intracerebral hemorrhage MedDRA version: 13.1 Level: PT Classification code 10062025 Term: Intracerebral haematoma evacuation System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Cathflo Activase (Alteplase)
Product Name: Cathflo Activase (Alteplase)
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: ALTEPLASE
CAS Number: 105857236
Concentr
Sponsors
Newcastle upon Tyne Hospitals NHS Trust
Johns Hopkins University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18-80 2. GCS 6; 3. Spontaneous supratentorial ICH > 20cc; 4. Symptoms less than 12 hours prior to diagnostic CT scan (an unknown time of symptom onset is exclusionary); 5. Intention to initiate surgery within 48 hours after diagnostic CT; 6. First dose can be given within 54 hours after diagnostic CT (delays for post surgical stabilization of catheter bleeding or because of unanticipated surgical delay are acceptable with approved waiver from the coordinating center); 7. Six-hour clot size equal to the most previous clot size + 5 cc (as determined by an additional CT scan at least 6 hours after the initial stability scan (A*B*C)/2 method); 8. SBP =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Infratentorial hemorrhage (any involvement of the midbrain or lower brainstem as demonstrated by radiograph or complete third nerve palsy); 2. Patients with platelet count 1.3, or an elevated PT or APTT (reversal of coumadin is permitted but the patient must not require coumadin during the acute hospitalization). Irreversible coagulopathy either due to medical condition or prior to randomization (patient must have a sustained INR = 1.3 using short- and long-acting procoagulants [such as but not limited to NovoSeven, FFP, and/or vitamin K]); 3. Clotting disorders; 4. Any concurrent serious illness that would interfere with the safety assessments including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease; 5. Patients with a mechanical valve; 6. Patients with unstable mass or evolving intracranial compartment syndrome; 7. Ruptured aneurysm, AVM, vascular anomaly, Moyamoya disease; 8. Irreversibly impaired brainstem function (bilateral fixed, dilated pupils and extensor motor posturing), GCS less than or equal to 4; 9. Intraventricular hemorrhage requiring external ventricular drainage; 10. Internal bleeding, involving retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts; 11. Superficial or surface bleeding, observed mainly at vascular puncture and access sites (e.g., venous cutdowns, arterial punctures) or site of recent surgical intervention; 12. Known risk for embolization, including history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis, or subacute bacterial endocarditis; 13. In the investigator’s opinion, the patient is unstable and would benefit from a specific intervention rather than supportive care plus or minus endoscopic or MIS+rtPA removal of the ICH; 14. Prior enrollment in the study; 15. Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated; 16. Participation in another simultaneous trial of ICH treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the safety of minimally invasive surgery plus aspiration followed by the administration of a low dose of recombinant tissue plasminogen activator (rt-PA; Activase, Genentech, Inc., San Francisco, CA) to intracerebral hemorrhage patients (ICH) via a catheter inserted directly into the clot and to assess its ability to remove blood clot from the brain tissue;Secondary Objective: To test if the intervention facilitates more rapid and complete recovery of function and decreased mortality compared to conventional medical management without subjecting the patient to craniotomy.;Primary end point(s): 1.) 30-day mortality 2.) procedure related mortality 3.) incidence of cerebritis, meningitis 4.) rate of rebleeding | — |
Countries
Germany, United Kingdom
Outcome results
None listed