Iron and Vitamin Adminstration Prior to Joint Replacement to Prevent Transfusion

Excessive Amount of Blood / Fluid Transfusion Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Excessive Amount of Blood / Fluid Transfusion

• NCT number: NCT01676740
• Study type: Interventional
• Source: Meir Medical Center
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2012
• Completion date: February 2014