Posterior Fossa HemorrhageNCT04991233
The Treatment Effect of Endoscopic Evacuation Versus Suboccipital Craniotomy for Spontaneous Intracerebellar Hemorrhage.
A study testing Endoscopic surgery and Suboccipital craniotomy surgery in people with Posterior Fossa Hemorrhage, run by Tang-Du Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Posterior Fossa Hemorrhage
- What is being tested?
- Endoscopic surgery and Suboccipital craniotomy surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-80 years old;
- Cerebellar hemorrhage was confirmed by computed tomography (CT) scans;
- The hematoma was > 3 cm in diameter or the hematoma volume was > 10ml or the hemorrhage is associated with brainstem compression or hydrocephalus;
- The randomization can be conducted within 24 hours;
- GCS score at randomization was 5-14;
- mRS was 0-1 before onset;
- The systolic pressure was controlled below 180 mmHg before randomization;
- Informed consent was obtained from the patient and his legal representative.
Who cannot join
- Coexistent intracranial bleeding from other sites;
- Brain herniation before randomization;
- 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;
- A history of cerebral hemorrhage within 1 year;
- A history of intracranial surgery or hemorrhagic disease (intracerebral hemorrhage, subarachnoid hemorrhage, subdural or epidural hemorrhage) within the last 30 days;
- Hemoglobin < 100g/L, hematocrit < 25%, platelet count <100*10^9/L;
Show all 24Show fewer
- Warfarin, dabigatran, rivaroxaban, and other anticoagulant drugs were given within one week before enrollment, and the INR was > 1.4;
- 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%;
- Long-term anticoagulation and antiplatelet therapy is needed;
- A history of internal bleeding that is not completely controlled, such as gastrointestinal bleeding, genitourinary bleeding, respiratory bleeding;
- Myocardial infarction within 30 days;
- 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;
- 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);
- Hypertension could not be effectively controlled before randomization (systolic blood pressure ≥ 180 mmHg);
- Patients cannot complete the follow-up due to Alzheimer's disease or mental illness;
- Coexistent serious diseases of the respiratory, circulatory, digestive, urogenital, endocrine, immune, and blood systems that are likely to interfere with the results;
- Patients with current drug/alcohol abuse or dependence, or expected to have poor compliance and difficult to complete the follow-up;
- Allergic to the drugs or instruments used in surgery;
- Patients with surgery contraindications, or the other factors that may preclude implementation of the study protocol;
- Pregnant or lactating women;
- Life expectancy < 12 months due to any advanced stage of disease;
- Patient is participating in other clinical trials;
- The legal guardian of the patient is unwilling to sign the written informed consent;
- Assessed unsuitable for inclusion by investigators.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tandu Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710038
Wei Guo, M.D Ph.D, 86-18729985168, 18729985168@163.com
Haixiao Liu, M.D, 86-15929315407, 56761311@qq.com
About this study
Official title: The Effectiveness and Safety of Endoscopic Evacuation Versus Suboccipital Craniotomy in the Treatment of Spontaneous Intracerebellar Hemorrhage (SCH) -a Randomized Control Trial.
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.
Read the 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.
- Conditions
- Posterior Fossa Hemorrhage
- Being tested
- Endoscopic surgery, Suboccipital craniotomy surgery
- Keywords
- Posterior Fossa Hemorrhage, Endoscopic Surgery, Suboccipital Craniotomy, Treatment Outcome
- Medical subject headings
- Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic surgeryProcedure or surgery
The endoscopic surgery will be conducted to evacuate the hemorrhage within 24 hours after SCH.
Suboccipital craniotomy surgeryProcedure or surgery
The suboccipital craniotomy surgery will be conducted to evacuate the hemorrhage within 24 hours after SCH.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic surgery | Experimental | Endoscopic surgery group Receives: Procedure: Endoscopic surgery |
| Suboccipital craniotomy surgery | Active comparator | Suboccipital craniotomy surgery group Receives: Procedure: Suboccipital craniotomy surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality Rate
The mortality rate in each group at 30 days after SCH.
Measured: Within 30 days after SCH
Secondary outcomes (4)
mRS Score
The mortality rate in each group at 6 months after SCH.
Measured: Within 6 months after SCH
Adverse Events
The Incidence of adverse events within 30 days after SCH.
Measured: Within 30 days after SCH
Residual Hematoma Volume
The residual hematoma volume on postoperative day 1, day 3 and day 7.
Measured: Within 7 days after SCH
Perihematoma Edema Volume
The perihematoma edema volume on postoperative day 1, day 3 and day 7.
Measured: Within 7 days after SCH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start1 Mar 2021
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Posterior Fossa HemorrhageStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Qu, M.D Ph.D, Study chair, Tang-Du HospitalWei Guo, M.D Ph.D, Study director, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04991233
- Sponsor's protocol ID
- TDSJWK-SCH-EESC-RCT
- Status last verified
- Aug 2021
- First submitted
- 7 Apr 2021
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32623579Heros RC. Cerebellar hemorrhage and infarction. Stroke. 1982 Jan-Feb;13(1):106-9. doi: 10.1161/01.str.13.1.106. No abstract available.
PubMed 7039001Lui 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.
PubMed 3992454Kirollos 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.
PubMed 11846937Datar 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.
PubMed 25439293Chang 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.
PubMed 26186721Da 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.
PubMed 6151139van 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.
PubMed 8372706Firsching R, Huber M, Frowein RA. Cerebellar haemorrhage: management and prognosis. Neurosurg Rev. 1991;14(3):191-4. doi: 10.1007/BF00310656.
PubMed 1944934St 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.
PubMed 10676585Lee 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.
PubMed 23210043Li 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.
PubMed 29864571Meschia 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.
PubMed 25355838Hemphill JC 3rd, Greenberg SM, Anderson CS, Becker K, Bendok BR, Cushman M, Fung GL, Goldstein JN, Macdonald RL, Mitchell PH, Scott PA, Selim MH, Woo D; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology. Guidelines for the Management of Spontaneous Intracerebral Hemorrhage: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2015 Jul;46(7):2032-60. doi: 10.1161/STR.0000000000000069. Epub 2015 May 28.
PubMed 26022637Steiner 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.
PubMed 25156220
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Safety of Endoscopic Evacuation Versus Suboccipital Craniotomy in the Treatment of Spontaneous Intracerebellar Hemorrhage (SCH) -a Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT04991233
- Acronym / sponsor ID
- TDSJWK-SCH-EESC-RCT
- Conditions
- Posterior Fossa Hemorrhage
- Keywords
- Posterior Fossa Hemorrhage, Endoscopic Surgery, Suboccipital Craniotomy, Treatment Outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic surgery | Experimental | Procedure: Endoscopic surgeryEndoscopic surgery group |
| Suboccipital craniotomy surgery | Active comparator | Procedure: Suboccipital craniotomy surgerySuboccipital craniotomy surgery group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 18-80 years old;
- Cerebellar hemorrhage was confirmed by computed tomography (CT) scans;
- The hematoma was > 3 cm in diameter or the hematoma volume was > 10ml or the hemorrhage is associated with brainstem compression or hydrocephalus;
- The randomization can be conducted within 24 hours;
- GCS score at randomization was 5-14;
Key exclusion criteria (24 listed)
- Coexistent intracranial bleeding from other sites;
- Brain herniation before randomization;
- 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;
- A history of cerebral hemorrhage within 1 year;
- A history of intracranial surgery or hemorrhagic disease (intracerebral hemorrhage, subarachnoid hemorrhage, subdural or epidural hemorrhage) within the last 30 days;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic surgeryThe endoscopic surgery will be conducted to evacuate the hemorrhage within 24 hours after SCH. | Procedure or surgery | Endoscopic surgery |
| Suboccipital craniotomy surgeryThe suboccipital craniotomy surgery will be conducted to evacuate the hemorrhage within 24 hours after SCH. | Procedure or surgery | Suboccipital craniotomy surgery |
Primary outcome
Mortality Rate
Time frame: Within 30 days after SCH
The mortality rate in each group at 30 days after SCH.
4 secondary outcomes
mRS Score
Time frame: Within 6 months after SCH
Adverse Events
Time frame: Within 30 days after SCH
Residual Hematoma Volume
Time frame: Within 7 days after SCH
Perihematoma Edema Volume
Time frame: Within 7 days after SCH
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Background: PubMed 32623579Li 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.
- Background: PubMed 7039001Heros RC. Cerebellar hemorrhage and infarction. Stroke. 1982 Jan-Feb;13(1):106-9. doi: 10.1161/01.str.13.1.106. No abstract available.
- Background: PubMed 3992454Lui 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.
- Background: PubMed 11846937Kirollos 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.
- Background: PubMed 25439293Datar 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.
- Background: PubMed 26186721Chang 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.
- Background: PubMed 6151139Da 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.
- Background: PubMed 8372706van 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.
- Background: PubMed 1944934Firsching R, Huber M, Frowein RA. Cerebellar haemorrhage: management and prognosis. Neurosurg Rev. 1991;14(3):191-4. doi: 10.1007/BF00310656.
- Background: PubMed 10676585St 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.
- Background: PubMed 23210043Lee 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.
- Background: PubMed 29864571Li 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Qu, M.D Ph.D study chair
Tang-Du Hospital
Wei Guo, M.D Ph.D study director
Tang-Du Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic surgery and Suboccipital craniotomy surgery in people with Posterior Fossa Hemorrhage, run by Tang-Du Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Guo, M.D Ph.D (86-18729985168, 18729985168@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality Rate (time frame: Within 30 days after SCH). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04991233, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.