NCT06429553

Minimally Invasive Intracranial Hematoma Aspiration for Spontaneous Intracerebral Hemorrhage

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Anhui Provincial Hospital · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 (i.e., minimally invasive surgery).

Conditions

• Spontaneous Cerebral Hemorrhage

Interventions

Type	Name	Description
PROCEDURE	Minimally invasive hematoma aspiration drainage combined with urokinase injection	Minimally invasive hematoma aspiration drainage combined with urokinase injection

Timeline

• Start date: 2023-07-01
• Primary completion: 2024-06-30
• Completion: 2025-06-30
• First posted: 2024-05-28
• Last updated: 2024-05-28

Locations

1 site across 1 country: China