Stanford School of Medicine
Neurosurgery–

Minimally Invasive Surgery Plus rt-PA for ICH Evacuation (MISTIE)

Contact Information

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

Primary Contact:

Stephanie Kemp (650) 723-4481

Brief

The purpose of this trial is to evaluate the safety of rt-PA, the study drug, when used in combination with minimal surgery (insertion of a catheter into the brain) in the removal of a blood clot from the brain. We propose to test if this intervention facilitates more rapid and complete recovery of function and decreased mortality in patients with an intracerebral hemorrhage compared to conventional medical management without subjecting the patient to craniotomy. The specific objective of this trial is to test the safety of this intervention and assess its ability to remove blood clot from brain tissue.

Recruiting Status:

Recruiting

Stanford Recruiting Status:

Recruiting

Condition(s):

Intervention(s):

  • Drug: Recombinant Tissue Plasminogen Activator (rtPA) (Cathflo Activase)

Phase:

N/A

Eligibility

Ages Eligible for Study:

18 years to 80 years

Genders Eligible for Study:

Male and Female

Health of Volunteers:

People with the conditions listed in this trial can participate as controls.

Key Inclusion Criteria:

1. Age 18-80
2. GCS < 14 or a NIHSS > 6;
3. Spontaneous supratentorial ICH > 25cc;
4. Symptoms less than 12 hours prior to diagnostic CT scan (an unknown time of symptom onset is exclusionary);
5. First dose can be given within 36 hours of symptom onset (plus a 2-hour feasibility window with approval from the coordinating center, reserved for only those situations where the patient is eligible, consented, stable but personnel scheduling prohibits giving the first dose within the 36-hour window);
6. 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);
7. SBP < 200 mmHg sustained for 6 hours;
8. Historical Rankin score of 0 or 1;
9. Negative pregnancy test.

Key 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 < 100,000, INR > 1.7, PT > 15s, or an elevated 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;
3. Clotting disorders;
4. Any concurrent serious illness that would interfere with the safety assessments including hepatic, renal, gastroenteroligic, 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;
8. Greater than 80 years (higher incidence of amyloid);
9. Under 18 years of age (high incidence of occult vascular malformation);
10. Pregnant (positive pregnancy test) or lactating females (likelihood of altered coagulation function associated with the high estrogen/progesterone state);
11. Irreversibly impaired brainstem function (bilateral fixed, dilated pupils and extensor motor posturing), GCS less than or equal to 4;
12. Historical Rankin score greater than or equal to 2;
13. Intraventricular hemorrhage requiring external ventricular drainage;
14. Internal bleeding, involving retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts;
15. Superficial or surface bleeding, observed mainly at vascular puncture and access sites (e.g., venous cutdowns, arterial punctures) or site of recent surgical intervention;
16. Known risk for emobolization, including history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis, and subacute bacterial endocarditis;
17. 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;
18. Prior enrollment in the study;
19. Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated;
20. Participation in another simultaneous trial of ICH treatment.

Additional Study Details

Official Title:

Minimally Invasive Surgery Plus rt-PA for ICH Evacuation (MISTIE)

Anticipated start date:

1/28/2008

Lead Sponsor:

NIH

Collaborator(s):

  • Johns Hopkins University

Investigator(s):

Study Type:

Interventional

Purpose:

Treatment

Allocation:

Randomized

Masking:

Open

Control:

none

Assignment:

Single Group

Endpoints:

Safety/Efficacy

Primary Outcomes:

  • 30 day mortality
  • procedure related mortality
  • Incidence of cerebritis, meningitis
  • rate of rebleeding

Secondary Outcomes:

  • Rate of clot size reduction at Days 4-5 determined by CT scans
  • 90 & 180 day GOS, Rankin, Stroke Impact Scale

Total Number to be Enrolled:

100

Total Number to be Enrolled at Stanford:

10

More Information

Trial Unique Id: SU-11152007-890

Locations & Contacts

Stanford Locations & Contacts:

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

Primary Contact:

Stephanie Kemp (650) 723-4481

Non-Stanford Locations:

The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.

This listing was last updated:

9/11/2009

PLEASE NOTE:

Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.

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