Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06429553
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-05-05
Brief Title:
Minimally Invasive Intracranial Hematoma Aspiration for Spontaneous Intracerebral Hemorrhage
Sponsor:
Anhui Provincial Hospital
Organization:
Anhui Provincial Hospital
Study Overview
Official Title:
A Multicenter Randomized Controlled Clinical Study of Minimally Invasive Intracranial Hematoma Aspiration and Drainage Combined With Urokinase Injection and Drug Therapy for Spontaneous Intracerebral Hemorrhage
Status:
RECRUITING
Status Verified Date:
2024-05
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:
To observe the effect of minimally invasive intracranial hematoma aspiration and drainage combined with urokinase injection and drug therapy on prognosis of spontaneous cerebral hemorrhage
Detailed Description:
Intracerebral hemorrhage ICH refers to the spontaneous rupture of large and small arteries veins and capillaries in the brain caused by various reasons under non-traumatic conditions Hypertension is the most common predisposing factor for intracerebral hematoma and the risk increases with age The challenge in surgical hematoma evacuation lies in the potential for surgical complications to negate the benefits of hematoma removal Surgical treatment is generally considered only when the supratentorial hematoma causes a life-threatening space-occupying effect Therefore the size of the intracerebral hematoma is a key factor in determining whether surgery can bring benefits to patients Specifically intracerebral hematomas with a volume less than 30 ml are considered small and medium-sized
Previously drug-based conservative treatment was often the first choice for small and medium-sized intracerebral hematomas However with the accumulation of clinical data it has been found that while these patients have low blood loss and mortality their neurological function impairment is significant and the recovery of neurological function under conservative treatment is often suboptimal Therefore some scholars have suggested the use of adjunctive surgical options for small and medium-sized intracerebral hematomas such as small craniotomy craniotomy endoscopic surgery fibrinolytic therapy combined with hematoma aspiration and CT-guided stereotactic aspiration ie minimally invasive surgery
Previously drug-based conservative treatment was often the first choice for small and medium-sized intracerebral hematomas However with the accumulation of clinical data it has been found that while these patients have low blood loss and mortality their neurological function impairment is significant and the recovery of neurological function under conservative treatment is often suboptimal Therefore some scholars have suggested the use of adjunctive surgical options for small and medium-sized intracerebral hematomas such as small craniotomy craniotomy endoscopic surgery fibrinolytic therapy combined with hematoma aspiration and CT-guided stereotactic aspiration ie minimally invasive surgery
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?:
None
Is an FDA AA801 Violation?:
None