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Iron and Vitamin Adminstration Prior to Joint Replacement to Prevent Transfusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01676740
Recruitment Status : Unknown
Verified August 2012 by Martin Ellis, Meir Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 31, 2012
Last Update Posted : September 3, 2012
Information provided by (Responsible Party):
Martin Ellis, 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.

Condition or disease Intervention/treatment Phase
Excessive Amount of Blood / Fluid Transfusion Drug: Iron Supplement, Drug: Placebo Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : November 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

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 Name: Ferrifol

Deficeicnt hematinics
Iron supplement will be provided
Drug: Iron Supplement,
Pills to be swallowed
Other Name: Ferrifol

Primary Outcome Measures :
  1. Perioperative blood transfusion [ Time Frame: 1 day prior to surgery until hospital discharge ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01676740

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Meir Medical Center
Kfar Saba, Israel, 44281
Contact: Martin H Ellis, MD    972-9-7471822   
Sponsors and Collaborators
Meir Medical Center
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Principal Investigator: Martin H Ellis, MD Meir Medical Center
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Responsible Party: Martin Ellis, Head Hematology Institute, Meir Medical Center Identifier: NCT01676740    
Other Study ID Numbers: MMCHI0112
First Posted: August 31, 2012    Key Record Dates
Last Update Posted: September 3, 2012
Last Verified: August 2012
Keywords provided by Martin Ellis, Meir Medical Center:
hematinic therapy
blood transfusion
joint replacement