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

December 16, 2020 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. 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.
  2. 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 Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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.
  2. With dysfunctions such as hematoma-related motor aphasia, sensory aphasia, hemiplegic limb muscle strength ≤ grade 3 or NIHSS score ≥ 15.
  3. Hematoma volume increase <5 ml by ABC/2 formula shown by an additional CT scan after at least 6 hours of the diagnostic CT.
  4. Diagnostic CT scans 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 performed within 72 hours after onset.
  7. SBP <180 mmHg recorded for 6 hours prior to randomization.
  8. Age between 18-70 years old.
  9. mRS score ≤ 1 in past medical history.
  10. Patients are suitable and willing to be randomized to puncture aspiration plus rt-PA or conventional drug treatment.

Exclusion Criteria:

  1. Hematoma involves thalamus, midbrain and other structures.
  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, 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 unstable 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 in the vascular puncture sites or transvenous approaches (e.g. arterial puncture, venous incision, etc.), or the recent surgical sites.
  10. Patients who may be pregnant in the near future or are already pregnant.
  11. Patients previously enrolled in this study.
  12. 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.
  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 would 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. Patients with co-morbidities that would be detrimental if the study begins according to investigators.
  18. Lost to follow-up or 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 plus rt-PA treatment.

Early termination criteria:

  1. Serious adverse events related to minimally invasive treatment
  2. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Minimally invasive puncture aspiration plus rt-PA
Procedure: Minimally invasive puncture aspiration plus rt-PA
Stereotactic puncture aspiration to evacuate basal ganglion hematoma with use of thrombolytic agent
Active Comparator: Conservative medical treatment
Drug: Conservative medical treatment
Drugs for symptomatic treatment such as hemostasis and nerve nourishing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at 6 months of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hematoma clearance rate
Time Frame: at 1 day and 1 month after treatment
at 1 day and 1 month after treatment
Change in GCS score
Time Frame: at 1 month after treatment
GCS: Glasgow Coma Scale, ranges from 3-15, a higher GCS score means a better situation.
at 1 month after treatment
Mortality rate
Time Frame: at 6 months of follow-up
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
after 6 months of follow-up
Change in GCS score
Time Frame: at 6 months after treatment
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
Time Frame: at 6 months after treatment
at 6 months after treatment
All costs of the hospital stay
Time Frame: at 6 months after treatment
at 6 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

October 21, 2019

First Submitted That Met QC Criteria

November 19, 2019

First Posted (Actual)

November 21, 2019

Study Record Updates

Last Update Posted (Actual)

December 19, 2020

Last Update Submitted That Met QC Criteria

December 16, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-330

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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