DTI-guided Minimally Invasive Hematoma Evacuation for Intracerebral Hemorrhage

NCT ID: NCT05891509

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-03
• Study Completion Date: 2027-08-31

Brief Summary

Intracerebral hemorrhage (ICH) is a devastating disease with high early mortality, unfavorable neurological outcomes, and high cost of care. To date, the role of DTI-guided minimally invasive hematoma evacuation in ICH is still uncertain.

The investigators will conduct a multicenter randomized controlled trial, as well as a concurrent prospective observational study including all ICH patients who decline participation in the trial and will therefore receive minimally invasive hematoma evacuation or best medical therapy and consent to be followed up. All participants will be followed up at the same time using the same outcomes measures. The primary outcome will be collected by a blinded assessor.

Conditions

Stroke Hemorrhagic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Minimally Invasive Hematoma Evacuation

Subjects randomized to this arm will receive the intervention of minimally invasive hematoma evacuation and best medical therapy

Group Type: EXPERIMENTAL

Minimally Invasive Hematoma Evacuation

Intervention Type: PROCEDURE

Procedure of minimally invasive hematoma evacuation PLUS best medical therapy

Best Medical Therapy

Intervention Type: OTHER

Best medical therapy

Best Medical Therapy

Subjects randomized to this arm will receive best medical therapy alone

Group Type: ACTIVE_COMPARATOR

Best Medical Therapy

Intervention Type: OTHER

Best medical therapy

Interventions

Minimally Invasive Hematoma Evacuation

Procedure of minimally invasive hematoma evacuation PLUS best medical therapy

Intervention Type: PROCEDURE

Best Medical Therapy

Best medical therapy

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age 18-80 years old;

2. Intracerebral hemorrhage in the basal ganglia was diagnosed by CT examination;

3. The amount of bleeding is 20-40ml, and the midline structure is displaced horizontally by < 3mm in the pineal gland;

4. The degree of integrity and continuity of the corticospinal tract on the lesion side of magnetic resonance diffusion tensor imaging was graded as grade 2~4;

5. The time from onset to randomization is within 24 hours;

6. GCS score ≥ 4 points at randomization;

7. Muscle strength level 3 in the affected limb;

8. Written informed consent are provided by the patients or their legal representatives.

Exclusion Criteria

1. Bleeding in other parts (e.g., bleeding in subtentorial areas such as thalamus, brainstem or cerebellum);

2. Bleeding caused by other causes (such as aneurysm, arteriovenous malformation, brain trauma, brain tumor, bleeding transformation of large cerebral infarction, bleeding caused by β amyloidosis, bleeding caused by coagulation dysfunction) or combined with aneurysm, arteriovenous malformation, brain trauma, brain tumor, large-scale cerebral infarction, β amyloidosis, severe coagulation dysfunction;

3. Multiple intracranial hemorrhage;

4. Patients with ventricular hemorrhage or ICH rupture into the ventricles should consider the need for ventricular drainage;

5. Any history of brain parenchymal or other intracranial subarachnoid, subdural or epidural hemorrhage and surgical history in the past 30 days;

6. Myocardial infarction within the past 30 days;

7. Previous history of bleeding, such as gastrointestinal bleeding, genitourinary bleeding, respiratory bleeding that has not been completely controlled;

8. Hemoglobin < 100g/L, hematocrit <25%, platelet count < 100*109/L;

9. Receiving anticoagulant drugs such as warfarin, dabigatran or rivaroxaban within 1 week prior to enrollment, with an INR > 1.4;

10. Long-term anticoagulation and antiplatelet therapy are expected to be required;

11. Allergy to alpeplase, urokinase or surgery-related drugs and instruments;

12. Pregnant or lactating women;

13. Known high risk of embolism, including patients with mechanical heart valves implanted in the body, history of left heart thrombosis, mitral stenosis with atrial fibrillation, acute pericarditis, or subacute bacterial endocarditis. Atrial fibrillation without mitral stenosis is appropriate;

14. hypertension (systolic blood pressure is still greater than 180mmHg) that cannot be effectively controlled by aggressive antihypertensive therapy before randomization;

15. Life expectancy < 12 months in the advanced stage of any disease;

16. Participating in other interventional clinical studies.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xingguo County People's Hospital

UNKNOWN

Sponsor Role: collaborator

Zhongming Qiu

OTHER

Sponsor Role: lead

Responsible Party

Zhongming Qiu

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Xingguo County People's Hospital

Ganzhou, Jiangxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhongming Qiu

Role: CONTACT

qiuzhongmingdoctor@163.com

+8613236599269

Facility Contacts

Guangui Yang, MS

Role: primary

Other Identifiers

GLAMOR

Identifier Type: -

Identifier Source: org_study_id