NCT01365104

Brief Summary

The purpose of this study is determine if the iron chelator, desferrioxamine can increase blood levels of hypoxia-inducible transcription factor 1 (HIF-1 protein) and to see if there is a corresponding increase in blood flow to the brain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P75+ for early_phase_1 stroke

Timeline
Completed

Started Mar 2008

Longer than P75 for early_phase_1 stroke

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2008

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 3, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 28, 2015

Status Verified

January 1, 2015

Enrollment Period

4.3 years

First QC Date

May 31, 2011

Last Update Submit

January 26, 2015

Conditions

StrokeProblem of Aging

Keywords

brain blood flowstrokecerebrovascularagingcerebrovascular hemodynamics

Outcome Measures

Primary Outcomes (2)

  • Define change from baseline cerebral blood flow after receiving DFO infusion.

    Cerebral blood flow is measured with transcranial Doppler ultrasound at baseline and then study drug is initiated. Blood flow is measured again after 3 hours of infusion, 6 hours of infusion, then once more 3 hours after the infusion is complete.

    baseline, 3hr, 6hr, 9hr

  • Determine if DFO changes blood HIF-1 levels from baseline and whether this correlates with changes in cerebrovascular hemodynamics.

    Blood samples are taken at each time point and will be correlated with ultrasound blood flow measures taken at baseline, 3hrs of infusion, 6hrs of infusion, and 3 hours after infusion is complete.

    baseline, 3hr, 6hr, 9hr

Study Arms (2)

Healthy young

EXPERIMENTAL

Each subject comes for 2 visits. There is a randomized, double-blind, crossover design so each subject will receive active drug during one visit and placebo during the other.

Drug: desferrioxamine

healthy old

EXPERIMENTAL

Each subject comes for 2 visits. There is a randomized, double-blind, crossover design so each subject will receive active drug during one visit and placebo during the other.

Drug: desferrioxamine

Interventions

desferrioxamineDRUG

intravenous infusion at 10mg/kg/hr for a total of 6 hours at final infused doses of 60mg/kg.

Also known as: Desferal, desferoxamine
Healthy younghealthy old

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy adults between the ages of 18-80 years.

You may not qualify if:

  • subjects taking vasoactive medications,
  • hypertension,
  • pregnant women, smokers,
  • COPD,
  • asthma,
  • diabetes mellitus,
  • intracranial or carotid stenosis,
  • hepatic disease,
  • renal disease,
  • bone marrow suppression,
  • cardiac disease,
  • heart failure,
  • iron deficiency,
  • history of cancer,
  • history of head trauma,
  • +9 more criteria

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)

  • Sorond FA, Tan CO, LaRose S, Monk AD, Fichorova R, Ryan S, Lipsitz LA. Deferoxamine, Cerebrovascular Hemodynamics, and Vascular Aging: Potential Role for Hypoxia-Inducible Transcription Factor-1-Regulated Pathways. Stroke. 2015 Sep;46(9):2576-83. doi: 10.1161/STROKEAHA.115.009906. Epub 2015 Jul 30.

    PMID: 26304864DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Deferoxamine

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Hydroxamic AcidsHydroxylaminesAminesOrganic ChemicalsHydroxy AcidsCarboxylic Acids

Study Officials

  • Farzaneh Sorond, MD, PhD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

May 31, 2011

First Posted

June 3, 2011

Study Start

March 1, 2008

Primary Completion

June 1, 2012

Study Completion

December 1, 2014

Last Updated

January 28, 2015

Record last verified: 2015-01

Locations

US(1)