The Treatment Effect of Endoscopic Evacuation Versus Suboccipital Craniotomy for Spontaneous Intracerebellar Hemorrhage.
NCT ID: NCT04991233
Last Updated: 2021-08-05
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
190 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-03-01
Study Completion Date
2024-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Posterior Fossa Hemorrhage
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
The grouping was blind to the investigators performing the follow-up and the statistical analysis
Study Groups
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Endoscopic surgery
Endoscopic surgery group
Group Type
EXPERIMENTAL
Endoscopic surgery
Intervention Type
PROCEDURE
The endoscopic surgery will be conducted to evacuate the hemorrhage within 24 hours after SCH.
Suboccipital craniotomy surgery
Suboccipital craniotomy surgery group
Group Type
ACTIVE_COMPARATOR
Suboccipital craniotomy surgery
Intervention Type
PROCEDURE
The suboccipital craniotomy surgery will be conducted to evacuate the hemorrhage within 24 hours after SCH.
Interventions
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Endoscopic surgery
The endoscopic surgery will be conducted to evacuate the hemorrhage within 24 hours after SCH.
Intervention Type
PROCEDURE
Suboccipital craniotomy surgery
The suboccipital craniotomy surgery will be conducted to evacuate the hemorrhage within 24 hours after SCH.
Intervention Type
PROCEDURE
Eligibility Criteria
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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.
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.
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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Tang-Du Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Yan Qu, M.D Ph.D
Role: STUDY_CHAIR
Tang-Du Hospital
Wei Guo, M.D Ph.D
Role: STUDY_DIRECTOR
Tang-Du Hospital
Locations
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Tandu Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China
Site Status
RECRUITING
Countries
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China
Central Contacts
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Facility Contacts
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References
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Li L, Liu H, Luo J, Tan Z, Gao J, Wang P, Jing W, Fan R, Zhang X, Guo H, Bai H, Cui W, Wu X, Qu Y, Guo W. Comparison of Long-Term Outcomes of Endoscopic and Minimally Invasive Catheter Evacuation for the Treatment of Spontaneous Cerebellar Hemorrhage. Transl Stroke Res. 2021 Feb;12(1):57-64. doi: 10.1007/s12975-020-00827-8. Epub 2020 Jul 4.
Reference Type
BACKGROUND
Heros RC. Cerebellar hemorrhage and infarction. Stroke. 1982 Jan-Feb;13(1):106-9. doi: 10.1161/01.str.13.1.106. No abstract available.
Reference Type
BACKGROUND
Lui TN, Fairholm DJ, Shu TF, Chang CN, Lee ST, Chen HR. Surgical treatment of spontaneous cerebellar hemorrhage. Surg Neurol. 1985 Jun;23(6):555-8. doi: 10.1016/0090-3019(85)90002-3.
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BACKGROUND
Kirollos RW, Tyagi AK, Ross SA, van Hille PT, Marks PV. Management of spontaneous cerebellar hematomas: a prospective treatment protocol. Neurosurgery. 2001 Dec;49(6):1378-86; discussion 1386-7. doi: 10.1097/00006123-200112000-00015.
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Datar S, Rabinstein AA. Cerebellar hemorrhage. Neurol Clin. 2014 Nov;32(4):993-1007. doi: 10.1016/j.ncl.2014.07.006. Epub 2014 Sep 11.
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Chang CY, Lin CY, Chen LC, Sun CH, Li TY, Tsai TH, Chang ST, Wu YT. The Predictor of Mortality within Six-Months in Patients with Spontaneous Cerebellar Hemorrhage: A Retrospective Study. PLoS One. 2015 Jul 17;10(7):e0132975. doi: 10.1371/journal.pone.0132975. eCollection 2015.
Reference Type
BACKGROUND
Da Pian R, Bazzan A, Pasqualin A. Surgical versus medical treatment of spontaneous posterior fossa haematomas: a cooperative study on 205 cases. Neurol Res. 1984 Sep;6(3):145-51. doi: 10.1080/01616412.1984.11739680.
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van Loon J, Van Calenbergh F, Goffin J, Plets C. Controversies in the management of spontaneous cerebellar haemorrhage. A consecutive series of 49 cases and review of the literature. Acta Neurochir (Wien). 1993;122(3-4):187-93. doi: 10.1007/BF01405527.
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Firsching R, Huber M, Frowein RA. Cerebellar haemorrhage: management and prognosis. Neurosurg Rev. 1991;14(3):191-4. doi: 10.1007/BF00310656.
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St Louis EK, Wijdicks EF, Li H, Atkinson JD. Predictors of poor outcome in patients with a spontaneous cerebellar hematoma. Can J Neurol Sci. 2000 Feb;27(1):32-6. doi: 10.1017/s0317167100051945.
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Lee JH, Kim DW, Kang SD. Stereotactic burr hole aspiration surgery for spontaneous hypertensive cerebellar hemorrhage. J Cerebrovasc Endovasc Neurosurg. 2012 Sep;14(3):170-4. doi: 10.7461/jcen.2012.14.3.170. Epub 2012 Sep 28.
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Li L, Li Z, Li Y, Su R, Wang B, Gao L, Yang Y, Xu F, Zhang X, Tian Q, Zhang X, Guo Q, Chang T, Luo T, Qu Y. Surgical Evacuation of Spontaneous Cerebellar Hemorrhage: Comparison of Safety and Efficacy of Suboccipital Craniotomy, Stereotactic Aspiration, and Thrombolysis and Endoscopic Surgery. World Neurosurg. 2018 Sep;117:e90-e98. doi: 10.1016/j.wneu.2018.05.170. Epub 2018 Jun 1.
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Meschia JF, Bushnell C, Boden-Albala B, Braun LT, Bravata DM, Chaturvedi S, Creager MA, Eckel RH, Elkind MS, Fornage M, Goldstein LB, Greenberg SM, Horvath SE, Iadecola C, Jauch EC, Moore WS, Wilson JA; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; Council on Functional Genomics and Translational Biology; Council on Hypertension. Guidelines for the primary prevention of stroke: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Dec;45(12):3754-832. doi: 10.1161/STR.0000000000000046. Epub 2014 Oct 28.
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Steiner T, Al-Shahi Salman R, Beer R, Christensen H, Cordonnier C, Csiba L, Forsting M, Harnof S, Klijn CJ, Krieger D, Mendelow AD, Molina C, Montaner J, Overgaard K, Petersson J, Roine RO, Schmutzhard E, Schwerdtfeger K, Stapf C, Tatlisumak T, Thomas BM, Toni D, Unterberg A, Wagner M; European Stroke Organisation. European Stroke Organisation (ESO) guidelines for the management of spontaneous intracerebral hemorrhage. Int J Stroke. 2014 Oct;9(7):840-55. doi: 10.1111/ijs.12309. Epub 2014 Aug 24.
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BACKGROUND
Other Identifiers
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TDSJWK-SCH-EESC-RCT
Identifier Type: -
Identifier Source: org_study_id
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