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Neurovascular Complications and White Matter Damage in Acquired Anemias

2020-03-28 03:55:33 | BioPortfolio

Summary

This is an observational trial, with an interventional arm, in patients with moderate to severe anemia and control subjects. The main purpose of this study is to understand whether normal brain blood flow, oxygen extraction reserve, white matter volumes, and brain functional connectivity are affected by acquired anemia. We will perform baseline MRI monitoring for all subjects. Subjects with confirmed iron defiency will be offered intravenous iron therapy. Repeat MRI will be performed twice following iron replacement therapy. All eligible subjects will be asked to provide informed consent before participating in the study.

Description

This is an observational trial, with an interventional arm, in patients with moderate to severe anemia and control subjects. The main purpose of this study is to understand whether normal brain blood flow, oxygen extraction reserve, white matter volumes, and brain functional connectivity are affected by acquired anemia. We will perform baseline MRI monitoring for all subjects. Subjects with confirmed iron defiency will be offered intravenous iron therapy. Repeat MRI will be performed twice following iron replacement therapy. All eligible subjects will be asked to provide informed consent before participating in the study.

Treatment:

All subjects, anemic and control, will undergo baseline phlebotomy, brain MRI, and neurocognitive testing. All patients with hemoglobin less than 11 g/dl will undergo carboxymaltose iron replacement according to package insert guidelines. This consists of two doses of 15 mg/kg given (max individual dose 750 mg) at least 7 days apart. The drug is administered as an infusion over 30 minutes. Patients will undergo symptom and vital sign monitoring for 30 minutes per guidelines. Repeat MRI and blood work will be performed at 3 months and 12 months following iron replacement, and repeat neurocognitive testing will be performed 12 months following iron replacement.

Safety Assessment:

All MRI experiments will be monitored by a trained technician or physician. Ferric carboxymaltose preparation will be diluted with 250 ml of normal saline and infused at half the manufacturer's suggested infusion rate (over 30 minutes). Vital signs and symptoms will be assessed at baseline, 5', 15', and 30' post infusion completion. Infusions will be performed in an environment with full resuscitation capability by trained nursing personnel, supervised by a physician or nurse practitioner trained in managing hypersensitivity reactions. Subjects who receive ferric carboxymaltose will have study visits at 3 months and 12 months with monitoring of complete blood count, hemoglobin, and vital signs. Adverse events will be assessed at every study visit after the first dose through to the last subject visit.

Efficacy Assessment:

Comprehensive cerebrovascular MRI, baseline bloodwork, and neurocognitive testing will be collected from all subjects. Anemic patients receiving intervention will have repeated MRI and bloodwork at 3 months and 12 months following the intervention, and repeat neurocognitive testing will be performed at study termination.

Study Design

Conditions

Anemia

Intervention

Ferric carboxymaltose

Location

Children's Hospital Los Angeles
Los Angeles
California
United States
90027

Status

Not yet recruiting

Source

Children's Hospital Los Angeles

Results (where available)

View Results

Links

Published on BioPortfolio: 2020-03-28T03:55:33-0400

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