Deferoxamine to Prevent Delayed Cerebral Ischemia After Subarachnoid Hemorrhage

NCT ID: NCT02216513

Last Updated: 2015-07-21

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

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-07-31

Brief Summary

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The investigators will test the central hypothesis that DFO treatment after SAH may improve cerebrovascular regulation, mitigate ischemic neural injury, and serve as an effective neuroprotectant against delayed ischemic injury after SAH.

Detailed Description

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Conditions

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Subarachnoid Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Desferrioxamine (DFO)

DFO (20mg/kg/hr) in normal saline IV for 4 hours for 5 consecutive days

Group Type ACTIVE_COMPARATOR

desferrioxamine (DFO)

Intervention Type DRUG

DFO (20mg/kg/hr) in normal saline for 4 hours for 5 consecutive days

placebo

normal saline IV for 4 hours for 5 consecutive days

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

normal saline IV for 4 hours for 5 consecutive days

Interventions

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desferrioxamine (DFO)

DFO (20mg/kg/hr) in normal saline for 4 hours for 5 consecutive days

Intervention Type DRUG

placebo

normal saline IV for 4 hours for 5 consecutive days

Intervention Type DRUG

Other Intervention Names

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deferoxamine, desferal, DFO, deferoxamine mesylate normal saline NS

Eligibility Criteria

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Inclusion Criteria

* diagnosis of spontaneous SAH
* impaired cerebral autoregulation on day 2-4 post SAH

Exclusion Criteria

* traumatic SAH
* other central neurological disorders such as tumors, known prior stroke, hemorrhage or vascular malformations
* pregnancy
* severe renal disease or anuria
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Jeffrey Thomas Stroke Shield Foundation

UNKNOWN

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Farzaneh Sorond

BWPO Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Farzaneh A Sorond, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Van der Loo LE, Aquarius R, Teernstra O, Klijn K, Menovsky T, van Dijk JMC, Bartels R, Boogaarts HD. Iron chelators for acute stroke. Cochrane Database Syst Rev. 2020 Nov 24;11(11):CD009280. doi: 10.1002/14651858.CD009280.pub3.

Reference Type DERIVED
PMID: 33236783 (View on PubMed)

Other Identifiers

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2014P001400

Identifier Type: -

Identifier Source: org_study_id

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