Clinical trial NCT03957707: Sterotactic Operation Integrating With Thrombolysis in Basal Ganglion Hemorrhage Evacuation
Official title: Sterotactic Operation Integrating With Thrombolysis in Basal Ganglion Hemorrhage Evacuation: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Basal Ganglia Haematoma
Keywords: basal ganglion hemorrhage
stereotactic surgery
thrombolysis
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Sir Run Run Shaw Hospital
name: Ningbo No. 1 Hospital
name: Ningbo Medical Center Lihuili Hospital
name: Second Affiliated Hospital of Wenzhou Medical University
name: Affiliated Wenling Hospital of Wenzhou Medical University
name: Affiliated Zhuji Hospital of Wenzhou Medical University
name: Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
name: Jinhua Central Hospital
name: Huizhou Municipal Central Hospital
name: People's Hospital of Quzhou
name: The Sixth Affiliated Hospital of Wenzhou Medical University
name: The Second Affiliated Hospital of Jiaxing University
First posted: 2019-05-21
Enrollment: 360
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. Our hospital has much experience in treating cerebral hemorrhage with stereotactic puncture and aspiration. So we conduct a prospective multicenter randomized controlled clinical trial to determine the therapeutic effects of puncture aspiration plus thrombolysis treatment for the perioperative and long-term recovery of patients with small to moderate hematoma in deep basal ganglia via computerized precision coordinates and personalized approach design.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of spontaneous basal ganglia hemorrhage by imaging (CT, CTA, etc.) with a volume \< 30 mL calculated by ABC/2 formula and Glasgow Coma Scale score ≥ 9.
2. With dysfunction such as hematoma-related motor aphasia, sensory aphasia, hemiplegic limb muscle strength ≤ grade 3 or NIHSS score ≥ 15 points.
3. Hematoma stability shown by a CT scan at least 6 hours after the diagnostic CT (hematoma volume increase \< 5 ml by ABC/2 formula)
4. Diagnostic CT scan 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 should be performed within 72 hours after onset.
7. SBP \<180 mmHg maintained for 6 hours prior to randomization.
8. Age between 18-70 years old.
9. mRS score ≤ 1 in past medical history.
10. Patients who are suitable and willing to be randomized to "puncture aspiration + urokinase" or conservative medical treatment.

Exclusion Criteria:

1. Hematoma involves other structures such as the thalamus and midbrain.
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 as well as 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 unsteady 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 occurring in the vascular puncture site or transvenous approach (eg. arterial puncture, venous incision, etc. ) or in the recent surgical site.
10. May be pregnant in the near future or already pregnant.
11. Previously enrolled in this study.
12. 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 may 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. Investigators believe co-morbidities would be detrimental to the patient when the study begins.
18. Patients difficult to follow up or with 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 + urokinase" treatment.

Primary outcomes:
measure: The change of ADL score
timeFrame: 6 months
measure: improvement of muscle strength of the hemiplegic limb or aphasia
timeFrame: 6 months
measure: Changes in GOS score
timeFrame: 6 months
Secondary outcomes:
measure: Mortality rate
timeFrame: 6 months
measure: Hematoma clearance rate
timeFrame: 1 day and one month
measure: Change in GCS score
timeFrame: one month
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: