Basal Ganglia HemorrhageSOITBE IINCT04172376
Stereotactic Operation Integrating With Thrombolysis in Basal Ganglion Hemorrhage Evacuation II
A study testing Minimally invasive puncture aspiration plus rt-PA and Conservative medical treatment in people with Basal Ganglia Hemorrhage, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Basal Ganglia Hemorrhage
- What is being tested?
- Minimally invasive puncture aspiration plus rt-PA and Conservative medical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 30 Jun 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- With dysfunctions such as hematoma-related motor aphasia, sensory aphasia, hemiplegic limb muscle strength ≤ grade 3 or NIHSS score ≥ 15.
- Hematoma volume increase <5 ml by ABC/2 formula shown by an additional CT scan after at least 6 hours of the diagnostic CT.
- Diagnostic CT scans should be obtained within 24 hours after the onset of symptoms. Cases with unclear onset time should be excluded.
- Randomization within 72 hours after diagnostic CT.
- Surgery performed within 72 hours after onset.
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- SBP <180 mmHg recorded for 6 hours prior to randomization.
- Age between 18-70 years old.
- mRS score ≤ 1 in past medical history.
- Patients are suitable and willing to be randomized to puncture aspiration plus rt-PA or conventional drug treatment.
Who cannot join
- Hematoma involves thalamus, midbrain and other structures.
- Mass effect or hydrocephalus due to intraventricular hemorrhage.
- 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.
- Manifestation of early stage cerebral herniation such as ipsilateral pupil changes and midline shift exceeding 1 cm.
- Patients with unstable hematoma or with progression to intracranial hypertension syndrome.
- Patients with any irreversible coagulopathy or known coagulation disorders; platelet count < 100,000; INR > 1.4.
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- Patients requiring long-term use of anticoagulants.
- Patients taking dabigatran, apixaban, and/or rivaroxaban (or similar drugs of the same category) before symptoms arise.
- 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.
- Patients who may be pregnant in the near future or are already pregnant.
- Patients previously enrolled in this study.
- 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.
- Patients with an expected survival of less than 6 months.
- Patients with severe co-morbidity (including hepatic, renal, gastrointestinal, respiratory, cardiovascular, endocrine, immune and/or hematological disorders) which would affect the outcome assessment.
- Patients with mechanical heart valve. Biological valves are acceptable.
- 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.
- Patients with co-morbidities that would be detrimental if the study begins according to investigators.
- Lost to follow-up or poor compliance due to various reasons (such as geographical and social factors, drug or alcohol abuse, etc.)
- Patient or his or her legal guardian/representative is unable or unwilling to give the written informed consent.
- Patients is in a condition that is not suitable for puncture aspiration plus rt-PA treatment.
- Early termination criteria:
- Serious adverse events related to minimally invasive treatment
- 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.
About this study
Official title: Stereotactic Operation Integrating With Thrombolysis in Basal Ganglion Hemorrhage Evacuation II (SOITBE II)
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.
Read the detailed description
- 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.
- 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.
- Conditions
- Basal Ganglia Hemorrhage
- Being tested
- Minimally invasive puncture aspiration plus rt-PA, Conservative medical treatment
- Keywords
- basal ganglion hemorrhage, stereotactic surgery, thrombolysis
- Medical subject headings
- Basal Ganglia Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive puncture aspiration plus rt-PAProcedure or surgery
Stereotactic puncture aspiration to evacuate basal ganglion hematoma with use of thrombolytic agent
Conservative medical treatmentDrug
Drugs for symptomatic treatment such as hemostasis and nerve nourishing.
| Study group | Role | What they receive |
|---|---|---|
| Minimally invasive puncture aspiration plus rt-PA | Experimental | Not described Receives: Procedure: Minimally invasive puncture aspiration plus rt-PA |
| Conservative medical treatment | Active comparator | Not described Receives: Drug: Conservative medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of ADL score
ADL: Activities of Daily Living, ranges from 0-100, a higher ADL score means a better situation.
Measured: at 6 months of follow-up
Secondary outcomes (7)
Hematoma clearance rate
Measured: at 1 day and 1 month after treatment
Change in GCS score
GCS: Glasgow Coma Scale, ranges from 3-15, a higher GCS score means a better situation.
Measured: at 1 month after treatment
Mortality rate
Measured: at 6 months of follow-up
Improvement of the muscle strength of the hemiplegic limbs and aphasia
Measured: after 6 months of follow-up
Change in GCS score
GCS: Glasgow Coma Scale, ranges from 3-15, a higher GCS score means a better situation.
Measured: at 6 months after treatment
Length of hospital stay
Measured: at 6 months after treatment
All costs of the hospital stay
Measured: at 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start1 Jan 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Basal Ganglia HemorrhageStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Huashan Hospital, First Affiliated Hospital of Guangxi Medical University, Southern Medical University, China, China-Japan Friendship Hospital, The First Affiliated Hospital of Anhui Medical University, Second Affiliated Hospital of Xi'an Jiaotong University, The Affiliated Hospital Of Southwest Medical University, Tibet Autonomous Region People's Hospital, The Second Affiliated Hospital of Harbin Medical University, First Affiliated Hospital of Xinjiang Medical University, The Affiliated Hospital of Inner Mongolia Medical University, General Hospital of Ningxia Medical University, Central South University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172376
- Sponsor's protocol ID
- 2019-330
- Acronym
- SOITBE II
- Status last verified
- Dec 2020
- First submitted
- 21 Oct 2019
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhou M, Wang H, Zeng X, Yin P, Zhu J, Chen W, Li X, Wang L, Wang L, Liu Y, Liu J, Zhang M, Qi J, Yu S, Afshin A, Gakidou E, Glenn S, Krish VS, Miller-Petrie MK, Mountjoy-Venning WC, Mullany EC, Redford SB, Liu H, Naghavi M, Hay SI, Wang L, Murray CJL, Liang X. Mortality, morbidity, and risk factors in China and its provinces, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2019 Sep 28;394(10204):1145-1158. doi: 10.1016/S0140-6736(19)30427-1. Epub 2019 Jun 24.
PubMed 31248666Chiu CD, Chen CC, Shen CC, Chin LT, Ma HI, Chuang HY, Cho DY, Chu CH, Chang C. Hyperglycemia exacerbates intracerebral hemorrhage via the downregulation of aquaporin-4: temporal assessment with magnetic resonance imaging. Stroke. 2013 Jun;44(6):1682-9. doi: 10.1161/STROKEAHA.113.675983. Epub 2013 Apr 16.
PubMed 23592763Rincon F, Mayer SA. Novel therapies for intracerebral hemorrhage. Curr Opin Crit Care. 2004 Apr;10(2):94-100. doi: 10.1097/00075198-200404000-00003.
PubMed 15075717van Asch CJ, Luitse MJ, Rinkel GJ, van der Tweel I, Algra A, Klijn CJ. Incidence, case fatality, and functional outcome of intracerebral haemorrhage over time, according to age, sex, and ethnic origin: a systematic review and meta-analysis. Lancet Neurol. 2010 Feb;9(2):167-76. doi: 10.1016/S1474-4422(09)70340-0. Epub 2010 Jan 5.
PubMed 20056489Wang W, Jiang B, Sun H, Ru X, Sun D, Wang L, Wang L, Jiang Y, Li Y, Wang Y, Chen Z, Wu S, Zhang Y, Wang D, Wang Y, Feigin VL; NESS-China Investigators. Prevalence, Incidence, and Mortality of Stroke in China: Results from a Nationwide Population-Based Survey of 480 687 Adults. Circulation. 2017 Feb 21;135(8):759-771. doi: 10.1161/CIRCULATIONAHA.116.025250. Epub 2017 Jan 4.
PubMed 28052979Mayer SA, Rincon F. Treatment of intracerebral haemorrhage. Lancet Neurol. 2005 Oct;4(10):662-72. doi: 10.1016/S1474-4422(05)70195-2.
PubMed 16168935Talacchi A, Ricci UM, Caramia G, Massimo G. Basal ganglia haemorrhages: efficacy and limits of different surgical strategies. Br J Neurosurg. 2011 Apr;25(2):235-42. doi: 10.3109/02688697.2010.534203. Epub 2010 Dec 15.
PubMed 21158512Mendelow AD, Gregson BA, Fernandes HM, Murray GD, Teasdale GM, Hope DT, Karimi A, Shaw MD, Barer DH; STICH investigators. Early surgery versus initial conservative treatment in patients with spontaneous supratentorial intracerebral haematomas in the International Surgical Trial in Intracerebral Haemorrhage (STICH): a randomised trial. Lancet. 2005 Jan 29-Feb 4;365(9457):387-97. doi: 10.1016/S0140-6736(05)17826-X.
PubMed 15680453Mendelow AD, Gregson BA, Rowan EN, Murray GD, Gholkar A, Mitchell PM; STICH II Investigators. Early surgery versus initial conservative treatment in patients with spontaneous supratentorial lobar intracerebral haematomas (STICH II): a randomised trial. Lancet. 2013 Aug 3;382(9890):397-408. doi: 10.1016/S0140-6736(13)60986-1. Epub 2013 May 29.
PubMed 23726393Choo YS, Chung J, Joo JY, Kim YB, Hong CK. Borderline basal ganglia hemorrhage volume: patient selection for good clinical outcome after stereotactic catheter drainage. J Neurosurg. 2016 Nov;125(5):1242-1248. doi: 10.3171/2015.10.JNS151643. Epub 2016 Feb 12.
PubMed 26871205Wang WZ, Jiang B, Liu HM, Li D, Lu CZ, Zhao YD, Sander JW. Minimally invasive craniopuncture therapy vs. conservative treatment for spontaneous intracerebral hemorrhage: results from a randomized clinical trial in China. Int J Stroke. 2009 Feb;4(1):11-6. doi: 10.1111/j.1747-4949.2009.00239.x.
PubMed 19236490Hanley DF, Thompson RE, Muschelli J, Rosenblum M, McBee N, Lane K, Bistran-Hall AJ, Mayo SW, Keyl P, Gandhi D, Morgan TC, Ullman N, Mould WA, Carhuapoma JR, Kase C, Ziai W, Thompson CB, Yenokyan G, Huang E, Broaddus WC, Graham RS, Aldrich EF, Dodd R, Wijman C, Caron JL, Huang J, Camarata P, Mendelow AD, Gregson B, Janis S, Vespa P, Martin N, Awad I, Zuccarello M; MISTIE Investigators. Safety and efficacy of minimally invasive surgery plus alteplase in intracerebral haemorrhage evacuation (MISTIE): a randomised, controlled, open-label, phase 2 trial. Lancet Neurol. 2016 Nov;15(12):1228-1237. doi: 10.1016/S1474-4422(16)30234-4. Epub 2016 Oct 11.
PubMed 27751554Mould WA, Carhuapoma JR, Muschelli J, Lane K, Morgan TC, McBee NA, Bistran-Hall AJ, Ullman NL, Vespa P, Martin NA, Awad I, Zuccarello M, Hanley DF; MISTIE Investigators. Minimally invasive surgery plus recombinant tissue-type plasminogen activator for intracerebral hemorrhage evacuation decreases perihematomal edema. Stroke. 2013 Mar;44(3):627-34. doi: 10.1161/STROKEAHA.111.000411. Epub 2013 Feb 7.
PubMed 23391763Hanley DF, Thompson RE, Rosenblum M, Yenokyan G, Lane K, McBee N, Mayo SW, Bistran-Hall AJ, Gandhi D, Mould WA, Ullman N, Ali H, Carhuapoma JR, Kase CS, Lees KR, Dawson J, Wilson A, Betz JF, Sugar EA, Hao Y, Avadhani R, Caron JL, Harrigan MR, Carlson AP, Bulters D, LeDoux D, Huang J, Cobb C, Gupta G, Kitagawa R, Chicoine MR, Patel H, Dodd R, Camarata PJ, Wolfe S, Stadnik A, Money PL, Mitchell P, Sarabia R, Harnof S, Barzo P, Unterberg A, Teitelbaum JS, Wang W, Anderson CS, Mendelow AD, Gregson B, Janis S, Vespa P, Ziai W, Zuccarello M, Awad IA; MISTIE III Investigators. Efficacy and safety of minimally invasive surgery with thrombolysis in intracerebral haemorrhage evacuation (MISTIE III): a randomised, controlled, open-label, blinded endpoint phase 3 trial. Lancet. 2019 Mar 9;393(10175):1021-1032. doi: 10.1016/S0140-6736(19)30195-3. Epub 2019 Feb 7.
PubMed 30739747Kim YZ, Kim KH. Even in patients with a small hemorrhagic volume, stereotactic-guided evacuation of spontaneous intracerebral hemorrhage improves functional outcome. J Korean Neurosurg Soc. 2009 Aug;46(2):109-15. doi: 10.3340/jkns.2009.46.2.109. Epub 2009 Aug 31.
PubMed 19763212
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Operation Integrating With Thrombolysis in Basal Ganglion Hemorrhage Evacuation II (SOITBE II)
- ClinicalTrials.gov ID
- NCT04172376
- Acronym / sponsor ID
- SOITBE II / 2019-330
- Conditions
- Basal Ganglia Hemorrhage
- Keywords
- basal ganglion hemorrhage, stereotactic surgery, thrombolysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Huashan Hospital, First Affiliated Hospital of Guangxi Medical University, Southern Medical University, China, China-Japan Friendship Hospital, The First Affiliated Hospital of Anhui Medical University, Second Affiliated Hospital of Xi'an Jiaotong University, The Affiliated Hospital Of Southwest Medical University, Tibet Autonomous Region People's Hospital, The Second Affiliated Hospital of Harbin Medical University, First Affiliated Hospital of Xinjiang Medical University, The Affiliated Hospital of Inner Mongolia Medical University, General Hospital of Ningxia Medical University, Central South University
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 21 Nov 2019 (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.
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
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive puncture aspiration plus rt-PA | Experimental | Procedure: Minimally invasive puncture aspiration plus rt-PA |
| Conservative medical treatment | Active comparator | Drug: Conservative medical treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- With dysfunctions such as hematoma-related motor aphasia, sensory aphasia, hemiplegic limb muscle strength ≤ grade 3 or NIHSS score ≥ 15.
- Hematoma volume increase <5 ml by ABC/2 formula shown by an additional CT scan after at least 6 hours of the diagnostic CT.
- Diagnostic CT scans should be obtained within 24 hours after the onset of symptoms. Cases with unclear onset time should be excluded.
- Randomization within 72 hours after diagnostic CT.
Key exclusion criteria (27 listed)
- Hematoma involves thalamus, midbrain and other structures.
- Mass effect or hydrocephalus due to intraventricular hemorrhage.
- 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.
- Manifestation of early stage cerebral herniation such as ipsilateral pupil changes and midline shift exceeding 1 cm.
- Patients with unstable hematoma or with progression to intracranial hypertension syndrome.
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 |
|---|---|---|
| Minimally invasive puncture aspiration plus rt-PAStereotactic puncture aspiration to evacuate basal ganglion hematoma with use of thrombolytic agent | Procedure or surgery | Minimally invasive puncture aspiration plus rt-PA |
| Conservative medical treatmentDrugs for symptomatic treatment such as hemostasis and nerve nourishing. | Drug | Conservative medical treatment |
Primary outcome
Change of ADL score
Time frame: at 6 months of follow-up
ADL: Activities of Daily Living, ranges from 0-100, a higher ADL score means a better situation.
7 secondary outcomes
Hematoma clearance rate
Time frame: at 1 day and 1 month after treatment
Change in GCS score
Time frame: at 1 month after treatment
Mortality rate
Time frame: at 6 months of follow-up
Improvement of the muscle strength of the hemiplegic limbs and aphasia
Time frame: after 6 months of follow-up
Change in GCS score
Time frame: at 6 months after treatment
Length of hospital stay
Time frame: at 6 months after treatment
All costs of the hospital stay
Time frame: at 6 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Background: PubMed 31248666Zhou M, Wang H, Zeng X, Yin P, Zhu J, Chen W, Li X, Wang L, Wang L, Liu Y, Liu J, Zhang M, Qi J, Yu S, Afshin A, Gakidou E, Glenn S, Krish VS, Miller-Petrie MK, Mountjoy-Venning WC, Mullany EC, Redford SB, Liu H, Naghavi M, Hay SI, Wang L, Murray CJL, Liang X. Mortality, morbidity, and risk factors in China and its provinces, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2019 Sep 28;394(10204):1145-1158. doi: 10.1016/S0140-6736(19)30427-1. Epub 2019 Jun 24.
- Background: PubMed 23592763Chiu CD, Chen CC, Shen CC, Chin LT, Ma HI, Chuang HY, Cho DY, Chu CH, Chang C. Hyperglycemia exacerbates intracerebral hemorrhage via the downregulation of aquaporin-4: temporal assessment with magnetic resonance imaging. Stroke. 2013 Jun;44(6):1682-9. doi: 10.1161/STROKEAHA.113.675983. Epub 2013 Apr 16.
- Background: PubMed 15075717Rincon F, Mayer SA. Novel therapies for intracerebral hemorrhage. Curr Opin Crit Care. 2004 Apr;10(2):94-100. doi: 10.1097/00075198-200404000-00003.
- Background: PubMed 20056489van Asch CJ, Luitse MJ, Rinkel GJ, van der Tweel I, Algra A, Klijn CJ. Incidence, case fatality, and functional outcome of intracerebral haemorrhage over time, according to age, sex, and ethnic origin: a systematic review and meta-analysis. Lancet Neurol. 2010 Feb;9(2):167-76. doi: 10.1016/S1474-4422(09)70340-0. Epub 2010 Jan 5.
- Background: PubMed 28052979Wang W, Jiang B, Sun H, Ru X, Sun D, Wang L, Wang L, Jiang Y, Li Y, Wang Y, Chen Z, Wu S, Zhang Y, Wang D, Wang Y, Feigin VL; NESS-China Investigators. Prevalence, Incidence, and Mortality of Stroke in China: Results from a Nationwide Population-Based Survey of 480 687 Adults. Circulation. 2017 Feb 21;135(8):759-771. doi: 10.1161/CIRCULATIONAHA.116.025250. Epub 2017 Jan 4.
- Background: PubMed 16168935Mayer SA, Rincon F. Treatment of intracerebral haemorrhage. Lancet Neurol. 2005 Oct;4(10):662-72. doi: 10.1016/S1474-4422(05)70195-2.
- Background: PubMed 21158512Talacchi A, Ricci UM, Caramia G, Massimo G. Basal ganglia haemorrhages: efficacy and limits of different surgical strategies. Br J Neurosurg. 2011 Apr;25(2):235-42. doi: 10.3109/02688697.2010.534203. Epub 2010 Dec 15.
- Background: PubMed 15680453Mendelow AD, Gregson BA, Fernandes HM, Murray GD, Teasdale GM, Hope DT, Karimi A, Shaw MD, Barer DH; STICH investigators. Early surgery versus initial conservative treatment in patients with spontaneous supratentorial intracerebral haematomas in the International Surgical Trial in Intracerebral Haemorrhage (STICH): a randomised trial. Lancet. 2005 Jan 29-Feb 4;365(9457):387-97. doi: 10.1016/S0140-6736(05)17826-X.
- Background: PubMed 23726393Mendelow AD, Gregson BA, Rowan EN, Murray GD, Gholkar A, Mitchell PM; STICH II Investigators. Early surgery versus initial conservative treatment in patients with spontaneous supratentorial lobar intracerebral haematomas (STICH II): a randomised trial. Lancet. 2013 Aug 3;382(9890):397-408. doi: 10.1016/S0140-6736(13)60986-1. Epub 2013 May 29.
- Background: PubMed 26871205Choo YS, Chung J, Joo JY, Kim YB, Hong CK. Borderline basal ganglia hemorrhage volume: patient selection for good clinical outcome after stereotactic catheter drainage. J Neurosurg. 2016 Nov;125(5):1242-1248. doi: 10.3171/2015.10.JNS151643. Epub 2016 Feb 12.
- Background: PubMed 19236490Wang WZ, Jiang B, Liu HM, Li D, Lu CZ, Zhao YD, Sander JW. Minimally invasive craniopuncture therapy vs. conservative treatment for spontaneous intracerebral hemorrhage: results from a randomized clinical trial in China. Int J Stroke. 2009 Feb;4(1):11-6. doi: 10.1111/j.1747-4949.2009.00239.x.
- Background: PubMed 27751554Hanley DF, Thompson RE, Muschelli J, Rosenblum M, McBee N, Lane K, Bistran-Hall AJ, Mayo SW, Keyl P, Gandhi D, Morgan TC, Ullman N, Mould WA, Carhuapoma JR, Kase C, Ziai W, Thompson CB, Yenokyan G, Huang E, Broaddus WC, Graham RS, Aldrich EF, Dodd R, Wijman C, Caron JL, Huang J, Camarata P, Mendelow AD, Gregson B, Janis S, Vespa P, Martin N, Awad I, Zuccarello M; MISTIE Investigators. Safety and efficacy of minimally invasive surgery plus alteplase in intracerebral haemorrhage evacuation (MISTIE): a randomised, controlled, open-label, phase 2 trial. Lancet Neurol. 2016 Nov;15(12):1228-1237. doi: 10.1016/S1474-4422(16)30234-4. Epub 2016 Oct 11.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally invasive puncture aspiration plus rt-PA and Conservative medical treatment in people with Basal Ganglia Hemorrhage, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 10 inclusion and 27 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 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of ADL score (time frame: at 6 months of follow-up). 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 NCT04172376, which also lists 15 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 19 Dec 2020.