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Iron and Vitamin Adminstration Prior to Joint Replacement to Prevent Transfusion

This study is not yet open for participant recruitment.
Verified August 2012 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Martin Ellis, Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01676740
First received: August 29, 2012
Last updated: August 31, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention
Excessive Amount of Blood / Fluid Transfusion
 Drug: Iron Supplement,
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Perioperative blood transfusion [ Time Frame: 1 day prior to surgery until hospital discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: November 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: 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

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01676740

Locations
Israel
Meir Medical Center Not yet recruiting
Kfar Saba, Israel, 44281
Contact: Martin H Ellis, MD     972-9-7471822     martinel@clalit.org.il    
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Martin H Ellis, MD Meir Medical Center
  More Information

No publications provided

Responsible Party: Martin Ellis, Head Hematology Institute, Meir Medical Center
ClinicalTrials.gov Identifier: NCT01676740     History of Changes
Other Study ID Numbers: MMCHI0112
Study First Received: August 29, 2012
Last Updated: August 31, 2012
Health Authority: Israel: Clalit Health Services

Keywords provided by Meir Medical Center:
hematinic therapy
blood transfusion
joint replacement

Additional relevant MeSH terms:
Hematinics
Vitamins
Iron
Hematologic Agents
Therapeutic Uses
 Pharmacologic Actions
Micronutrients
Growth Substances
Physiological Effects of Drugs
Trace Elements

ClinicalTrials.gov processed this record on June 18, 2013