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| Name | Class |
|---|---|
| Huashan Hospital | OTHER |
| First Affiliated Hospital of Guangxi Medical University | OTHER |
| Southern Medical University, China | OTHER |
| China-Japan Friendship Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minimally invasive puncture aspiration plus rt-PA | Experimental |
| |
| Conservative medical treatment | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally invasive puncture aspiration plus rt-PA | Procedure | Stereotactic puncture aspiration to evacuate basal ganglion hematoma with use of thrombolytic agent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of ADL score | ADL: Activities of Daily Living, ranges from 0-100, a higher ADL score means a better situation. | at 6 months of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Hematoma clearance rate | 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. | at 1 month after treatment |
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Inclusion Criteria:
Exclusion Criteria:
Early termination criteria:
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.
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31248666 | Background | 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. | |
| 23592763 |
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| OTHER |
| The First Affiliated Hospital of Anhui Medical University | OTHER |
| Second Affiliated Hospital of Xi'an Jiaotong University | OTHER |
| The Affiliated Hospital Of Southwest Medical University | OTHER |
| Tibet Autonomous Region People's Hospital | OTHER |
| The Second Affiliated Hospital of Harbin Medical University | OTHER |
| First Affiliated Hospital of Xinjiang Medical University | OTHER |
| The Affiliated Hospital of Inner Mongolia Medical University | OTHER |
| General Hospital of Ningxia Medical University | OTHER |
| Central South University | OTHER |
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| Conservative medical treatment | Drug | Drugs for symptomatic treatment such as hemostasis and nerve nourishing. |
|
| Mortality rate | at 6 months of follow-up |
| Improvement of the muscle strength of the hemiplegic limbs and aphasia | 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. | at 6 months after treatment |
| Length of hospital stay | at 6 months after treatment |
| All costs of the hospital stay | at 6 months after treatment |
| Background |
| Chiu 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. |
| 15075717 | Background | Rincon F, Mayer SA. Novel therapies for intracerebral hemorrhage. Curr Opin Crit Care. 2004 Apr;10(2):94-100. doi: 10.1097/00075198-200404000-00003. |
| 20056489 | Background | van 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. |
| 28052979 | Background | Wang 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. |
| 16168935 | Background | Mayer SA, Rincon F. Treatment of intracerebral haemorrhage. Lancet Neurol. 2005 Oct;4(10):662-72. doi: 10.1016/S1474-4422(05)70195-2. |
| 21158512 | Background | Talacchi 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. |
| 15680453 | Background | Mendelow 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. |
| 23726393 | Background | Mendelow 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. |
| 26871205 | Background | Choo 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. |
| 19236490 | Background | Wang 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. |
| 27751554 | Background | Hanley 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. |
| 23391763 | Background | Mould 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. |
| 30739747 | Background | Hanley 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. |
| 19763212 | Background | Kim 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. |
| ID | Term |
|---|---|
| D020145 | Basal Ganglia Hemorrhage |
| ID | Term |
|---|---|
| D020144 | Basal Ganglia Cerebrovascular Disease |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002561 | Cerebrovascular Disorders |
| D002543 | Cerebral Hemorrhage |
| D020300 | Intracranial Hemorrhages |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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