in control armtwo yearsNumber of control patients who begin treatment for anemia through family physician or self-medication

Secondary

MeasureTime frameDescription
Hemoglobin levelstwo yearsHemoglobin levels of both groups at the time of arthroplasty as measured at the pre-operative assessment clinic
Change in hemoglobintwo yearsChange in hemoglobin level in the experimental arm between first formal assessment and pre-operative assessment clinic
Anemia prevelencetwo yearsPrevalence of anemia at the time of arthroplasty procedure

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 3, 2026