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Can Pre-operative Anemia be Timely Identified and Optimized in Patients Awaiting Primary Arthroplasty Surgery? A Randomized Clinical Trial

Primary Purpose

Anemia, Hip Osteoarthritis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Anemia testing
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Ottawa Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental - anemia testing

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
Study Feasibility - Follow-up
Rates of participant follow-up
Compliance with treatment in the experimental arm
Number of participants who complete treatment in the experimental arm
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

Secondary Outcome Measures

Hemoglobin levels
Hemoglobin levels of both groups at the time of arthroplasty as measured at the pre-operative assessment clinic
Change in hemoglobin
Change in hemoglobin level in the experimental arm between first formal assessment and pre-operative assessment clinic
Anemia prevelence
Prevalence of anemia at the time of arthroplasty procedure

Full Information

First Posted
November 23, 2022
Last Updated
December 5, 2022
Sponsor
Ottawa Hospital Research Institute
Collaborators
Canadian Blood Services
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1. Study Identification

Unique Protocol Identification Number
NCT05648942
Brief Title
Can Pre-operative Anemia be Timely Identified and Optimized in Patients Awaiting Primary Arthroplasty Surgery? A Randomized Clinical Trial
Official Title
Can Pre-operative Anemia be Timely Identified and Optimized in Patients Awaiting Primary Arthroplasty Surgery? A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
Canadian Blood Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Hip Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental - anemia testing
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Anemia testing
Intervention Description
Patients will undergo a point of care test to identify possible anemia
Primary Outcome Measure Information:
Title
Feasibility - Enrollment
Description
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.
Time Frame
Two years
Title
Study Feasibility - Follow-up
Description
Rates of participant follow-up
Time Frame
Two years
Title
Compliance with treatment in the experimental arm
Description
Number of participants who complete treatment in the experimental arm
Time Frame
two years
Title
Commencement of treatment by family doctor or self-medication by patients in control arm
Description
Number of control patients who begin treatment for anemia through family physician or self-medication
Time Frame
two years
Secondary Outcome Measure Information:
Title
Hemoglobin levels
Description
Hemoglobin levels of both groups at the time of arthroplasty as measured at the pre-operative assessment clinic
Time Frame
two years
Title
Change in hemoglobin
Description
Change in hemoglobin level in the experimental arm between first formal assessment and pre-operative assessment clinic
Time Frame
two years
Title
Anemia prevelence
Description
Prevalence of anemia at the time of arthroplasty procedure
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isabel Horton
Phone
613-737-8899
Ext
73032
Email
ihorton@ohri.ca
Facility Information:
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Can Pre-operative Anemia be Timely Identified and Optimized in Patients Awaiting Primary Arthroplasty Surgery? A Randomized Clinical Trial

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