Deferoxamine to Prevent Delayed Cerebral Ischemia After Subarachnoid Hemorrhage

Early Phase 1

Terminated

• Conditions: Subarachnoid Hemorrhage
• Interventions: Drug: desferrioxamine (DFO); Drug: placebo

• Registration Number: NCT02216513
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-06
• Study First Submitted QC: 2014-08-12
• Study First Posted: 2014-08-15
• Study Start: 2014-09
• Primary Completion: 2015-06
• Status Verified: 2015-07
• Study Completion: 2015-07
• Last Update Submitted: 2015-07-17
• Last Update Posted: 2015-07-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Desferrioxamine (DFO)	desferrioxamine (DFO)	DFO (20mg/kg/hr) in normal saline IV for 4 hours for 5 consecutive days
placebo	placebo	normal saline IV for 4 hours for 5 consecutive days

Primary Outcome Measures

Name	Time	Method
delayed cerebral ischemia (DCI)	6 weeks post hemorrhage	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.

Secondary Outcome Measures

Name	Time	Method
Clinical outcome at discharge	patient's discharge date, which averages 3-4 weeks post hemorrhage	Clinical outcome at discharge will be assessed using modified Rankin Scale (mRS) as a global functional status. The modified Rankin scale evaluates global disability and handicap; scores range from 0 (no symptoms or disability) to 6 (death). Good mRS will be defined as score of ≤ 2.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States