NCT02216513

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Sep 2014

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 15, 2014

Completed
17 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

July 21, 2015

Status Verified

July 1, 2015

Enrollment Period

9 months

First QC Date

August 6, 2014

Last Update Submit

July 17, 2015

Conditions

Subarachnoid Hemorrhage

Keywords

subarachnoid hemorrhageSAHDFOcerebral autoregulationdelayed cerebral ischemia

Outcome Measures

Primary Outcomes (1)

  • delayed cerebral ischemia (DCI)

    DCI will be defined radiographically as any cerebral infarct on the latest CT scan that was seen within 6 weeks after SAH or before discharge or death, that was not present on admission scan or on the CT scan done within 24 to 48 hours after any aneurysmal treatment procedures. All head CT scans will be reviewed for DCI ascertainment by neuroradiologists blinded to the clinical and TCD data using the standardized protocol.

    6 weeks post hemorrhage

Secondary Outcomes (1)

  • Clinical outcome at discharge

    patient's discharge date, which averages 3-4 weeks post hemorrhage

Other Outcomes (1)

  • Cerebrovascular function (i.e., cerebral autoregulation)

    5 days after initiation of study drug

Study Arms (2)

Desferrioxamine (DFO)

ACTIVE COMPARATOR

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

Drug: desferrioxamine (DFO)

placebo

PLACEBO COMPARATOR

normal saline IV for 4 hours for 5 consecutive days

Drug: placebo

Interventions

desferrioxamine (DFO)DRUG

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

Also known as: deferoxamine, desferal, DFO, deferoxamine mesylate
Desferrioxamine (DFO)
placeboDRUG

normal saline IV for 4 hours for 5 consecutive days

Also known as: normal saline NS
placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • 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.

    PMID: 33236783DERIVED

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

DeferoxamineSaline Solution

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxamic AcidsHydroxylaminesAminesOrganic ChemicalsHydroxy AcidsCarboxylic AcidsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Farzaneh A Sorond, MD, PhD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BWPO Physician

Study Record Dates

First Submitted

August 6, 2014

First Posted

August 15, 2014

Study Start

September 1, 2014

Primary Completion

June 1, 2015

Study Completion

July 1, 2015

Last Updated

July 21, 2015

Record last verified: 2015-07

Locations

US(1)