Clinical trial NCT04172376: Stereotactic Operation Integrating With Thrombolysis in Basal Ganglion Hemorrhage Evacuation II
Official title: Stereotactic Operation Integrating With Thrombolysis in Basal Ganglion Hemorrhage Evacuation II (SOITBE II)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Basal Ganglia Hemorrhage
Keywords: basal ganglion hemorrhage
stereotactic surgery
thrombolysis
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Huashan Hospital
name: First Affiliated Hospital of Guangxi Medical University
name: Southern Medical University, China
name: China-Japan Friendship Hospital
name: The First Affiliated Hospital of Anhui Medical University
name: Second Affiliated Hospital of Xi'an Jiaotong University
name: The Affiliated Hospital Of Southwest Medical University
name: Tibet Autonomous Region People's Hospital
name: The Second Affiliated Hospital of Harbin Medical University
name: First Affiliated Hospital of Xinjiang Medical University
name: The Affiliated Hospital of Inner Mongolia Medical University
name: General Hospital of Ningxia Medical University
name: Central South University
First posted: 2019-11-21
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Spontaneous cerebral hemorrhage is one of the main causes of death and disability all over the world, accounting for 20%-30% of all cerebrovascular diseases. Minimally invasive surgery of cerebral hemorrhage, especially puncture aspiration, can improve early and long-term neurological recovery in patients with cerebral hemorrhage. Until now, no standardized practice for minimally invasive surgery of spontaneous cerebral hemorrhage has been established. Hematoma puncture and drainage based on CT scans without precise localization and personalized approach design, which may lead to poor efficacy and high risk of complications. The investigators' hospital has much experience in treating cerebral hemorrhage with stereotactic puncture and aspiration. So the investigators conduct a prospective multicenter randomized controlled clinical trial across the country to determine the therapeutic effects of puncture aspiration plus thrombolysis treatment for the perioperative and long-term recovery of patients with small hematoma in deep basal ganglia via computerized precision coordinates and personalized approach design.

Detailed description: 1. Prospective enrollment of patients with small spontaneous basal ganglia hematoma according to the inclusion and exclusion criteria in 14 major neurosurgical centers across the country to establish a multi-center clinical database of spontaneous small basal ganglia hematoma with data maintenance and update.
2. Random allocation of the patients enrolled into control group (conservative treatment with conventional drugs) or intervention group (minimally invasive puncture aspiration plus rt-PA); long-term follow-up for 6 months to compare the recent and long-term mortality rate, disability rate and related complications of the two groups.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of spontaneous basal ganglia hemorrhage by imaging (CT, CTA, etc.) with a volume of 15-30 mL calculated by ABC/2 formula and Glasgow Coma Scale score of at least 9.
2. With dysfunctions such as hematoma-related motor aphasia, sensory aphasia, hemiplegic limb muscle strength ≤ grade 3 or NIHSS score ≥ 15.
3. Hematoma volume increase \<5 ml by ABC/2 formula shown by an additional CT scan after at least 6 hours of the diagnostic CT.
4. Diagnostic CT scans should be obtained within 24 hours after the onset of symptoms. Cases with unclear onset time should be excluded.
5. Randomization within 72 hours after diagnostic CT.
6. Surgery performed within 72 hours after onset.
7. SBP \<180 mmHg recorded for 6 hours prior to randomization.
8. Age between 18-70 years old.
9. mRS score ≤ 1 in past medical history.
10. Patients are suitable and willing to be randomized to puncture aspiration plus rt-PA or conventional drug treatment.

Exclusion Criteria:

1. Hematoma involves thalamus, midbrain and other structures.
2. Mass effect or hydrocephalus due to intraventricular hemorrhage.
3. Imaging-based diagnosis of cerebrovascular abnormalities such as ruptured aneurysm, arteriovenous malformation (AVM) and moyamoya disease, hemorrhagic transformation of ischemic infarct and recent recurrence (within 1 year) of cerebral hemorrhage.
4. Manifestation of early stage cerebral herniation such as ipsilateral pupil changes and midline shift exceeding 1 cm.
5. Patients with unstable hematoma or with progression to intracranial hypertension syndrome.
6. Patients with any irreversible coagulopathy or known coagulation disorders; platelet count \< 100,000; INR \> 1.4.
7. Patients requiring long-term use of anticoagulants.
8. Patients taking dabigatran, apixaban, and/or rivaroxaban (or similar drugs of the same category) before symptoms arise.
9. Bleeding in other sites, including retroperitoneal, gastrointestinal, genitourinary or respiratory tract bleeding; superficial or skin surface bleeding, mainly in the vascular puncture sites or transvenous approaches (e.g. arterial puncture, venous incision, etc.), or the recent surgical sites.
10. Patients who may be pregnant in the near future or are already pregnant.
11. Patients previously enrolled in this study.
12. Patients participating in other interventional medical research or clinical trials at the same time. Patients enrolled in observational, natural history and/or epidemiological studies (without intervention) are eligible for this trial.
13. Patients with an expected survival of less than 6 months.
14. Patients with severe co-morbidity (including hepatic, renal, gastrointestinal, respiratory, cardiovascular, endocrine, immune and/or hematological disorders) which would affect the outcome assessment.
15. Patients with mechanical heart valve. Biological valves are acceptable.
16. Patients with risk of embolism (including a history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis or subacute bacterial endocarditis). Atrial fibrillation without mitral stenosis is acceptable.
17. Patients with co-morbidities that would be detrimental if the study begins according to investigators.
18. Lost to follow-up or poor compliance due to various reasons (such as geographical and social factors, drug or alcohol abuse, etc.)
19. Patient or his or her legal guardian/representative is unable or unwilling to give the written informed consent.
20. Patients is in a condition that is not suitable for puncture aspiration plus rt-PA treatment.

Early termination criteria:

1. Serious adverse events related to minimally invasive treatment
2. Interim analysis shows a significant difference in efficacy between the conservative and surgical groups.

Dropout criteria:

Patients who cannot be followed up during the study period are considered dropout. Dropout patients are followed up by telephone, mail or outpatient visits and the reason for the dropout and the last follow-up information should be collected as much as possible.

Elimination criteria:

Patients whose disease-related biological or imaging data are not retained should be discussed for elimination by investigators and statisticians before final analysis.

Primary outcomes:
measure: Change of ADL score
timeFrame: at 6 months of follow-up
Secondary outcomes:
measure: Hematoma clearance rate
timeFrame: at 1 day and 1 month after treatment
measure: Change in GCS score
timeFrame: at 1 month after treatment
measure: Mortality rate
timeFrame: at 6 months of follow-up
measure: Improvement of the muscle strength of the hemiplegic limbs and aphasia
timeFrame: after 6 months of follow-up
measure: Change in GCS score
timeFrame: at 6 months after treatment
measure: Length of hospital stay
timeFrame: at 6 months after treatment
measure: All costs of the hospital stay
timeFrame: at 6 months after treatment
Other outcomes:
Locations:
Study officials:
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