Pre-Op Anemia Management for Hip Osteoarthritis

Overseen By Isabel Horton

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Must not be taking: Erythropoietin

Disqualifiers: End-stage renal disease, Hematological malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: Varies based on individual treatment plans

800 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this 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.

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are scheduled for primary arthroplasty surgery (hip or knee replacement) and can give informed consent. It's not open to patients with end-stage renal disease, those under a nephrologist's care, receiving erythropoietin treatment, or with hematological conditions already being treated for anemia.

Inclusion Criteria

Willing and able to provide informed consent

I am scheduled for my first joint replacement surgery.

Exclusion Criteria

I have a blood disorder and am receiving treatment for anemia.

I cannot visit the preoperative blood clinic due to kidney disease or treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-operative Assessment

Patients undergo anemia testing at the pre-operative assessment clinic and may seek treatment if anemic

2-4 weeks before surgery

1 visit (in-person)

Experimental Group Testing

Experimental group patients undergo point-of-care anemia testing and formal CBC if thresholds are met

4-6 months before surgery

1 visit (in-person)

Treatment

Anemic patients receive treatment at the Pre-operative Blood Optimization Clinic

Varies based on individual treatment plans

Follow-up

Participants are monitored for safety and effectiveness after treatment

Two years

What Are the Treatments Tested in This Trial?

Interventions

• DiagnosticTest

Trial Overview The study tests if early detection and treatment of anemia before hip or knee replacement surgery improves outcomes. Participants will either follow standard care with anemia testing 2-4 weeks before surgery or be tested at the time they agree to surgery (4-6 months prior), with immediate treatment if needed.

How Is the Trial Designed?

Group I: Experimental - anemia testing Experimental Treatment 1 Intervention

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.

Group II: Control Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Canadian Blood Services

Collaborator

Trials

24

Recruited

39,200+