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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

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.

Condition or disease Intervention/treatment Phase
Basal Ganglia Haematoma Procedure: stereotactic surgery plus thrombolysis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Sterotactic Operation Integrating With Thrombolysis in Basal Ganglion Hemorrhage Evacuation: a Randomized Controlled Trial.
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: stereotactic surgery with drugs treatment Procedure: stereotactic surgery plus thrombolysis
stereotactic puncture and aspiration to evacuate basal ganglion hematoma with or without thrombolytic agent

Sham Comparator: drugs treatment alone Procedure: stereotactic surgery plus thrombolysis
stereotactic puncture and aspiration to evacuate basal ganglion hematoma with or without thrombolytic agent




Primary Outcome Measures :
  1. The change of ADL score [ Time Frame: 6 months ]
  2. improvement of muscle strength of the hemiplegic limb or aphasia [ Time Frame: 6 months ]
  3. Changes in GOS score [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Mortality rate [ Time Frame: 6 months ]
  2. Hematoma clearance rate [ Time Frame: 1 day and one month ]
  3. Change in GCS score [ Time Frame: one month ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03957707


Locations
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China, Zhejiang
the Second Affiliated Hospital of Zhejiang University School of Medicine Recruiting
Hangzhou, Zhejiang, China, 310009
Contact: gao chen    8613805716226    d-gaochen@zju.edu.cn   
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University

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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT03957707     History of Changes
Other Study ID Numbers: 2018-222
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University:
basal ganglion hemorrhage
stereotactic surgery
thrombolysis

Additional relevant MeSH terms:
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Hemorrhage
Ganglion Cysts
Synovial Cyst
Hematoma
Basal Ganglia Hemorrhage
Pathologic Processes
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases
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