Minimally invasive procedure for treating spontaneous brain 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

This study tests a new, less invasive way to treat brain bleeding in patients with small to medium-sized blood clots to see if it helps them recover better than standard treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Anhui Provincial Hospital (Government)
• Locations: 1 site (Hefei, Anhui)
• Trial ID: NCT06429553 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of a minimally invasive technique for aspirating and draining intracranial hematomas, combined with urokinase injection, on the prognosis of patients with spontaneous intracerebral hemorrhage. The focus is on patients with small to medium-sized hematomas, specifically those with a volume between 20-40 mL. The study aims to determine whether this approach can improve neurological outcomes compared to traditional conservative treatments. Participants will be monitored for changes in their neurological function and overall recovery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with a diagnosed intracerebral hemorrhage in the basal ganglia and specific hematoma volume criteria.

Not a fit: Patients with larger hematomas, those with severe neurological impairment, or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved recovery and reduced neurological impairment for patients suffering from spontaneous cerebral hemorrhage.

How similar studies have performed: Other studies have shown promise with minimally invasive techniques for hematoma management, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Aged 18-80 years;
2. ICH in the basal ganglia was diagnosed by CT examination of the head (bleeding mainly from the caudate nucleus, lentiform nucleus, clavate nucleus or amygdala);
3. Based on CT examination of the head, the volume of hematoma was calculated to be 20-40 mL, and the midline structure was shifted horizontally in the pineal gland \< 3 mm; The calculation formula of hematoma volume V (cm3) = A\*B\*C\*1/2, where A is the longest diameter (cm) of the largest level of hematoma in the horizontal CT scan, B is the widest diameter (cm) of the hematoma in the plane perpendicular to A, and C is the thickness (cm) of the hematoma in the CT film;
4. The time from onset to randomization is within 48 hours;
5. GCS score 4-14 points during randomization;
6. NIHSS score \>= 6 points during randomization;
7. Muscle strength of unilateral limbs on the symptomatic side is grade 0-3;
8. mRS0-1 score before onset;
9. Systolic blood pressure was controlled below 180mmHg before randomization;
10. Written informed consent signed by the patient and his legal representative.

Exclusion Criteria:

1. Bleeding in other areas (such as the thalamus, brain stem, or cerebellum);
2. Bleeding caused by other causes (such as aneurysm, arteriovenous malformation, brain trauma, brain tumor, hemorrhage transformation of massive cerebral infarction, hemorrhage caused by amyloidosis, hemorrhage caused by coagulation disorder) or combined with aneurysm, arteriovenous malformation, brain trauma, brain tumor, massive cerebral infarction, amyloidosis, severe coagulation disorder;
3. Recent history of cerebral hemorrhage (\< 1 year);
4. Multiple intracranial hemorrhage;
5. The CTA source map indicated early signs of expanded intracerebral hemorrhage hematoma (point sign), and the possibility of progressive hemorrhage was largely ruled out;
6. Patients with ventricular hemorrhage or ICH intrusion into the ventricle should be considered for external ventricular drainage;
7. Any history of parenchyma or other intracranial subarachnoid, subdural or epidural blood and surgical history within the last 30 days;
8. Patients with coagulation dysfunction such as hereditary or acquired bleeding constitution and lack of coagulation factor;
9. Hemoglobin \< 100 g/L, hematocrit \< 25%, platelet count \< 100\*10\^9/L;
10. Were receiving anticoagulant drugs such as warfarin, dabigatran or rivaroxaban within one week before enrollment, with INR \> 1.4;
11. Long-term anticoagulant and antiplatelet therapy is expected;
12. There is a history of internal bleeding, such as digestive tract bleeding, urogenital system bleeding, respiratory tract bleeding is not completely controlled;
13. Myocardial infarction within the last 30 days;
14. Known high risk of embolism, including patients with mechanical heart valve implantation, history of left heart thrombosis, mitral stenosis with atrial fibrillation, acute pericarditis, or subacute bacterial endocarditis. Atrial fibrillation without mitral stenosis is suitable;
15. Severe liver function damage, ALT \> 3 times the upper limit of normal, or AST \> 3 times the upper limit of normal. Severe renal insufficiency, glomerular filtration rate \< 30 ml/min/1.73m2;
16. Hypertension that could not be effectively controlled by active antihypertensive therapy before randomization (systolic blood pressure was still greater than 180 mmHg);
17. Patients with Alzheimer's disease or mental illness are unable to complete the follow-up plan as required;
18. Combined with any serious diseases that may be assessed to interfere with the test results: including diseases of the respiratory system, circulatory system, digestive system, genitourinary system, endocrine system, immune system and blood system;
19. Those who currently have drug or alcohol abuse or dependence and are expected to have poor compliance and difficulty in completing follow-up;
20. Allergic to urokinase or surgery-related drugs and instruments;
21. Pregnant or lactating women, or those planning to become pregnant within one year;
22. Life expectancy of \< 12 months due to advanced stage of any disease;
23. Are participating in other clinical trials or have been included in this trial in the previous stage;
24. The patient or his legal guardian is not willing to sign a written informed consent (YNMT).

Where this trial is running

Hefei, Anhui

• Hao Xu — Hefei, Anhui, China (Recruiting)

Conditions Spontaneous Cerebral Hemorrhage; Spontaneous cerebral hemorrhage; intracranial hematoma aspiration; urokinase