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The Spot Sign for Predicting and Treating ICH Growth Study

NCT00810888 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2018-03-16

Study results available
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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.

Conditions

  • Intracerebral Hemorrhage

Interventions

DRUG

recombinant activated factor VII

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

DRUG

placebo

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

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • University of Cincinnati

    lead OTHER

Principal Investigators

  • Matthew L. Flaherty, MD · University of Cincinnati

  • Edward C. Jauch, MD, MS · Primary Emergency Medicine Investigator, Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00810888 on ClinicalTrials.gov