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NCT Number: NCT05648942

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anemia testing

Diagnostic Test

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

Primary outcomes

  1. Feasibility - Enrollment

    Time frame: Two years

    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.

  2. Study Feasibility - Follow-up

    Time frame: Two years

    Rates of participant follow-up

  3. Compliance with treatment in the experimental arm

    Time frame: two years

    Number of participants who complete treatment in the experimental arm

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

    Time frame: two years

    Number of control patients who begin treatment for anemia through family physician or self-medication

Secondary outcomes

  1. Hemoglobin levels

    Time frame: two years

    Hemoglobin levels of both groups at the time of arthroplasty as measured at the pre-operative assessment clinic

  2. Change in hemoglobin

    Time frame: two years

    Change in hemoglobin level in the experimental arm between first formal assessment and pre-operative assessment clinic

  3. Anemia prevelence

    Time frame: two years

    Prevalence of anemia at the time of arthroplasty procedure

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Collaborators

  • Canadian Blood Services

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 13, 2022
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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