Sterotactic Operation Integrating With Thrombolysis in Basal Ganglion Hemorrhage Evacuation

NCT03957707 | Active Not Recruiting DMC

• 1 other identifier: 2018-222
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

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.

Conditions

Basal Ganglia Haematoma

Keywords

basal ganglion hemorrhage; stereotactic surgery; thrombolysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• All-Cause Mortality

  6 months

• Change in Barthel Index (BI)

  6 months

• Changes in Glasgow Outcome Scale-Extended (GOS-E) score

  6 months

• Hematoma clearance rate

  1 day and one month

• Total duration of the initial hospital stays

  one month

Study Arms (2)

stereotactic surgery with drugs treatment

EXPERIMENTAL

Procedure: stereotactic surgery plus thrombolysis

drugs treatment alone

SHAM COMPARATOR

Procedure: stereotactic surgery plus thrombolysis

Interventions

stereotactic surgery plus thrombolysis PROCEDURE

stereotactic puncture and aspiration to evacuate basal ganglion hematoma with or without thrombolytic agent

drugs treatment alone; stereotactic surgery with drugs treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Hematoma involves other structures such as the thalamus and midbrain.
• Mass effect or hydrocephalus due to intraventricular hemorrhage.
• 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.
• Manifestation of early stage cerebral herniation such as ipsilateral pupil changes and midline shift exceeding 1 cm.
• Patients with unsteady hematoma or with progression to intracranial hypertension syndrome.
• Patients with any irreversible coagulopathy or known coagulation disorders; platelet count \<100,000; INR \> 1.4.
• Patients requiring long-term use of anticoagulants.
• Patients taking dabigatran, apixaban and/or rivaroxaban (or similar drugs of the same category) before symptoms arise.
• 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.
• May be pregnant in the near future or already pregnant.
• Previously enrolled in this study.
• 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.
• Patients with an expected survival of less than 6 months.
• Patients with severe co-morbidity (including hepatic, renal, gastrointestinal, respiratory, cardiovascular, endocrine, immune and/or hematological disorders) which may affect the outcome assessment.

Sponsors & Collaborators

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

Study Sites (1)

the Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Basal Ganglia Hemorrhage

Interventions

Fibrinolytic Agents

Condition Hierarchy (Ancestors)

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; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Cardiovascular Agents; Therapeutic Uses; Hematologic Agents

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2019
• First Posted: May 21, 2019
• Study Start: January 1, 2019
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

CN (1)