Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00283400
Status:
TERMINATED
Last Update Posted:
2015-04-01
First Post:
2006-01-26
Brief Title:
Treatment of Subarachnoid Hemorrhage With Human Albumin
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Treatment of Subarachnoid Hemorrhage With Human Albumin
Status:
TERMINATED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study met safety endpoints
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 evaluate the tolerability and safety of 25 percent human albumin therapy in patients with subarachnoid hemorrhage
Detailed Description:
An estimated 37500 people in the United States have subarachnoid hemorrhage SAH every year SAH is usually secondary to a brain aneurysm that has burst In SAH the bleeding accumulates around the lining of the brain SAH is associated with a 51percent mortality rate and one third of survivors are left functionally dependent Cerebral vasospasm which is a delayed narrowing of the cerebral arteries following SAH has been identified as the most important reason for neurological deterioration and bad outcome in cases of SAH Cerebral vasospasm may be caused by multiple mechanisms
Treatment with a neuroprotective agent such as human albumin HA may be beneficial for prevention of cerebral vasospasm and improved clinical outcome in patients with SAH HA is a major protein found in blood and is responsible for maintaining fluid balance in the vascular system blood vessels The purpose of this study was to determine the safety and tolerability of 25 percent HA therapy in patients with SAH This open-label dose-escalation study will provide necessary information for a future definitive phase III clinical trial on the efficacy of treatment with HA in patients with SAH
The study was designed to enroll 80 patients at 5 centers in the US Patients with eligible SAH first underwent surgical or endovascular repair which was considered standard care Endovascular repair was a repair of the aneurysm from the inside of the blood vessel
Following neurosurgical or endovascular treatment participants were given a daily infusion of HA for 7 days The HA dose was allocated as follows the first tier 20 patients would receive 0625 grams g of HA per kilogram kg of body weight patients in the second tier would receive 125g of HA per kg patients in the third tier would receive 1875g of HA per kg and patients in the fourth tier would receive 25g of HA per kg Safety and tolerability was evaluated by the Data and Safety Monitoring Board DSMB after each tier was completed and before the study advanced to the next dose tier A specific safety threshold for congestive heart failure and other adverse events was defined based on data from previous studies
In the follow-up phase patients participated in study-related evaluations of their health at 15 days and three months Duration of the study for participants was 90 days
Treatment with a neuroprotective agent such as human albumin HA may be beneficial for prevention of cerebral vasospasm and improved clinical outcome in patients with SAH HA is a major protein found in blood and is responsible for maintaining fluid balance in the vascular system blood vessels The purpose of this study was to determine the safety and tolerability of 25 percent HA therapy in patients with SAH This open-label dose-escalation study will provide necessary information for a future definitive phase III clinical trial on the efficacy of treatment with HA in patients with SAH
The study was designed to enroll 80 patients at 5 centers in the US Patients with eligible SAH first underwent surgical or endovascular repair which was considered standard care Endovascular repair was a repair of the aneurysm from the inside of the blood vessel
Following neurosurgical or endovascular treatment participants were given a daily infusion of HA for 7 days The HA dose was allocated as follows the first tier 20 patients would receive 0625 grams g of HA per kilogram kg of body weight patients in the second tier would receive 125g of HA per kg patients in the third tier would receive 1875g of HA per kg and patients in the fourth tier would receive 25g of HA per kg Safety and tolerability was evaluated by the Data and Safety Monitoring Board DSMB after each tier was completed and before the study advanced to the next dose tier A specific safety threshold for congestive heart failure and other adverse events was defined based on data from previous studies
In the follow-up phase patients participated in study-related evaluations of their health at 15 days and three months Duration of the study for participants was 90 days
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 |
|---|---|---|---|
| R01NS049135 | NIH | None | httpsreporternihgovquickSearchR01NS049135 |