iDef (Intracerebral Hemorrhage Deferoxamine Trial)

Site Primary Investigator (UMASS): Susanne Muehlschlegel, MD MPH

Other Primary Investigator: Magdy Selim, MD PhD; (BIDMC Boston)

Design: Prospective multi-center, placebo controlled, randomized controlled phase II trial exploring efficacy and safety of Deferoxamine Mesylate

Background: Iron from degraded hemoglobin is linked to delayed neuronal injury after an intracerebral hemorrhage (ICH). Currently no treatments exist for spontaneous ICH beyond supportive medical care. Potentially, Deferoxamine is a promising neuroprotective agent to target the secondary ICH effects.

Funding: National Institute of Health/National Institute for Neurological Diseases and Stroke (NIH/NINDS); U01 NS074425

Objectives

•Primary Objective:

-To assess the futility of using Deferoxamine as a therapeutic intervention for ICH into Phase III evaluation

•Secondary Objectives:

- To assess the safety of Deferoxamine infusions

Outcome measures:  Improvement of mRS at day 90 (modified Rankin Scale), and safety of Deferoxamine.

Anticipated study duration: Completed enrollment in Nov 2017

Anticipated patient enrollment: Total of 294 patients to be recruited nationally.

Patient enrollment at UMASS: UMASS enrolled and randomized 17 patients and was 5th highest enroller study-wide

UMASS IRB docket number: H00000513