Clinical trial NCT01676740: Iron and Vitamin Adminstration Prior to Joint Replacement to Prevent Transfusion
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Excessive Amount of Blood / Fluid Transfusion
Keywords: hematinic therapy
blood transfusion
joint replacement
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2012-08-31
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Perioperative blood transfusion
timeFrame: 1 day prior to surgery until hospital discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Medical Center
name: Martin H Ellis, MD
role: PRINCIPAL_INVESTIGATOR
References: