Spontaneous supratentorial intracerebral haemorrhage MedDRA version: 18.0 Level: PT Classification code 10062025 Term: Intracerebral haematoma evacuation System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Sponsors
The John Hopkins University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Spontaneous supratentorial ICH = 30 mL measured by the site utilizing ABC/2 method using radiographic imaging (CT, CTA, etc.), with a GCS = 14 or a NIHSS = 6. 2) Stability CT scan done at least 6 hours after diagnostic CT showing clot stability (growth =65 years) yes F.1.3.1 Number of subjects for this age range 250
Exclusion criteria
Exclusion criteria: 1) Infratentorial hemorrhage. 2) Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoya disease, hemorrhagic conversion of an ischemic infarct, recurrence of a recent ( 1.4. 8) Any irreversible coagulopathy or known clotting disorder. 9) Inability to sustain INR = 1.4 using short- and long-acting procoagulants (such as but not limited to NovoSeven, FFP, and/or vitamin K). 10) Subjects requiring long-term anti-coagulation are excluded. Reversal of anticoagulation is permitted for medically stable patients who can realistically tolerate the short term risk of reversal. Patient must not require Coumadin (anticoagulation) during the first 30 days, and normalized coagulation parameters must be demonstrated, monitored closely and maintained during the period of brain instrumentation. 11) Use of Dabigatran, Apixaban, and/or Rivaroxaban (or a similar medication from the similar medication class) prior to symptom onset. 12) Internal bleeding involving retroperitoneal, gastrointestinal, or genitourinary site or respiratory tract bleeding. 13) Superficial or surface bleeding, observed mainly at vascular puncture and access sites (e.g., venous cutdowns, arterial punctures, etc.) or site of recent surgical intervention. 14) Positive urine or serum pregnancy test in pre-menopausal female subjects without a documented history of surgical sterilization. 15) Allergy/sensitivity to rt-PA. 16) Prior enrollment in the study. 17) Participation in a concurrent interventional medical investigation or clinical trial. Patients in observational, natural history, and/or epidemiological studies not involving an intervention are eligible. 18) Not expected to survive to the day 365 visit due to co-morbidities, or are DNR/DNI status prior to randomization. 19) Any concurrent serious illness that would interfere with the outcome assessments including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease. 20) Patients with a mechanical heart valve. Presence of bio-prosthetic valve(s) is permitted. 21) Known risk for embolization, including history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis, or subacute bacterial endocarditis. Atrial fibrillation without mitral stenosis is permitted. 22) Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show whether minimally invasive surgery (MIS) plus recombinant tissue plasminogen activator (rt-PA) for three days improves outcome at six months as compared to standard medical treatment in patients with spontaneous bleeding in the brain (with no underlying cause)(ICH). It will also show whether early use of MIS+rt-PA for three days is safe for the treatment of ICH relative to rates of mortality, rebleeding, and infection in the medically treated subject at 30 days. ;Secondary Objective: To show whether the reduction in the size of the blood clot in the brain acheived by using MIS+rt-PA is related to improved functional outcome, as compared to medically treated subjects.;Primary end point(s): Overall better functional outcome at 180 days, as defined by the modified Rankin Scale (mRS) using dichotomized adjudicated mRS 0-3 vs. 4-6 at 180 days post-stroke;Timepoint(s) of evaluation of this end point: 180 days post-stroke | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 30, 180 and 365 days.; Secondary end point(s): Dichotomized adjudicated mRS at 365 days post-stroke 0-3 vs. 4-6 and 0-2 vs. 3-6 Ordinal adjudicated mRS (0 – 6) at 180 days post-stroke Mortality and Safety Events at 30 days post-randomization including procedurerelated mortality, symptomatic bleeding rate, and infection rate Mortality at 180 days post stroke Functional Status: NIHSS, Barthel, GOS, GOSE, MMSE at 180 days Type and intensity of ICU management: ICU days, hospital days, patient disposition at 180 days and 365 days Quality of life: SIS, EQ-5D, PBSI,Personal Health Utility Assessment Cost CES-D at 180 days | — |
Countries
Australia, Canada, China, Germany, Hungary, Israel, Spain, United Kingdom, United States
Contacts
Public ContactDr Barbara Gregson
Newcastle University
Outcome results
None listed