Stereotactic Operation Integrating With Thrombolysis in Basal Ganglion Hemorrhage Evacuation II

NCT04172376 | Unknown DMC

• 1 other identifier: 2019-330
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Basal Ganglia Hemorrhage

Keywords

basal ganglion hemorrhage; stereotactic surgery; thrombolysis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Hematoma clearance rate

  at 1 day and 1 month after treatment

• Change in GCS score

  at 1 month after treatment

• 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

  at 6 months after treatment

Study Arms (2)

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

Interventions

Minimally invasive puncture aspiration plus rt-PA PROCEDURE

Stereotactic puncture aspiration to evacuate basal ganglion hematoma with use of thrombolytic agent

Minimally invasive puncture aspiration plus rt-PA

Conservative medical treatment DRUG

Drugs for symptomatic treatment such as hemostasis and nerve nourishing.

Conservative medical treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Huashan Hospital: collaborator
• First Affiliated Hospital of Guangxi Medical University: collaborator
• Southern Medical University, China: collaborator
• China-Japan Friendship Hospital: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator
• Second Affiliated Hospital of Xi'an Jiaotong University: collaborator
• The Affiliated Hospital Of Southwest Medical University: collaborator
• Tibet Autonomous Region People's Hospital: collaborator
• The Second Affiliated Hospital of Harbin Medical University: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator
• The Affiliated Hospital of Inner Mongolia Medical University: collaborator
• General Hospital of Ningxia Medical University: collaborator
• Central South University: collaborator

Related Publications (15)

• 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.

  PMID: 31248666 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.

  PMID: 23592763 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.

  PMID: 15075717 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.

  PMID: 20056489 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.

  PMID: 28052979 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.

  PMID: 16168935 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.

  PMID: 21158512 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.

  PMID: 15680453 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.

  PMID: 23726393 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.

  PMID: 26871205 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.

  PMID: 19236490 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.

  PMID: 27751554 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.

  PMID: 23391763 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.

  PMID: 30739747 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.

  PMID: 19763212 BACKGROUND

MeSH Terms

Conditions

Basal Ganglia Hemorrhage

Condition Hierarchy (Ancestors)

Basal Ganglia Cerebrovascular Disease; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebrovascular Disorders; Cerebral Hemorrhage; Intracranial Hemorrhages; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: November 21, 2019
• Study Start: January 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: December 19, 2020

Record last verified: 2020-12