Iron and Vitamin Adminstration Prior to Joint Replacement to Prevent Transfusion

NCT ID: NCT01676740

Last Updated: 2012-09-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-02-28

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.

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

Conditions

Excessive Amount of Blood / Fluid Transfusion

Keywords

hematinic therapy; blood transfusion; joint replacement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Mild anemia, normal hematinics

Mild anemia, normal iron studies, serum folate and vitamin B12 levels - will receive placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Daily administration of active drug or placebo

Anemia, normal hematinics

Mild anemia, deficient iron, folate or vitamin B12 levels Iron supplement will be given

Group Type: EXPERIMENTAL

Iron Supplement,

Intervention Type: DRUG

Pills to be swallowed

Deficeicnt hematinics

Iron supplement will be provided

Group Type: OTHER

Iron Supplement,

Intervention Type: DRUG

Pills to be swallowed

Interventions

Iron Supplement,

Pills to be swallowed

Intervention Type: DRUG

Placebo

Daily administration of active drug or placebo

Intervention Type: DRUG

Other Intervention Names

Ferrifol

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Martin Ellis

Head Hematology Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin H Ellis, MD

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center

Locations

Meir Medical Center

Kfar Saba, , Israel

Countries

Israel

Facility Contacts

Martin H Ellis, MD

Role: primary

Other Identifiers

MMCHI0112

Identifier Type: -

Identifier Source: org_study_id