Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00029315
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2002-01-10
Brief Title:
Intraventricular Rt-PA in Patients With Intraventricular Hemorrhage
Sponsor:
Johns Hopkins University
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
Intraventricular Rt-PA Pharmacokinetic and Pharmacodynamic Study
Status:
COMPLETED
Status Verified Date:
2001-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study to evaluate how recombinant tissue plasminogen activator rt-PA is utilized in patients with intraventricular hemorrhage IVH rt-PA is a drug that has been shown to dissolve blood and may allow intraventricular catheters to be more effective for a longer period of time
Detailed Description:
IVH occurs in about 40 percent of intracerebral hemorrhage cases and 15 percent of aneurysmal subarachnoid hemorrhage cases Evidence supports a strong contribution of IVH to morbidity and mortality after cerebral hemorrhage External ventricular drainage EVD is required clinical management however EVD via intraventricular catheter alone fails to prevent much of the morbidity and mortality of IVH This study seeks to demonstrate the safety and efficacy of intraventricular thrombolysis using rt-PA as a method of removing this blood and altering morbidity and mortality Patients will receive intraventricular injections of rt-PA or placebo every 12 hours They will be followed prospectively with daily head CT scans during the acute-treatment phase and again between Days 28 and 32
Completion date provided represents the completion date of the grant per OOPD records
Completion date provided represents the completion date of the grant per OOPD records
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FD-R-002018-01 | None | None | None |