Iron and Vitamin Adminstration Prior to Joint Replacement to Prevent Transfusion

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

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.

Study Overview

• Status: Unknown
• Conditions: Excessive Amount of Blood / Fluid Transfusion
• Intervention / Treatment: Drug: Placebo; Drug: Iron Supplement,

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Kfar Saba, Israel, 44281
    • Meir Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Mild anemia, normal hematinics; Mild anemia, normal iron studies, serum folate and vitamin B12 levels - will receive placebo	Drug: Placebo; Daily administration of active drug or placebo
EXPERIMENTAL: Anemia, normal hematinics; Mild anemia, deficient iron, folate or vitamin B12 levels Iron supplement will be given	Drug: Iron Supplement,; Pills to be swallowed; Other Names: Ferrifol
OTHER: Deficeicnt hematinics; Iron supplement will be provided	Drug: Iron Supplement,; Pills to be swallowed; Other Names: Ferrifol

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Meir Medical Center
• Investigators: Principal Investigator: Martin H Ellis, MD, Meir Medical Center

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (ANTICIPATED): December 1, 2013
• Study Completion (ANTICIPATED): February 1, 2014

Study Registration Dates

• First Submitted: August 29, 2012
• First Submitted That Met QC Criteria: August 30, 2012
• First Posted (ESTIMATE): August 31, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): September 3, 2012
• Last Update Submitted That Met QC Criteria: August 31, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: blood transfusion; joint replacement; hematinic therapy
• Other Study ID Numbers: MMCHI0112