Iron and Vitamin Adminstration Prior to Joint Replacement to Prevent Transfusion

Not Applicable

• Conditions: Excessive Amount of Blood / Fluid Transfusion
• Interventions: Drug: Placebo; Drug: Iron Supplement,

• Registration Number: NCT01676740
• Lead Sponsor: Meir Medical Center

Brief Summary

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

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

Study Timeline

• Status Verified: 2012-08
• Study First Submitted: 2012-08-29
• Study First Submitted QC: 2012-08-30
• Study First Posted: 2012-08-31
• Last Update Submitted: 2012-08-31
• Last Update Posted: 2012-09-03
• Study Start: 2012-11
• Primary Completion: 2013-12
• Study Completion: 2014-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mild anemia, normal hematinics	Placebo	Mild anemia, normal iron studies, serum folate and vitamin B12 levels - will receive placebo
Anemia, normal hematinics	Iron Supplement,	Mild anemia, deficient iron, folate or vitamin B12 levels Iron supplement will be given
Deficeicnt hematinics	Iron Supplement,	Iron supplement will be provided

Primary Outcome Measures

Name	Time	Method
Perioperative blood transfusion	1 day prior to surgery until hospital discharge

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel