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

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.

Study Overview

• Status: Recruiting
• Conditions: Spontaneous Cerebral Hemorrhage
• Intervention / Treatment: Procedure: Minimally invasive hematoma aspiration drainage combined with urokinase injection

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).

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230001
      • Recruiting
      • Hao Xu
      • Contact: Hao Xu, PhD; Phone Number: +8618019576586; Email: xuhao2021@ustc.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hematoma puncture group; Minimally invasive hematoma aspiration drainage combined with urokinase injection	Procedure: Minimally invasive hematoma aspiration drainage combined with urokinase injection; Minimally invasive hematoma aspiration drainage combined with urokinase injection
Sham Comparator: Drug conserved group	Procedure: Minimally invasive hematoma aspiration drainage combined with urokinase injection; Minimally invasive hematoma aspiration drainage combined with urokinase injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Rankin Scale score (mRS)（0-6）（ higher scores mean a worse outcome.）	Modified Rankin Scale score (mRS)（0-6）（ higher scores mean a worse outcome.）	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
volume of hematoma	volume of hematoma	2 weeks
National Institutes of Health Stroke Scale（NIHSS)（0-42）（ higher scores mean a better outcome.）	National Institutes of Health Stroke Scale（NIHSS)（0-42）（ higher scores mean a better outcome.）	6 months
Muscle strength classification change（0-5）（ higher scores mean a better outcome.）	Muscle strength classification change（0-5）（ higher scores mean a better outcome.）	6 months

Collaborators and Investigators

• Sponsor: Anhui Provincial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: May 5, 2024
• First Submitted That Met QC Criteria: May 23, 2024
• First Posted (Actual): May 28, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2024
• Last Update Submitted That Met QC Criteria: May 23, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: urokinase; Spontaneous cerebral hemorrhage; intracranial hematoma aspiration
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage; Hematoma
• Other Study ID Numbers: 2023KY135

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No