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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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The overall purpose of this study is to look at the safety and effectiveness of administering Tenecteplase (TNK) into the brain bleed (hematoma) instead of another clot-dissolving drug known as recombinant tissue plasminogen activator (rtPA), which is the current standard practice. Clot dissolving (Fibrinolytic) drugs work to break down blood clots and have been found to improve health outcomes when applied directly into the hematoma within the brain. Patients who take part in this study will undergo the same surgical procedure that would normally be performed to treat them, but with the exception of TNK not rtPA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TNK | Experimental | Participants would be given TNK through a brain catheter to dissolve an intracerebral blood clot after a hemorrhage. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TNK | Drug | TNK will be delivered into the site of the intracerebral hemorrhage via a brain catheter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Assessment | To assess the safety of 0.25 mg TNKase (single dose) administered directly into the hematoma via a soft brain catheter in patients with ICH. | From treatment until follow-up date (+/- 30 days) |
| Adverse Event Evaluation | To evaluate the incidence and severity of adverse events, such as rehemorrhage, infection, mortality at 30 days following the administration of TNKase. | From treatment until follow-up date (+/- 30 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Radiological Assessment of the Hematoma Resolution | Using radiological imaging, we will assess the resolution of the hematoma from the brain with the end of treatment volume goal as 15 ml and compare these findings to baseline imaging obtained prior to TNKase administration | From treatment until follow-up date (+/- 30 days) |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christine N Yohn, Ph D | Contact | 908-328-4210 | cy253@rutgers.edu |
| Name | Affiliation | Role |
|---|---|---|
| Gaurav Gupta, MD | Rutgers University, RWJ Medical School | Principal Investigator |
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| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| D020300 | Intracranial Hemorrhages |
| D000083302 | Hemorrhagic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020521 | Stroke |