AnemiaNCT05648942
Can Pre-operative Anemia be Timely Identified and Optimized in Patients Awaiting Primary Arthroplasty Surgery? A Randomized Clinical Trial
A study testing Anemia testing in people with Anemia and Hip Osteoarthritis, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Hip Osteoarthritis
- What is being tested?
- Anemia testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteCanada
- Study dates
- 23 Jan 2023to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age
- Undergoing primary arthroplasty procedure
- Willing and able to provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Anemia, Hip Osteoarthritis
- Being tested
- Anemia testing
- Medical subject headings
- Anemia, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anemia testingDiagnostic test
Patients will undergo a point of care test to identify possible anemia
| Study group | Role | What they receive |
|---|---|---|
| Experimental - anemia testing | Experimental | 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. Receives: Diagnostic Test: Anemia testing |
| Control | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two years
Study Feasibility - Follow-up
Rates of participant follow-up
Measured: Two years
Compliance with treatment in the experimental arm
Number of participants who complete treatment in the experimental arm
Measured: 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
Measured: two years
Secondary outcomes (3)
Hemoglobin levels
Hemoglobin levels of both groups at the time of arthroplasty as measured at the pre-operative assessment clinic
Measured: two years
Change in hemoglobin
Change in hemoglobin level in the experimental arm between first formal assessment and pre-operative assessment clinic
Measured: two years
Anemia prevelence
Prevalence of anemia at the time of arthroplasty procedure
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start23 Jan 2023
- Primary completion1 May 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Blood Services
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648942
- Sponsor's protocol ID
- 20200795-01H
- Status last verified
- Aug 2026
- First submitted
- 23 Nov 2022
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Pre-operative Anemia be Timely Identified and Optimized in Patients Awaiting Primary Arthroplasty Surgery? A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05648942
- Acronym / sponsor ID
- 20200795-01H
- Conditions
- Anemia, Hip Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Blood Services
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 13 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental - anemia testing | Experimental | Diagnostic Test: Anemia testingAll 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. |
| Control | No 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age
- Undergoing primary arthroplasty procedure
- Willing and able to provide informed consent
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anemia testingPatients will undergo a point of care test to identify possible anemia | Diagnostic test | Experimental - anemia testing |
Primary outcome
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.
Study Feasibility - Follow-up
Time frame: Two years
Rates of participant follow-up
Compliance with treatment in the experimental arm
Time frame: two years
Number of participants who complete treatment in the experimental arm
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
3 secondary outcomes
Hemoglobin levels
Time frame: two years
Change in hemoglobin
Time frame: two years
Anemia prevelence
Time frame: two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anemia testing in people with Anemia and Hip Osteoarthritis, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - Enrollment (time frame: Two years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.