Iron and Vitamin Adminstration Prior to Joint Replacement to Prevent Transfusion

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014