CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 92 enrolled
Drug / intervention
recombinant activated factor VII +1 moredrug
Likely dose
recombinant activated factor VII 80 mcg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00810888
NCT00810888Phase 2Completed
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The Spot Sign for Predicting and Treating Intracerebral Hemorrhage Growth Study

University of Cincinnati·interventional·Posted Dec 18, 2008·Updated Mar 16, 2018

In Brief

A Phase 2 clinical trial evaluating recombinant activated factor VII and placebo for Intracerebral Hemorrhage. Completed, enrolled 92 participants across 10 sites in 2 countries.

Detailed Summary

The purpose of this study is to determine if computed tomography angiography can predict which individuals with intracerebral hemorrhage will experience significant growth in the size of the hemorrhage. For individuals who are at high risk for hemorrhage growth, the study will compare the drug recombinant activated factor VII (rFVIIa) to placebo to determine the effect of rFVIIa on intracerebral hemorrhage growth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIntracerebral Hemorrhage
CountriesCanada, United States
CollaboratorsNational Institute of Neurological Disorders and Stroke (NINDS)

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 18, 2008
Enrollment StartNov 1, 2010
Primary CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 17.5 years ago

Interventions

recombinant activated factor VIIdrug

Participants will receive rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg).

placebodrug

An inactive substance (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)