1. Suspected (unless ruled out by angiogram or MRA/MRI) or untreated ruptured cerebral aneurysm, ruptured intracranial AVM, or tumor. Treatment of an existing aneurysm or AVM must have occurred at least 3 months before the current onset.
Temporary criterion: This is especially important in primary IVH, when no ICH source is found. CT angiogram, angiogram, MRA/MRI, or general diagnostic study (prior to confirming patient eligibility in the protocol) is standard of care to rule out underlying etiology. If the CT angiogram, angiogram or MRA/MRI is negative, the patient is eligible. The PI must document rationale if imaging is not done.
2. Presence of a choroid plexus vascular malformation or Moyamoya disease.
3. Clotting disorders. Subjects requiring long-term anti-coagulation are excluded.
Temporary criterion: Reversing anticoagulation will be permitted where long-term anticoagulation is not required.
4. Use of Dabigatran prior to symptom onset.
5. Platelet count < 100,000, INR > 1.4.
Temporary criterion: Low platelet counts etc. on admission can normalize within 24 hours as can an INR normalize to < 1.4.
6. Pregnancy (positive serum or urine pregnancy test).
7. Infratentorial hemorrhage
8. Thalamic bleeds with apparent midbrain extension with third nerve palsy or dilated and non-
reactive pupils. Other (supranuclear) gaze abnormalities are not an exclusion. Note: Patients
with a posterior fossa ICH or cerebellar hematomas are ineligible.
9. SAH at clinical presentation (an angiogram (angiogram, CTA, MRA/MRI) must be obtained
when the diagnostic CT scan shows SAH or any hematoma location or appearance not strongly associated with hypertension. If the angiogram or other imaging does not detect a bleeding source to account for the hemorrhage, the patient is eligible for the study.) Subsequent appearance of cortical SAH secondary to clot lysis is not a dosing endpoint.
Temporary criterion: An angiogram must be obtained when the diagnostic CT scan demonstrates subarachnoid hemorrhage or any hematoma location suggestive of aneurysm or appearing not strongly associated with hypertension. If the angiogram/imaging does not demonstrate a bleeding source that accounts for the hemorrhage, the patient is eligible for the study.
10. ICH/IVH enlargement that cannot be stabilized in the treatment time window.
Temporary criterion: ICH enlargement during the 6-hour stabilization period (6 hours after IVC placement): It is permitted to screen up to 72 hours after diagnostic scan. If the ICH clot size stabilizes (i.e., enlarges no more than 5 cc) and does not exceed 35 cc (an ICH clot size of 35 cc allows for stabilization of a 5cc expansion for those patients at the upper limit of the ICH clot size limit), the patient is eligible.
11. Ongoing internal bleeding, involving retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts. (Patient with prior bleeding that is clinically stable for 12 h or more without any coagulopathy or bleeding disorder is eligible).
12. Multi-focal, superficial bleeding, observed at multiple vascular puncture and access sites (e.g., venous cutdowns, arterial punctures) or site of recent surgical intervention.
13. Prior enrollment in the study.
14. Any other condition that the investigator believes would pose a significant hazard to the
subject if the investigational therapy were initiated. Subjects who are not expected to survive to the day 180 visit due to co-morbidities and/or are DNR/DNI status prior to randomization are excluded.
Temporary criterion: Although these situations are often irreversible, under
other conditions, change can occur over 24 hours.
15. Planned or simultaneous participation (between screening and Day-30) in another
interventional medical investigation or clinical trial. Patients involved in observational,
natural history, and/or epidemiological studies not involving an intervention are eligible.
16. No subject or legal representative to give written informed consent.