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: Active, not recruiting
• Conditions: Basal Ganglia Haematoma
• Intervention / Treatment: Procedure: stereotactic surgery plus thrombolysis

• Study Type: Interventional
• Enrollment (Estimated): 380
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • The Second Affiliated Hospital of Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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 Assignment
• Masking: None (Open Label)

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
Favorable Functional Outcome as Defined by the modified Rankin Scale (mRS) Score	Functional independence is defined as achieving a score of 0, 1, or 2 on the mRS. The mRS is a 7-point scale that measures the degree of disability or dependence in the daily activities of patients who have had a stroke. The scale ranges from 0 (no symptoms) to 6 (dead).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hematoma clearance rate		1 day and one month
All-Cause Mortality		6 months
Change in Barthel Index (BI)	Functional status in activities of daily living (ADL) will be assessed using the Barthel Index (BI). The BI score ranges from 0 (completely dependent) to 100 (fully independent).	6 months
Changes in Glasgow Outcome Scale-Extended (GOS-E) score	The GOS-E is an 8-point scale that categorizes global outcomes from Dead (1) to Upper Good Recovery (8).	6 months
Total duration of the initial hospital stays		one month
Total direct medical costs during the index hospitalization		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; Xiaoshan Hospital; Ningbo No. 1 Hospital; Jinhua 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; Zhuji People's Hospital of Zhejiang Province; Huzhou Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): October 31, 2025

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 (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 27, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: thrombolysis; basal ganglion hemorrhage; stereotactic surgery
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Hemorrhage; Basal Ganglia Diseases; Intracranial Hemorrhages; Basal Ganglia Cerebrovascular Disease; Cerebral Hemorrhage; Pathological Conditions, Signs and Symptoms; Basal Ganglia Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Cardiovascular Agents; Hematologic Agents; Fibrinolytic Agents
• 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
• product manufactured in and exported from the U.S.: No