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The Safety of a High-Dose, Rapid Infusion of Iron Sucrose

NCT ID: NCT02977611

Last Updated: 2017-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-05-31

Brief Summary

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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

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Conditions

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Iron Deficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High Dose, Rapid Infusion Iron Sucrose

Patients will receive an infusion of 500 mg of iron sucrose over one hour and will be monitored for four hours.

Group Type EXPERIMENTAL

Iron sucrose

Intervention Type DRUG

Iron sucrose will be infused at dose of 500 mg over a one hour period

Interventions

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Iron sucrose

Iron sucrose will be infused at dose of 500 mg over a one hour period

Intervention Type DRUG

Other Intervention Names

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Venofer

Eligibility Criteria

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Inclusion Criteria

* Any patient requiring iron infusion

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Guthrie Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bradley Lash, MD

Role: PRINCIPAL_INVESTIGATOR

The Guthrie Clinic

Locations

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Robert Packer Hospital

Sayre, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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1611-56

Identifier Type: -

Identifier Source: org_study_id