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hypertonic saline mixed with dextran

Phase 2

Brain Injuries | Small molecule | Other |Unity Biotechnology, Inc.|Last Updated: Apr 9, 2009

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment113
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00878631Feasibility Trial of Traumatic Brain Injured Patients Randomized in the Prehospital Setting to Either Hypertonic Saline and Dextran Versus Normal SalinePHASE2 COMPLETED 113 — — Sep 1, 2004Dec 1, 2008Apr 9, 20092 Canada
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Study Endpoints
Primary Endpoints
baseline survival rates for the treatment and control group to aid in the design of a definitive multicentre trial
survival at 48 hours, hospital discharge, 30 days and 4 months
randomization compliance rate
duration of enrolment
ease of protocol implementation in the out-of-hospital setting
duration of study
adverse event rate of hypertonic saline dextran infusion
duration of study
Secondary Endpoints
neurocognitive outcomes at discharge (cerebral performance category) and at 4 months (functional independence measure, disability rating scale, Glasgow Outcome Scale and Glasgow outcome Scale Extended
discharge and at 4 months post incident
neuropsychological outcomes including learning and memory, working memory, executive function, language function, visuospatial function, speed of processing and Beck Depression Scale. A focused attention reaction time test was added to 12 month testing.
at 4 and 12 months post incident
magnetic resonance imaging to evaluate effects of HSD on brain atrophy post-injury
4 months post incident
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1 Normal SalineACTIVE_COMPARATORinfusion of 250 ccs of Normal Saline within 4 hours of the accident
2 - hypertonic saline mixed with dextranEXPERIMENTALa single dose 250 ml of 7.5% hypertonic saline in 6% dextran 70 infused within 4 hours of the accident
Interventions
NameTypeDescription
hypertonic saline mixed with dextranDRUGa single dose 250 ml of 7.5% hypertonic saline in 6% dextran 70 is given within 4 hours from the time of the accident
Normal SalineDRUG250 ccs of normal saline infused within 4 hours of the accident
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Eligibility Criteria
Age Range16 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Age ≥ 16; * Initial assessment of GCS 8 or less; * Blunt traumatic mechanism of injury. Exclusion Criteria: * Known pregnancy; * Primary injury penetrating; * VSA prior to randomization; * Previous Intravenous therapy ≥ 50 ml; * Time interval between arrival at scene and int...

Countries:Canada
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