THE SPOT SIGN FOR PREDICTING AND TREATING ICH GROWTH TRIAL (STOP-IT STUDY)

Study ID
STU 112010-060

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Parkland Health & Hospital System

Contact
Katrina van de Bruinhorst
214-648-9248
katrina.vandebruinhorst@utsouthwestern.edu

Principal Investigator
Christiana Hall

Summary

Participants will be recruited from those patients, who enter PHHS Emergency Department, with symptoms of intracerebral hemorrhage (ICH) less than five hours form symptom onset.
An immediate CTA is now standard of care for all patients who present to PHHS emergency department with symptoms of a stroke, before going to the ED room. Exceptions to this stat rule are patients with known renal disease or Diabetes mellitus, who will first receive a creatinine level and results prior to CTA. Patients transferred from an outside hospital will also have their CTA brain repeated once they arrive at PHHS. The CTA will be reviewed by the local study investigator to determine the presence or absence of the CTA spot sign (seen during contrast injection as a puff of smoke on the CTA). Patient flow will be determined by the local investigator[Right Quote]s interpretation of the CTA. The first arm will be a multicenter, randomized, double-blind, placebo-controlled trial comparing a one time rFVIIa 80 μg/kg IV bolus to placebo for treatment of patients with acute ICH and a spot sign on CTA. The second arm will be a multicenter, prospective observational study of hematoma growth among patients without a spot sign on CTA. Comparisons will be made between 1) patients with a spot sign randomized to placebo and patients without a spot sign, in order to determine the value of the spot sign for predicting hematoma growth and 2) patients who have a spot sign and are randomized to rFVIIa or placebo in order to determine the effect of study drug upon hematoma growth. Patients without a spot sign will receive standard medical care.
The primary para-clinical outcome of the STOP-IT study will be the rate of hematoma growth among spot-positive subjects at 24 hours, comparing subjects treated with rFVIIa to those treated with placebo. Hematoma growth will be defined as a and amp;gt; 33% or and amp;gt; 6 cc increase in volume.
Secondary outcomes measures will be the rate of total hemorrhage volume growth (hematoma plus
IVH) among spot-positive subjects and clinical outcomes among patients treated with rFVIIa vs.
those treated with placebo. Analysis will be performed for mortality at 90 days and good (modified Rankin Score 0-4) versus poor (modified Rankin Score 5-6) functional outcome.

Participant Eligibility

Inclusion Criteria
1. 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)
2. Age ≥ 18 through 80 years (candidates must have had their 18th birthday, but not had
their 81st birthday)
3. For spot positive patients, dosing of study drug within 90 minutes of enrolling CT scan