STOP-IT
The Spot Sign for Predicting and Treating ICH Growth Study [SPOTRIAS]
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Status:
This study is not yet open for participant recruitment.
Purpose:
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.
Location(s):
United States
Canada
Year Started:
2009
Design:
Interventional, Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study.
Inclusion Criteria
Acute, spontaneous ICH (including bleeding in cerebellum) diagnosed by non-enhanced CT scan within five hours of symptom onset. (Time of onset is defined as the last time the patient was witnessed to be at baseline (i.e., subjects who have stroke symptoms upon awakening will be considered to have their onset at beginning of sleep); for spot positive patients, dosing of study drug within 90 minutes of enrolling CT scan.
Exclusion Criteria
Time of symptom onset of ICH is unknown or more than five hours prior to baseline CT scan, ICH secondary to known or suspected trauma, aneurysm, vascular malformation, hemorrhagic conversion of ischemic stroke, venous sinus thrombosis, thrombolytic treatment of any condition (e.g., myocardial infarction, cerebral infarction, etc.), CNS tumor or CNS infection; brainstem location of hemorrhage (patients with cerebellar hemorrhage may be enrolled); Serum creatinine > 1.4 mg/dl (123 μmol/L). Sites that currently perform CTA as standard of care for ICH will follow their standard procedures regarding renal insufficiency; known allergy to iodinated contrast media; intravenous or intra-arterial administration of iodinated contrast media within the previous 24 hours of baseline CT scan; known hereditary (e.g., hemophilia) or acquired hemorrhagic diathesis, coagulation factor deficiency, or anticoagulant therapy with INR > 1.2; known or suspected thrombocytopenia (unless current platelet count documented above 50,000 / μl); unfractionated heparin use with abnormal PTT; low-molecular weight heparin use within the previous 24 hours; GPIIb/IIIa antagonist use in the previous two weeks; Glasgow Coma Scale score < 8 at time of proposed enrollment; Pre-admission modified Rankin Scale score > 2; Baseline ICH volume of < 0.5 cc (Hematoma volume will be estimated by local investigators from the baseline CT using the ABC / 2 method.); baseline ICH volume of > 90 cc; planned surgical evacuation of ICH within 24 hours of symptom onset (Placement of intraventricular catheter is not a contraindication to study enrollment.); recent (within 90 days) myocardial infarction, coronary artery bypass surgery, unstable angina, transient ischemic attack, ischemic stroke, cerebral bypass surgery, carotid endarterectomy, deep venous thrombosis, pulmonary embolism, or coronary or cerebrovascular angioplasty or stenting; baseline electrocardiogram shows evidence of acute cardiac ischemia (ST elevation in two contiguous leads, new LBBB, or ST depression); clinical history suggestive of acute cardiac ischemia (e.g., chest pain); abnormal baseline troponin; pregnancy or lactating; advanced or terminal illness or any other condition the investigator feels would pose a significant hazard to the patient if rFVIIa were administered; recent (within 30 days) participation in any investigational drug or device trial or earlier participation in any investigational drug or device trial for which the duration of effect is expected to persist until the time of STOP-IT enrollment; planned withdrawal of care or comfort care measures.
Patient Involvement:
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 but otherwise meeting the same criteria) will be enrolled into a prospective observational group. Participants will have a baseline head CT scan within 5 hours, followed by a CT angiogram. Hematoma growth determined by comparison with a head CT scan performed at 24 hours. Follow up will be done in 3 months.
Primary Outcome:
Life-threatening thromboembolic complications defined as development of (1) acute myocardial ischemia; (2) acute cerebral ischemia; and (3) acute pulmonary embolism; rate of hematoma growth among spot sign positive subjects at 24 hours, comparing subjects treated with rFVIIa to those treated with placebo. Hematoma growth will be defined as a > 33% or > 6 cc increase in volume; sensitivity and specificity of the spot sign for predicting hematoma growth.
Secondary Outcome:
Incidence of other potentially study drug related thromboembolic complications such as deep venous thrombosis and elevations in troponin not associated with ECG changes; ninety-day outcomes among spot positive subjects, dichotomized as modified Rankin Scale score of 0-4 verses 5-6, comparing subjects treated with rFVIIa to those treated with placebo; positive and negative predictive values of the spot sign and the accuracy of the site investigators for correct identification of the spot sign as compared to a blinded study neuroradiologist.
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Source of Information:
Abstract from ISC 2009.
ClinicalTrials.gov
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Web Links and Publications:
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This information last updated on: 9/29/2009
Reviewed on: 09/08/2009.
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