Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00282893
Status:
COMPLETED
Last Update Posted:
2017-02-15
First Post:
2006-01-26
Brief Title:
Balloon Prophylaxis of Aneurysmal Vasospasm
Sponsor:
University of California Davis
Organization:
University of California Davis
Study Overview
Official Title:
Balloon Prophylaxis of Aneurysmal Vasospasm
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if early transluminal ballooning of the major cerebral arteries prevents severe vasospasm and improves neurological outcome in patients with Fisher Grade III aneurysmal subarachnoid hemorrhage
Detailed Description:
Aneurysmal subarachnoid hemorrhage SAH afflicts over 30000 patients a year in the United States Fifteen percent of those who survive the initial bleeding die or suffer disabilities because of delayed ischemic deficit stroke due to vasospasm Vasospasm is a condition in which the arteries in the brain constrict not allowing sufficient blood flow and oxygenation Research on the pharmacological prevention and treatment of vasospasm has resulted in only minimal improvement for this problem
Transluminal ballooning is a procedure that opens blood vessels allowing blood flow and oxygen to get to the brain more easily Researchers believe that this dilation of the blood vessels lasts for at least 7 days This procedure is used to treat severe vasospasm although it is not commonly used to prevent vasospasm The purpose of this trial is to find out if this procedure performed immediately after the aneurysm is secured prevents spasm in the brain and improves patient outcome
Eligible SAH patients whose aneurysm has been repaired by neurosurgical or endovascular procedure and who are enrolled in the study will be randomized to receive either the prophylactic transluminal ballooning procedure or to receive standard care which includes currently existing therapies for the treatment of vasospasm
Participants will be asked to return for follow-up examinations at 3 and 6 months to evaluate recovery using a standardized outcome scale
Transluminal ballooning is a procedure that opens blood vessels allowing blood flow and oxygen to get to the brain more easily Researchers believe that this dilation of the blood vessels lasts for at least 7 days This procedure is used to treat severe vasospasm although it is not commonly used to prevent vasospasm The purpose of this trial is to find out if this procedure performed immediately after the aneurysm is secured prevents spasm in the brain and improves patient outcome
Eligible SAH patients whose aneurysm has been repaired by neurosurgical or endovascular procedure and who are enrolled in the study will be randomized to receive either the prophylactic transluminal ballooning procedure or to receive standard care which includes currently existing therapies for the treatment of vasospasm
Participants will be asked to return for follow-up examinations at 3 and 6 months to evaluate recovery using a standardized outcome scale
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 |
|---|---|---|---|
| R01NS038484 | NIH | None | httpsreporternihgovquickSearchR01NS038484 |