Clinical trial NCT05891509: DTI-guided Minimally Invasive Hematoma Evacuation for Intracerebral Hemorrhage
Official title: Efficacy and Safety of DTI-guided Minimally Invasive Hematoma Evacuation Versus Best Medical Therapy for Acute Spontaneous Intracerebral Hemorrhage: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke Hemorrhagic
Keywords: Minimally Invasive Hematoma Evacuation
Intracerebral Hemorrhage
Randomized Controlled Trial
Magnetic Resonance Imaging
Lead sponsor: Xinqiao Hospital of Chongqing
Sponsor class: OTHER
Collaborators: name: Xingguo County People's Hospital
First posted: 2023-06-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Other design features: 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.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Proportion of score of 0-3 on the modified Rankin scale
timeFrame: 180 days after randomization
Secondary outcomes:
measure: Score of on the modified Rankin scale
timeFrame: 180 days after randomization
Other outcomes:
measure: Incidence of symptomatic intracranial hemorrhage
timeFrame: 30 days after randomization
Locations:
city: Ganzhou
country: China
facility: Xingguo County People's Hospital
state: Jiangxi
Study officials:
References: