Iron and Vitamin Adminstration Prior to Joint Replacement to Prevent Transfusion

Clalit Health Services

Status: Unknown

Conditions: Excessive Amount of Blood / Fluid Transfusion

Treatments: Drug: Iron Supplement,; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01676740

MMCHI0112

Details and patient eligibility

About

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.

Full 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

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups, including a placebo group

Mild anemia, normal hematinics

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Anemia, normal hematinics

Experimental group

Description:

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

Treatment:

Drug: Iron Supplement,

Deficeicnt hematinics

Other group

Description:

Iron supplement will be provided

Treatment:

Drug: Iron Supplement,