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Sanguinate in DCI after SAH
NCT02323685Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2014
- Primary completion
- Jun 2016
- Countries
- 1
- Sponsor
- Prolong Pharmaceuticals
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- Sanguinate
- Conditions
- delayed cerebral ischemia (DCI)
01
Overview
Phase 2, open-label, single-arm trial of Sanguinate in delayed cerebral ischemia (DCI), sponsored by Prolong Pharmaceuticals. Primary endpoints: Safety of study drug at 30 days and Impact of SANGUINATE on brain oxygenation and blood flow at 30 days. Started Dec 2014; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
SANGUINATE™
Single infusion of SANGUINATE (pegylated carboxyhemoglobin)
03
Who it enrols
Patients with aneurysmal subarachnoid hemorrhage (SAH) at risk of delayed cerebral ischemia (DCI), defined by H&H grade 3-4 or WFNS 3-4 and mFisher 3-4, or with symptomatic DCI/angiographic vasospasm. Excludes patients with severe pulmonary or cardiac conditions.
04
Endpoints
Primary
Safety of study drug
Impact of SANGUINATE on brain oxygenation and blood flow
Secondary
National Institutes of Health Stroke Scale
Incidence, location, and size of cerebral infarction
Changes in Blood Gases
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