Minimally invasive procedure for treating brain hemorrhage

Efficacy and Safety of DTI-guided Minimally Invasive Hematoma Evacuation Versus Best Medical Therapy for Acute Spontaneous Intracerebral Hemorrhage: a Randomized Controlled Trial

This study tests a new, less invasive procedure to see if it can help people with brain bleeding recover better than traditional methods.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Xinqiao Hospital of Chongqing (Academic / other)
• Locations: 1 site (Ganzhou, Jiangxi)
• Trial ID: NCT05891509 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of DTI-guided minimally invasive hematoma evacuation in patients with intracerebral hemorrhage (ICH). It involves a multicenter randomized controlled trial alongside a prospective observational study for patients who opt out of the trial. Participants will be monitored using standardized outcome measures, with a primary outcome assessed by a blinded evaluator. The study aims to clarify the role of this innovative approach in improving patient outcomes following ICH.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with specific criteria related to the location and severity of their intracerebral hemorrhage.

Not a fit: Patients with bleeding in areas other than the basal ganglia or those with hemorrhages caused by conditions like aneurysms or tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve recovery and reduce mortality in patients suffering from intracerebral hemorrhage.

How similar studies have performed: While the specific approach of DTI-guided evacuation is still being evaluated, similar minimally invasive techniques have shown promise in other studies.

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.

Where this trial is running

Ganzhou, Jiangxi

• Xingguo County People's Hospital — Ganzhou, Jiangxi, China (Recruiting)

Study contacts

• Study coordinator: Zhongming Qiu

Conditions Stroke Hemorrhagic; Minimally Invasive Hematoma Evacuation; Intracerebral Hemorrhage; Randomized Controlled Trial; Magnetic Resonance Imaging