Clinical Trial on Treatment of Intraventricular Hemorrhage "CLEAR IVH"

Completed

Phase 2 Results

Update History

13 Dec '17
The description was updated.
New
The purpose of this trial is to determine the efficacy and pharmacokinetics of intraventricular injections of multiple low doses of rt-PA. Sixteen subjects were already randomized to receive intraventricular injections of with 0.3 mg or 1.0 mg of rt-PA every 12 hours for up to 8 doses. Results of this stage (n=16) were then analyzed and the most effective dose of 1.0 mg was chosen to be used in the second stage (n=36) to determine the optimal frequency of dosing. We propose to test if this intervention facilitates more rapid clot resolution, complete recovery function and decreased mortality from this condition.
Old
The purpose of this trial is to determine the efficacy and pharmacokinetics of intraventricular injections of multiple low doses of rt-PA. Sixteen subjects were already randomized to receive intraventricular injections of with 0.3 mg or 1.0 mg of rt-PA every 12 hours for up to 8 doses. Results of this stage (n=16) were then analyzed and the most effective dose of 1.0 mg was chosen to be used in the second stage (n=36) to determine the optimal frequency of dosing. We propose to test if this intervention facilitates more rapid clot resolution, complete recovery function and decreased mortality from this condition.
The gender criteria for eligibility was updated to "All."
The eligibility criteria were updated.
New
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.
Old
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.
19 Jul '12
Trial name was updated.
New
Clinical Trial on Treatment of Intraventricular Hemorrhage
The Summary of Purpose was updated.
New
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.
Old
The specific objective of this trial is to determine the lowest dose possible with the best pharmacokinetic and safety profile and it's ability to remove a blood clot from the ventricular system.
A location was updated in Baltimore.
New
The overall status was removed for Johns Hopkins University.
A location was updated in Baltimore.
New
The overall status was removed for University of Maryland Medical Systems.
A location was updated in Detroit.
New
The overall status was removed for Wayne State University.
A location was updated in New York.
New
The overall status was removed for Mt. Sinai Medical Center.
A location was updated in Cincinnati.
New
The overall status was removed for University of Cincinnati.
A location was updated in Charleston.
New
The overall status was removed for Medical University of South Carolina.
A location was updated in Richmond.
New
The overall status was removed for Virginia Commonwealth University.