Iron and Vitamin Adminstration Prior to Joint Replacement to Prevent Transfusion

Study Overview
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Brief Summary
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To establish the efficacy of screening for anemia and treatment of mild anemia with iron and vitamins prior to THR and TKR as a means of increasing hemoglobin and reducing perioperative allogeneic blood transfusion.

Detailed Description
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Patients with mild anemia will be identified at preoperative clinic visit Patients will be screened for inclusion and exclusion criteria Eligible patients will have laboratory testing performed as follows: CBC, liver and kidney function tests, serum iron, transferrin, ferritin, serum folic acid, vitamin B12 and C-reactive protein Patients will be assigned to a deficient group or non-deficient group depending upon laboratory hematinic values Patients in the non-deficient' group will be randomized using a computer-generated code to treatment or no treatment Treatment will begin within 2 weeks of laboratory testing and 4-6 weeks prior to surgery. Hematinic therapy will consist of oral ferric hydrochloride polymaltose 200 mg/d and folic acid 0.4 mg/d; sublingual vitamin B12 1000 µg three times a week On the day of surgery laboratory testing will be performed as follows: CBC, kidney and liver function tests, serum iron, transferrin, ferritin, serum folic acid, vitamin B12 and C-reactive protein. The same surgical team in each center will operate on all study patients and will be blinded to the preoperative hemoglobin Routine postoperative management will be provided as determined by the treating physicians Blood transfusion will be decided upon by a study physician at each center blinded to the patients' group assignment and preoperative hemoglobin The primary outcome will be perioperative blood transfusion (from 24 hours prior to surgery until hospital discharge) Secondary outcomes will be length of hospitalization, postoperative wound infection, walking ability across room at 30 days

Official Title
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Randomized Ttrial to Establish the Efficacy of Hematinic Agents in Patietns With Mild Anemia Undergoing Total Hip or Knee Replacement in Avoiding Blood Transfusion

Conditions
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Excessive Amount of Blood / Fluid Transfusion

Intervention / Treatment
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* Drug: Iron Supplement,
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 50 years Ability to provide informed consent Elective THR or TKR Mild anemia: Hematocrit 29-39% in men, 29-36% in women Exclusion Criteria: Identified cause of anemia excluding hematinic deficiency Known source of blood loss Known coagulopathy Unstable coronary syndrome in the previous 3 months Pathologic fracture, presence of malignancy Repeat THR or TKR Orthopedic trauma within the previous 3 months ASA class ≥ 4 Creatinine clearance < 30 ml/min AST/ALT > 2x upper limit of normal Preexisting use of hematinic agents Planned acute normovolemic hemodilution Refusal to receive blood products

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Mild anemia, normal hematinics<br>Mild anemia, normal iron studies, serum folate and vitamin B12 levels - will receive placebo | Drug: Placebo<br>* Daily administration of active drug or placebo<br>|
| Experimental: Anemia, normal hematinics<br>Mild anemia, deficient iron, folate or vitamin B12 levels Iron supplement will be given | Drug: Iron Supplement,<br>* Pills to be swallowed<br>* Other names: Ferrifol;|
| Other: Deficeicnt hematinics<br>Iron supplement will be provided | Drug: Iron Supplement,<br>* Pills to be swallowed<br>* Other names: Ferrifol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative blood transfusion |  | 1 day prior to surgery until hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hematinic therapy, blood transfusion, joint replacement