Clinical Trial on Treatment of Intraventricular Hemorrhage
Condition: Intraventricular Hemorrhage
MeSH terms: Cerebral Hemorrhage; Hemorrhage
Intervention: tissue plasminogen activator, rt-PA (thrombolytic) (Cathflo)
Intervention description: 0.3 mg and 1.0 mg of rt-PA (Cathflo) were administered every 12 hours (dose finding) and every 8 hours (dose frequency) via the intraventricular catheter to treat intraventricular hemorrhage.
Intervention MeSH terms: Plasminogen; Tissue Plasminogen Activator; Fibrinolytic Agents
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Intraventricular hemorrhage (IVH); rt-PA

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.
    

Eligibility 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.