- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02385409
Incidence and Reasons for Preoperative Anemia in Elective Lower Joint Arthroplasty
Incidence and Reasons for Preoperative Anemia in Elective Lower Joint Arthroplasty - A Descriptive Study
Preoperative anemia is an independent risk factor for the need for allogeneic transfusion during surgery and increased postoperative morbidity.
Treatment of preoperative anemia is recommended. However the type of preoperative anemias in elective hip- and knee surgery has only been sparsely studied.
This observational study aims to investigate the incidence and type of anemias prior to elective hip- and knee arthroplasty.
Study Overview
Status
Detailed Description
Preoperative anemia is an independent risk factor for the need for allogeneic transfusion during surgery and increased postoperative morbidity.
In elective orthopedic surgery, international guidelines recommends treatment of preoperative anemia including the use of Iron supplements for anemias associated with iron deficiency. In addition, low iron stores in both anemic and non-anemic patients may delay postoperative hemoglobin recovery.
However, the reasons for preoperative anemia and the prevalence of patients with low iron stores have only been sparsely studied in elective hip- and knee arthroplasty.
This observational study aims to investigate the incidence and type of anemias prior to elective hip- and knee arthroplasty.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Hvidovre, Denmark, 2650
- Hvidovre Hospital, Department of orthopaedic surgery
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age > 18 years
- Scheduled for elective primary hip- or knee replacement.
Exclusion Criteria:
- Not possible to obtain preoperative blood sample.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Elective Total Hip- or Knee arthroplasty patients
Patients scheduled for elective Hip- or knee replacement at Hvidovre Hospital, Denmark.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anemia Classification - Biochemical classification from preoperative venous blood samples
Time Frame: Date of preoperative blood sampling
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Biochemical classification from preoperative venous blood samples
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Date of preoperative blood sampling
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of Anemia according to WHO definitions
Time Frame: Date of preoperative blood sampling
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According to WHO definitions
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Date of preoperative blood sampling
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Proportions of non-anemic patients with low irons stores
Time Frame: Date of preoperative blood sampling
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Low Ferritin or Transferin saturation (TSAT)
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Date of preoperative blood sampling
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Øivind Jans, M.D., Ph.D., Rigshospitalet, Denmark
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RH-4074-OJ5
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