Phase 2
N=110
Minimally Invasive Surgery and rtPA for Intracerebral Hemorrhage Evacuation
Intracerebral Hemorrhage
Bottom Line
View on ClinicalTrials.gov: NCT00224770 ↗Enrolled (actual)
110
Serious AEs
51.8%
Results posted
Jun 2015
Primary outcome: Primary: Safety Outcome Number 1: Rate of Mortality — 9.5; 14.8; 7.1 percentage of participants — p=0.324
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MIS+Cathflo Activase (drug) (Drug); Intraoperative stereotactic CT-Guided Endoscopic Surgery (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Daniel Hanley
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Outcome Number 1: Rate of Mortality |
9.5; 14.8; 7.1 | 0.324 |
| PRIMARY Safety Outcome Number 2: Rate of Procedure-related Mortality |
0; 5.6; 0 | 0.174 |
| PRIMARY Safety Outcome Number 3: Rate of Cerebritis, Meningitis, Bacterial Ventriculitis |
2.4; 0; 0 | 0.437 |
| PRIMARY Safety Outcome Number 4: Rate of Symptomatic Rebleeding |
2.4; 5.6; 0 | 0.409 |
| PRIMARY Efficacy Outcome Number 1: Dichotomized Modified Rankin Scale (mRS) at Day 180 |
23.7; 34.6; 42.9 | 0.189 |
| SECONDARY Ordinal Modified Rankin Scale (mRS) at Day 180 |
4; 4; 4 | 0.468 |
| SECONDARY Ordinal Modified Rankin Scale (mRS) at Day 365 |
4.5; 4; 3.5 | 0.395 |
| SECONDARY Clot Size Reduction by End of Treatment |
3.9; 64.3; 69.5 | <0.0001 sig |
| SECONDARY Post-operative Clot Size Reduction |
56.7; -6.4 | <0.0001 sig |
Summary
The purpose of this trial is to determine the safety of using a combination of minimally invasive surgery and clot lysis with rt-PA to remove intracerebral hemorrhage (ICH). The ICES arm of the trial will determine the safety of endoscopic surgery to remove ICH. All MISTIE intention to treat subjects represent the hypothesized test group. The ICES cohort is to be analyzed separately.
Eligibility Criteria
Inclusion Criteria
- Age 18-80
- GCS or equal to 6
- Spontaneous supratentorial ICH > or equal to 20cc
- Symptoms less than 12 hours prior to diagnostic CT scan (an unknown time of symptom onset is exclusionary)
- Intention to initiate surgery within 48 hours after diagnostic CT
- 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) (Does not apply to ICES Tier)
- 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)
- SBP 1.4, 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
- Clotting disorders
- Any concurrent serious illness that would interfere with the safety assessments including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease
- Patients with a mechanical valve
- Patients with unstable mass or evolving intracranial compartment syndrome
- Ruptured aneurysm, AVM, vascular anomaly
- Greater than 80 years (higher incidence of amyloid)
- Under 18 years of ag e (high incidence of occult vascular malformation)
- Pregnant (positive pregnancy test) or lactating females (likelihood of altered coagulation function associated with the high estrogen/progesterone state)
- Irreversibly impaired brainstem function (bilateral fixed, dilated pupils and extensor motor posturing), GCS less than or equal to 4
- Historical Rankin score greater than or equal to 2
- Intraventricular hemorrhage requiring external ventricular drainage
- Internal bleeding, involving retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts (Does not apply to ICES Tier)
- Superficial or surface bleeding, observed mainly at vascular puncture and access sites (e.g., venous cutdowns, arterial punctures) or site of recent surgical intervention (Does not apply to ICES Tier)
- Known risk for embolization, including history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis, and subacute bacterial endocarditis (Does not apply to ICES Tier)
- In the investigator's opinion, the patient is unstable and would benefit from a specific intervention rather than supportive care plus or minus MIS+rtPA
- Prior enrollment in the study
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- Participation in another simultaneous trial of ICH treatment.
Data sourced from ClinicalTrials.gov (NCT00224770). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.