Pre-Op Anemia Management for Hip Osteoarthritis

N/A

Waitlist Available

Research Sponsored by Ottawa Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up two years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if pre-op anemia tests and treatment can reduce complications and improve outcomes for hip and knee surgery patients.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves testing and potential treatments for pre-operative anemia, side effects may include discomfort from blood draws and reactions to any treatments given to correct anemia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ two years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~two years

This trial's timeline: 3 weeks for screening, Varies for treatment, and two years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Commencement of treatment by family doctor or self-medication by patients in control arm

Compliance with treatment in the experimental arm

Feasibility - Enrollment

+1 more

Secondary study objectives

Anemia prevelence

Change in hemoglobin

Hemoglobin levels

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Experimental - anemia testingExperimental Treatment1 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: ControlActive Control1 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.

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