Clinical Trial on Treatment of Intraventricular Hemorrhage

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The specific objective of this trial is to determine the lowest dose and dose frequency possible with the best pharmacokinetic and safety profile and it's ability to remove a blood clot from the ventricular system.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborators: FDA Office of Orphan Products Development; Genentech, Inc.
• Treatments: Fibrinolytic Agents; Plasminogen; Tissue Plasminogen Activator

Criteria

Inclusion Criteria:

1. Age 18-75

2. IVC placed as standard of care using less than or equal to 2 complete passes.

3. Spontaneous ICH less than or equal to 30 cc.

4. Able to receive first dose within 48 hours of CT scan diagnosing IVH (providing the time of symptom onset to diagnostic CT does not exceed 12 hours).

5. Clot size measured on CT scan done 6 hours after IVC placement must be equal to the presentation clot size plus or minus 5 cc (as determined by the AxBxC)/2 method).

6. ON stability CT scan either the 3rd or 4th ventricles are occluded with blood (no evidence of CSF flow on CT).

7. SBP < 200 mmHg sustained for 6 hours.

8. Historical Rankin of 0 or 1.

Exclusion Criteria:

1. Suspected or untreated aneurysm or AVM (unless ruled out by angiogram or MRA/MRI).

2. Clotting disorders.

3. Patients with platelet count < 100,000, INR > 1.7, PT > 15s, or an elevated APTT.

4. Pregnancy (positive pregnancy test).

5. Infratentorial hemorrhage (i.e., parenchymal/posterior fossa hematoma; all cerebellar hematomas excluded).

6. SAH (An angiogram should be obtained when the diagnostic CT scan demonstrates subarachnoid hemorrhage or any hematoma location or appearance not strongly associated with hypertension. If the angiogram does not demonstrate a bleeding source that accounts for the hemorrhage, the patient is eligible for the study).

7. ICH enlargement during the 6-hour stabilization period (6 hour after IVC placement).

8. Internal bleeding, involving retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts.

9. Superficial or surface bleeding, observed mainly at vascular puncture and access sites (e.g., venous cutdowns, arterial punctures) or site of recent surgical intervention.

10. Known risk for embolization, including history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis, and subacute bacterial endocarditis.

11. Prior enrollment in the study.

12. Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.

13. Participation in another simultaneous medical investigation or trial.