The Spot Sign for Predicting and Treating ICH Growth Study
Condition: Intracerebral Hemorrhage
MeSH terms: Cerebral Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Intracerebral hemorrhage (ICH)-breakage of a blood vessel with bleeding in the brain-is a
      devastating form of stroke with a 40-50 percent fatality rate and no proven treatment.
      Because the majority of deaths from ICH occur within several days of the stroke,
      interventions for improving outcomes must occur early in the treatment course. Among the
      potentially modifiable determinants of ICH outcome, hematoma growth is a particularly
      attractive target for intervention and a major focus of this trial.

      The purpose of this study is to determine if an imaging test called computed tomography
      angiography (CTA) can predict which individuals with ICH will experience significant growth
      in the size of the hemorrhage. Growth of the hemorrhage can cause additional injury and may
      worsen the outcome. For individuals who are at high risk for hemorrhage growth based on CTA
      results (i.e., a positive CTA "spot sign," evidence of contrast leakage within the
      hemorrhage), the study will compare the effects of a drug called recombinant activated factor
      VII (NovoSeven®) or rFVIIa with a placebo to determine which is better for reducing ICH
      growth.

      The primary goals of this trial are (1) to determine the sensitivity and specificity of the
      CTA spot sign for predicting hematoma growth; (2) to determine the feasibility of using CTA
      to identify individuals with ICH who are at high risk of hematoma growth and to select study
      participants for randomization to treatment with rFVIIa or placebo; and (3) to determine the
      rate of hematoma growth among spot-positive individuals at 24 hours-comparing individuals
      treated with rFVIIa to those treated with placebo.

      Approximately 184 persons with ICH will be enrolled in one of two study groups at 12 clinical
      sites across the United States and Canada. Participants with ICH who are determined by CTA to
      be at high risk for hemorrhage growth (CTA "spot sign" positive) will be randomized to
      receive either the active study medication, rFVIIa, at 80 mcg/kg, or to receive a placebo (an
      inactive substance). Participants with ICH who are determined by CTA not to be at high risk
      for hemorrhage growth (determined to be CTA "spot sign" negative) will be enrolled into a
      prospective observational group.

      Duration of the study for participants is approximately 3 months.
    

Intervention name(s): recombinant activated factor VII; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg).; An inactive substance (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: intracerebral hemorrhage; ICH; computed tomography angiography; CTA; recombinant activated factor seven; rFVIIa; NovoSeven; recombinant activated factor VII