Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06284642
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-02-01
Brief Title:
Early Lumbar Drainage Combined With Intrathecal Urokinase Injection for Treatment of Severe Aneurysmal SAH LD-ITUK
Sponsor:
Second Affiliated Hospital of Nanchang University
Organization:
Second Affiliated Hospital of Nanchang University
Study Overview
Official Title:
Effectiveness and Safety of Early Lumbar Drainage Combined With Intrathecal Urokinase Injection in the Treatment of Severe Aneurysmal Subarachnoid Hemorrhage LD-ITUK a Multicentral Randomized Control Trial
Status:
RECRUITING
Status Verified Date:
2023-12
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 LD-ITUK is a multicenter prospective randomized double-blind blind endpoint placebo-control design trial All eligible patients with the diagnosis of severe aSAH will be randomly assigned to the treatment group or the placebo group Patients in the treatment group will receive standard treatment with the addition of lumbar drainage combined with intrathecal urokinase injection started within 24 hours after aneurysm treatment with 30000 IU urokinase once a day for 3 consecutive days Patients in the control group will receive standard treatment with the addition of lumbar drainage combined with intrathecal placebo 09NaCl injection The primary outcome measure is favorable functional outcome defined as a score of 0 to 2 on the modified Rankin Scale mRS at 6 months after aneurysmal SAH Primary outcome will be determined by a member of the Independent Committee on Terminal events
Detailed Description:
Aneurysmal subarachnoid hemorrhages aSAH represent about 8 of all strokes and 98 per 100000 per year in China which is higher than the overall annual incidence rate worldwide The cumulative death rate after-onset represent about 246 in China only about 30 survivors will be able to have a good neurological prognosis the majority of the remaining survivors suffer from long-term disability or cognitive impairment However these condition may be even worse in patients with severe aSAH
Studies suggest that early clearance of subarachnoid clot may be associated with a good neurological prognosis Indeed subarachnoid clot aggravate the phenomena of cerebral vasospasm and delayed cerebral ischemia in the delayed phase and promote cell injure within the hypoperfusion zone of the brain in the longer term Thus early removal of subarachnoid clot may have a favorable effect on neurological prognosis Current aSAH recommendations and guidelines advocate the use of lumbar drainage only in case of acute hydrocephalus The EARLYDRAIN trial suggests that lumber cerebrospinal fluid drainage can early remove subarachnoid clot compare to the standard neurocritical treatment and improve the prognosis after aSAH However the ratio of unfavorable prognosis in severe aSAH is still high
Intrathecal urokinase injection has been proved to effeciently remove the subarachnoid clot however no randomized control trials have been conducted to evaluate the improvement of lumbar drainage combined with intrathecal urokinase injection in the favorable functional outcome defined as a score of 0 to 2 on the modified Rankin Scale mRS at 6 months after aneurysmal SAH
The LD-ITUK trial was designed to evaluate whether severe aSAH treated by standard treatment with the addition of lumbar drainage combined with intrathecal urokinase injection have a significantly higher percentage of favourable outcome after six months score 0-2 on the Modified Rankin Scale compared to the placebo treated by standard treatment with the addition of lumbar drainage combined with intrathecal placebo 09NaCl injection
Studies suggest that early clearance of subarachnoid clot may be associated with a good neurological prognosis Indeed subarachnoid clot aggravate the phenomena of cerebral vasospasm and delayed cerebral ischemia in the delayed phase and promote cell injure within the hypoperfusion zone of the brain in the longer term Thus early removal of subarachnoid clot may have a favorable effect on neurological prognosis Current aSAH recommendations and guidelines advocate the use of lumbar drainage only in case of acute hydrocephalus The EARLYDRAIN trial suggests that lumber cerebrospinal fluid drainage can early remove subarachnoid clot compare to the standard neurocritical treatment and improve the prognosis after aSAH However the ratio of unfavorable prognosis in severe aSAH is still high
Intrathecal urokinase injection has been proved to effeciently remove the subarachnoid clot however no randomized control trials have been conducted to evaluate the improvement of lumbar drainage combined with intrathecal urokinase injection in the favorable functional outcome defined as a score of 0 to 2 on the modified Rankin Scale mRS at 6 months after aneurysmal SAH
The LD-ITUK trial was designed to evaluate whether severe aSAH treated by standard treatment with the addition of lumbar drainage combined with intrathecal urokinase injection have a significantly higher percentage of favourable outcome after six months score 0-2 on the Modified Rankin Scale compared to the placebo treated by standard treatment with the addition of lumbar drainage combined with intrathecal placebo 09NaCl injection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None