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Sterotactic Operation Integrating With Thrombolysis in Basal Ganglion Hemorrhage Evacuation (SOITBE)

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ClinicalTrials.gov Identifier: NCT03957707
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

Tracking Information
First Submitted Date  ICMJE May 19, 2019
First Posted Date  ICMJE May 21, 2019
Last Update Posted Date May 21, 2019
Actual Study Start Date  ICMJE January 1, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2019)
  • The change of ADL score [ Time Frame: 6 months ]
  • improvement of muscle strength of the hemiplegic limb or aphasia [ Time Frame: 6 months ]
  • Changes in GOS score [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2019)
  • Mortality rate [ Time Frame: 6 months ]
  • Hematoma clearance rate [ Time Frame: 1 day and one month ]
  • Change in GCS score [ Time Frame: one month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sterotactic Operation Integrating With Thrombolysis in Basal Ganglion Hemorrhage Evacuation
Official Title  ICMJE Sterotactic Operation Integrating With Thrombolysis in Basal Ganglion Hemorrhage Evacuation: a Randomized Controlled Trial.
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. Our hospital has much experience in treating cerebral hemorrhage with stereotactic puncture and aspiration. So we conduct a prospective multicenter randomized controlled clinical trial to determine the therapeutic effects of puncture aspiration plus thrombolysis treatment for the perioperative and long-term recovery of patients with small to moderate hematoma in deep basal ganglia via computerized precision coordinates and personalized approach design.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Basal Ganglia Haematoma
Intervention  ICMJE Procedure: stereotactic surgery plus thrombolysis
stereotactic puncture and aspiration to evacuate basal ganglion hematoma with or without thrombolytic agent
Study Arms  ICMJE
  • Experimental: stereotactic surgery with drugs treatment
    Intervention: Procedure: stereotactic surgery plus thrombolysis
  • Sham Comparator: drugs treatment alone
    Intervention: Procedure: stereotactic surgery plus thrombolysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 19, 2019)
360
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Diagnosis of spontaneous basal ganglia hemorrhage by imaging (CT, CTA, etc.) with a volume < 30 mL calculated by ABC/2 formula and Glasgow Coma Scale score ≥ 9.
  2. With dysfunction such as hematoma-related motor aphasia, sensory aphasia, hemiplegic limb muscle strength ≤ grade 3 or NIHSS score ≥ 15 points.
  3. Hematoma stability shown by a CT scan at least 6 hours after the diagnostic CT (hematoma volume increase < 5 ml by ABC/2 formula)
  4. Diagnostic CT scan should be obtained within 24 hours after the onset of symptoms. Cases with unclear onset time should be excluded.
  5. Randomization within 72 hours after diagnostic CT.
  6. Surgery should be performed within 72 hours after onset.
  7. SBP <180 mmHg maintained for 6 hours prior to randomization.
  8. Age between 18-70 years old.
  9. mRS score ≤ 1 in past medical history.
  10. Patients who are suitable and willing to be randomized to "puncture aspiration + urokinase" or conservative medical treatment.

Exclusion Criteria:

  1. Hematoma involves other structures such as the thalamus and midbrain.
  2. Mass effect or hydrocephalus due to intraventricular hemorrhage.
  3. Imaging-based diagnosis of cerebrovascular abnormalities such as ruptured aneurysm, arteriovenous malformation (AVM) and moyamoya disease as well as hemorrhagic transformation of ischemic infarct and recent recurrence (within 1 year) of cerebral hemorrhage.
  4. Manifestation of early stage cerebral herniation such as ipsilateral pupil changes and midline shift exceeding 1 cm.
  5. Patients with unsteady hematoma or with progression to intracranial hypertension syndrome.
  6. Patients with any irreversible coagulopathy or known coagulation disorders; platelet count <100,000; INR > 1.4.
  7. Patients requiring long-term use of anticoagulants.
  8. Patients taking dabigatran, apixaban and/or rivaroxaban (or similar drugs of the same category) before symptoms arise.
  9. Bleeding in other sites, including retroperitoneal, gastrointestinal, genitourinary or respiratory tract bleeding; superficial or skin surface bleeding mainly occurring in the vascular puncture site or transvenous approach (eg. arterial puncture, venous incision, etc. ) or in the recent surgical site.
  10. May be pregnant in the near future or already pregnant.
  11. Previously enrolled in this study.
  12. 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.

  13. Patients with an expected survival of less than 6 months.
  14. Patients with severe co-morbidity (including hepatic, renal, gastrointestinal, respiratory, cardiovascular, endocrine, immune and/or hematological disorders) which may affect the outcome assessment.
  15. Patients with mechanical heart valve. Biological valves are acceptable.
  16. 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.
  17. Investigators believe co-morbidities would be detrimental to the patient when the study begins.
  18. Patients difficult to follow up or with poor compliance due to various reasons (such as geographical and social factors, drug or alcohol abuse, etc.)
  19. Patient or his or her legal guardian/representative is unable or unwilling to give the written informed consent.
  20. Patients is in a condition that is not suitable for "puncture aspiration + urokinase" treatment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03957707
Other Study ID Numbers  ICMJE 2018-222
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Sponsor  ICMJE Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Second Affiliated Hospital, School of Medicine, Zhejiang University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP