Clinical trial NCT04991233: The Treatment Effect of Endoscopic Evacuation Versus Suboccipital Craniotomy for Spontaneous Intracerebellar Hemorrhage.
Official title: The Effectiveness and Safety of Endoscopic Evacuation Versus Suboccipital Craniotomy in the Treatment of Spontaneous Intracerebellar Hemorrhage (SCH) -a Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Posterior Fossa Hemorrhage
Keywords: Posterior Fossa Hemorrhage
Endoscopic Surgery
Suboccipital Craniotomy
Treatment Outcome
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the present study is to compare the effectiveness and safety of two surgery evacuation methods (endoscopic surgery and suboccipital craniotomy) in the treatment of acute spontaneous cerebellar hemorrhage (SCH). A multi-center randomized control trial will be conducted. Patients with an initial GCS score of 5-14 will be screened and enrolled in the first 24 hours after SCH.

Detailed description: Spontaneous cerebellar hemorrhage (SCH) accounts for about 9-10% of all ICH cases, with a mortality rate of 20-50%. Suboccipital craniotomy was the traditional surgery method in the treatment of SCH. Minimally invasive techniques, including endoscopic evacuation and minimally invasive catheter (MIC) evacuation, have been used for the treatment of SCH) in recent years. However, credible evidence is still needed to validate the effects of these techniques. The treatment effect of endoscopic evacuation and MIC evacuation was compared in our previous study, results showed that the endoscopic evacuation significantly decreased the 6-month mortality of SCH patients. Thus endoscopic evacuation might be a safer and more effective option in the treatment of SCH. Therefore, in the current study, a multi-center randomized control trial will be conducted to compare the effectiveness and safety of endoscopic surgery and suboccipital craniotomy in the treatment of acute SCH. A multi-center randomized control trial will be conducted. Patients with an initial GCS score of 5-14 will be screened according to the selecting criteria. The enrolled patients will undertake the surgery within the first 24 hours after SCH. The primary outcome is the 30-day mortality rate. And the secondary outcomes including the 6-month mRS, the incidence of adverse events within 30-day, the hematoma clearance rate, the residual hematoma volume on postoperative day 1/3/7, and the perihematoma edema volume on postoperative day 1/3/7.

Eligibility criteria: Inclusion Criteria:

1. Aged 18-80 years old;
2. Cerebellar hemorrhage was confirmed by computed tomography (CT) scans;
3. The hematoma was \> 3 cm in diameter or the hematoma volume was \> 10ml or the hemorrhage is associated with brainstem compression or hydrocephalus;
4. The randomization can be conducted within 24 hours;
5. GCS score at randomization was 5-14;
6. mRS was 0-1 before onset;
7. The systolic pressure was controlled below 180 mmHg before randomization;
8. Informed consent was obtained from the patient and his legal representative.

Exclusion Criteria:

1. Coexistent intracranial bleeding from other sites;
2. Brain herniation before randomization;
3. Bleeding caused by other reasons such as aneurysm, arteriovenous malformation, trauma, and tumor; hemorrhage secondary to large cerebral infarction, beta-amyloid degeneration disease, or coagulation dysfunction; coexistent aneurysm, arteriovenous malformation, brain trauma, brain tumors, large area cerebral infarction, beta-amyloid degeneration disease, or serious blood coagulation disorders;
4. A history of cerebral hemorrhage within 1 year;
5. A history of intracranial surgery or hemorrhagic disease (intracerebral hemorrhage, subarachnoid hemorrhage, subdural or epidural hemorrhage) within the last 30 days;
6. Hemoglobin \< 100g/L, hematocrit \< 25%, platelet count \<100\*10\^9/L;
7. Warfarin, dabigatran, rivaroxaban, and other anticoagulant drugs were given within one week before enrollment, and the INR was \> 1.4;
8. Aspirin, clopidogrel, ticagrelor, and other antiplatelet drugs were given within one week before enrollment, and the inhibition rate of AA-dependent pathway \> 50%，inhibition rate of ADP-dependent pathway \> 30%;
9. Long-term anticoagulation and antiplatelet therapy is needed;
10. A history of internal bleeding that is not completely controlled, such as gastrointestinal bleeding, genitourinary bleeding, respiratory bleeding;
11. Myocardial infarction within 30 days;
12. Patients with high risks of embolization (a history of mechanical heart valve implantation, left ventricular thrombosis, mitral stenosis with atrial fibrillation, acute pericarditis, or subacute bacterial endocarditis); atrial fibrillation without mitral stenosis is acceptable;
13. Severely impaired liver function (ALT \> 3 times the normal upper limit, or AST \> 3 times the normal upper limit); severely impaired renal function (glomerular filtration rate \< 30ml/min/1.73m2);
14. Hypertension could not be effectively controlled before randomization (systolic blood pressure ≥ 180 mmHg);
15. Patients cannot complete the follow-up due to Alzheimer's disease or mental illness;
16. Coexistent serious diseases of the respiratory, circulatory, digestive, urogenital, endocrine, immune, and blood systems that are likely to interfere with the results;
17. Patients with current drug/alcohol abuse or dependence, or expected to have poor compliance and difficult to complete the follow-up;
18. Allergic to the drugs or instruments used in surgery;
19. Patients with surgery contraindications, or the other factors that may preclude implementation of the study protocol;
20. Pregnant or lactating women;
21. Life expectancy \< 12 months due to any advanced stage of disease;
22. Patient is participating in other clinical trials;
23. The legal guardian of the patient is unwilling to sign the written informed consent;
24. Assessed unsuitable for inclusion by investigators.

Primary outcomes:
measure: Mortality Rate
timeFrame: Within 30 days after SCH
Secondary outcomes:
measure: mRS Score
timeFrame: Within 6 months after SCH
measure: Adverse Events
timeFrame: Within 30 days after SCH
measure: Residual Hematoma Volume
timeFrame: Within 7 days after SCH
measure: Perihematoma Edema Volume
timeFrame: Within 7 days after SCH
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Tandu Hospital, Fourth Military Medical University
state: Shaanxi
Study officials:
affiliation: Tang-Du Hospital
name: Yan Qu, M.D Ph.D
role: STUDY_CHAIR
affiliation: Tang-Du Hospital
name: Wei Guo, M.D Ph.D
role: STUDY_DIRECTOR
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