Preoperative treatment of anemia with iron sucrose (Venofer) plus Epoetin Alfa (Eprex)

Preoperative treatment of anemia with iron sucrose (Venofer) plus placebo (saline)

Anemia, Iron Deficiency

Anemia of Chronic Disease

Hip Arthropathy

Knee Arthropathy

Intravenous iron to be administered to all patients (9 x 5 mL Single Dose Vials @ 20mg elemental iron/mL; 900 mg total)

Iron sucrose

Erythropoietin to be administered to half of study participants (40,000 IU x 1-2 subcutaneous injections)

Epoetin Alfa

Saline to be administered to half of study participants (equal volume to Eprex x 1-2 subcutaneous injections)

Placebo

St. Michael's Hosptial

Hemoglobin Optimization to Prevent Transfusion and Adverse Events in Perioperative Patients With Iron Restricted Anemia

A Randomized Double-Blinded Phase II Study to Determine Treatment Protocol for Hemoglobin Optimization to Prevent Transfusion and Adverse Events in Perioperative Patients With Iron Restricted Anemia

The primary outcome of the vanguard phase is to determine the feasibility of using erythropoietin + intravenous iron to treat preoperative iron restrictive anemia. Feasibility will be measured according to subject enrollment rates, with adherence to the treatment schedule of >80%.

The primary outcome of the full study is preoperative hemoglobin concentration, as measured on the day of surgery in patients with iron restricted anemia.

Change in post-treatment hemoglobin concentration from baseline

Rate of hemoglobin change from initiation of treatment to final preoperative hemoglobin

Hemoglobin concentration on postoperative day 2 (prior to hospital discharge); and 4-6 weeks after surgery

Rate of RBC transfusion and number of units transfused during surgery and up to 6 weeks postoperatively

Incidence of DVT up to 12 weeks postoperatively

Incidence of a composite clinical outcome including death, stroke, myocardial infarction, pulmonary embolism, infection, acute kidney injury, and deep vein thrombosis from treatment to up to 3 months post surgery

Incidence of superficial and deep wound infection from treatment to 4-6 weeks post surgery

Hematological outcomes for treatment efficacy including: Hb, ferritin, hepcidin, and transferrin saturation (TSAT) pre-operatively and 4-6 weeks postoperatively

Cognitive assessment of word learning, recall and recognition, as well as episodic memory

A subjective cognitive assessment of cognitive functioning. This is a 95-item questionnaire, with all items rated on a scale from 0 (not at all) to 5 (extremely). From the 95 total items, 80 items describe neurophysiological symptoms (Global measure of impairment; GMI), 10 items describe affective disturbance, and 5 items assess test-taking attitudes. A total GMI score can range from 0-320, with higher scores indicating an increased impairment index.

Cognitive assessment of response speed, sustained attention, and visual spatial skills

Cognitive assessment of global cognitive functioning

Cognitive assessment of a participant's ability to set-shift (display flexibility in the face of changing conditions)

Cognitive assessment of anxiety and depression levels. A total score between 0-7 indicates normal levels of depression or anxiety; a total score between 8-10 indicates borderline abnormal levels of anxiety or depression; and a total score between 11-21 indicates abnormal levels of depression or anxiety

Assessment of relative cost of treatment and cost savings associated with transfusion avoidance will be assessed (see projected cost analysis; appended)

St. Michael's Hospital, Toronto

Take two capsules, twice daily before breakfast and dinner

Blood Pressure

Onion-Pumpkin Extract

The Effects of the Onion-Pumpkin Extract on Blood Pressure

The Effects of the Onion-Pumpkin Extract on Blood Pressure: An Open-label, Adaptive-design, Pilot Study

Medicus Research, LLC

replace high fat, energy dense foods with foods rich in whole grains, fruits and vegetables. The macronutrient distribution of this diet will be approximately 55% carbohydrate, 15% protein and 30% fat. Individuals will also be instructed to reduce sodium intake to < 2300 mg / day and in individuals with hypertension, < 1500 mg / day.

restrict carbohydrate consumption to < 20 grams / day while not restricting caloric intake. Participants will be encouraged to consume vegetables with low carbohydrate content every day including 2 cups of salad greens and 1 cup of vegetables 'that grow above the ground' to increase their salt intake by consuming two cups of broth , ½ teaspoon of salt, or tablespoons of salt daily

Metabolic Syndrome

restrict carbohydrate consumption to < 20 grams / day while not restricting their caloric intake. Participants will be encouraged to consume vegetables with low carbohydrate content every day including 2 cups of salad greens and 1 cup of vegetables 'that grow above the ground' increase their salt intake by consuming two cups of broth , ½ teaspoon of salt, or tablespoons of salt daily

Low carbohydrate diet

St. Paul's Hospital

The ACT-OUT Trial: ACTivity OUTcomes Based on High Carbohydrate or High Fat Diet in Metabolic Syndrome

The ACT-OUT Trial: ACTivity OUTcomes Based on the Consumption of a High Carbohydrate or High Fat Diet in Patients With Metabolic Syndrome

activity counts per minute;
time spent in light and moderate to vigorous physical activity;
activity based energy expenditure using previously validated equations

total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, apolipoprotein B, apolipoprotein A1

sucrose/infarkt

Hemoglobin Optimization to Prevent Transfusion and Adverse Events in Perioperative Patients With Iron Restricted Anemia

The Effects of the Onion-Pumpkin Extract on Blood Pressure

The ACT-OUT Trial: ACTivity OUTcomes Based on High Carbohydrate or High Fat Diet in Metabolic Syndrome

Honolulu Heart Program

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