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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve outcomes for patients undergoing hip or knee surgery by managing anemia (low red blood cell count) before the operation. The researchers plan to test and treat anemia several months before surgery, rather than just a few weeks prior. Some patients will follow the current process, while others will undergo earlier testing with a diagnostic test and, if needed, receive treatment sooner. This trial suits those planning hip or knee replacement surgery who experience frequent tiredness or weakness, which might indicate anemia. As an unphased trial, it offers patients the chance to contribute to innovative approaches in pre-surgical care.

Do I need to stop my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. However, if you have end-stage renal disease or are receiving certain anemia treatments, you may not be eligible to participate.

What prior data suggests that this diagnostic test is safe for pre-operative anemia management?

Research has shown that low blood count (anemia) before surgery can lead to more health problems afterward. Studies have found that anemia is linked to a higher risk of complications and the need for blood transfusions after surgery. To address this, anemia management clinics have been established to check for and treat anemia before surgeries like hip or knee replacements, which can lead to better patient outcomes.

This study tests a new approach that involves early anemia detection using a quick test. This test can identify anemia sooner, allowing patients to start treatment earlier. Previous research suggests that early detection and treatment of anemia can lower the risk of post-surgery complications.

Regarding safety, this method of testing and treating anemia is generally well-tolerated. The goal is to improve hemoglobin levels (a protein in red blood cells) before surgery without introducing new medications or procedures. This approach uses existing screening methods that are safe and commonly used in medical practice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring a new way to manage pre-op anemia in patients with hip osteoarthritis. Unlike the standard practice where anemia is often identified during routine preoperative assessments, this trial uses a point-of-care test to screen patients early on. This approach aims to catch anemia earlier, potentially leading to better preparation and fewer complications during surgery. Plus, this method could reduce the burden on hospital resources by limiting unnecessary tests, which is a significant advantage.

What evidence suggests that this trial's diagnostic test could be effective for managing pre-op anemia in hip osteoarthritis patients?

This trial will compare pre-operative anemia management strategies for patients with hip osteoarthritis. Studies have shown that low blood hemoglobin levels, known as anemia, are common before surgery, affecting about 22% of patients. Anemia before surgery links to worse outcomes, such as increased need for blood transfusions and longer hospital stays. Research indicates that patients with anemia are over eight times more likely to require a blood transfusion during or after surgery. Treating anemia before surgery can reduce these risks and improve recovery. Early testing and treatment of anemia lead to better results for patients undergoing hip and knee surgeries. Participants in the experimental arm of this trial will undergo point-of-care anemia testing, while those in the control arm will follow the current standard pathway without additional testing. ^{2 3 6 7 8}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7418168/

Preoperative Anemia Screening and Treatment Practices ... Patients who had anemia preoperatively were more likely to receive a blood transfusion (odds ratio 8.65 [95% CI 3.98–18.76]) and stayed longer ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11027536/

Impact of preoperative anemia on patients undergoing total ... The prevalence of preoperative anemia is 22% and is associated with poorer postoperative outcomes and increased transfusion volumes and rates.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0883540321009876

Impact of Preoperative Anemia Severity on Primary Total ... This study aims to find a threshold preoperative hemoglobin (Hb) value for increased risk of adverse outcomes in THA.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT01888003

The Benefits of a Preoperative Anemia Management ... The goal of this study is to gain further insight into the comparative effectiveness of treating patients, who are found to be anemic before their elective ...

5. arthroplastyjournal.org arthroplastyjournal.org/article/S0883-5403(21)00987-6/abstract

Impact of Preoperative Anemia Severity on Primary Total ... Preoperative anemia (POA) is a significant predictor for adverse outcomes in primary total hip arthroplasty (THA).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6913451/

Preoperative anemia-screening clinics - PMC - PubMed Central Preoperative anemia is associated with increased postoperative morbidity and mortality and with increased risk of perioperative transfusion.

7. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-024-04706-y

Impact of preoperative anemia on patients undergoing total ... The prevalence of preoperative anemia is 22% and is associated with poorer postoperative outcomes and increased transfusion volumes and rates.

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/trf.14372

Preoperative screening and intervention for mild anemia ... Preoperative anemia in patients undergoing elective hip and knee arthroplasty is associated with increased postoperative morbidity and mortality ...