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

Sterotactic Operation Integrating With Thrombolysis in Basal Ganglion Hemorrhage Evacuation: a Randomized Controlled Trial.

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.

Study Overview

• Status: Recruiting
• Conditions: Basal Ganglia Haematoma
• Intervention / Treatment: Procedure: stereotactic surgery plus thrombolysis

• Study Type: Interventional
• Enrollment (Anticipated): 360
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • The Second Affiliated Hospital of Zhejiang University School of Medicine
      • Contact: gao chen; Phone Number: 8613805716226; Email: d-gaochen@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 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 < 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of ADL score	ADL: Activities of Daily Living, ranges from 0-100, a higher ADL score means a better situation.	6 months
improvement of muscle strength of the hemiplegic limb or aphasia		6 months
Changes in GOS score	GOS: Glasgow Outcome Scale, ranges from 1-5, a higher GOS score means a better situation.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality rate		6 months
Hematoma clearance rate		1 day and one month
Change in GCS score	GCS: Glasgow Coma Scale, ranges from 3-15, a higher GCS score means a better situation.	one month

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Ningbo Medical Center Lihuili Hospital; Second Affiliated Hospital of Wenzhou Medical University; Sir Run Run Shaw Hospital; Ningbo No. 1 Hospital; Jinhua Central Hospital; Huizhou Municipal Central Hospital; Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University; The Second Affiliated Hospital of Jiaxing University; People's Hospital of Quzhou; The Sixth Affiliated Hospital of Wenzhou Medical University; Affiliated Wenling Hospital of Wenzhou Medical University; Affiliated Zhuji Hospital of Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: May 19, 2019
• First Submitted That Met QC Criteria: May 19, 2019
• First Posted (ACTUAL): May 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 17, 2021
• Last Update Submitted That Met QC Criteria: November 16, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: thrombolysis; basal ganglion hemorrhage; stereotactic surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Cysts; Connective Tissue Diseases; Basal Ganglia Diseases; Mucinoses; Intracranial Hemorrhages; Basal Ganglia Cerebrovascular Disease; Cerebral Hemorrhage; Hemorrhage; Ganglion Cysts; Synovial Cyst; Hematoma; Basal Ganglia Hemorrhage
• Other Study ID Numbers: 2018-222

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No