The Safety of a High-Dose, Rapid Infusion of Iron Sucrose
- Registration Number
- NCT02977611
- Lead Sponsor
- The Guthrie Clinic
- Brief Summary
Iron sucrose infusion is an iron replacement used to treat iron deficiency anemia (not enough iron in the body to make hemoglobin). Iron is a mineral that the body needs to produce hemoglobin, which carries oxygen in the blood. When the body does not get enough iron, it cannot produce enough hemoglobin and you become anemic.
The research study is looking at the side effects of using a higher dose and faster rate of iron sucrose infusion than what is used in standard of care. The purpose of this study is to see if infusion with 500 mg of iron sucrose over a one hour time period can be done safely. If this can be done safely, it may reduce the total number of infusions required and the time for each infusion. This may be less costly and less burdensome to patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Any patient requiring iron infusion
- Patients will be excluded from enrollment if they are under the age of 18, unable to give signed consent, are pregnant, have end-stage renal disease, are on hemodialysis (HD), or have a history of clinically significant adverse reactions to iron sucrose.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description High Dose, Rapid Infusion Iron Sucrose Iron sucrose Patients will receive an infusion of 500 mg of iron sucrose over one hour and will be monitored for four hours.
- Primary Outcome Measures
Name Time Method incidence of adverse events in the study population attributed to drug administration. 4 hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Robert Packer Hospital
🇺🇸Sayre, Pennsylvania, United States
Robert Packer Hospital🇺🇸Sayre, Pennsylvania, United States