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New treatment option for Stroke Hemorrhagic
Official title DTI-guided Minimally Invasive Hematoma Evacuation for Intracerebral Hemorrhage
ClinicalTrials.gov ID: NCT05891509
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age 18-80 years old;
- Intracerebral hemorrhage in the basal ganglia was diagnosed by CT examination;
- The amount of bleeding is 20-40ml, and the midline structure is displaced horizontally by \< 3mm in the pineal gland;
- The degree of integrity and continuity of the corticospinal tract on the lesion side of magnetic resonance diffusion tensor imaging was graded as...
- The time from onset to randomization is within 24 hours;
You likely can't join if
- Bleeding in other parts (e.g., bleeding in subtentorial areas such as thalamus, brainstem or cerebellum);
- Bleeding caused by other causes (such as aneurysm, arteriovenous malformation, brain trauma, brain tumor, bleeding transformation of large cerebral...
- Multiple intracranial hemorrhage;
- Patients with ventricular hemorrhage or ICH rupture into the ventricles should consider the need for ventricular drainage;
- Any history of brain parenchymal or other intracranial subarachnoid, subdural or epidural hemorrhage and surgical history in the past 30 days;
- Myocardial infarction within the past 30 days;
See the full eligibility criteria
- Age 18-80 years old;
- Intracerebral hemorrhage in the basal ganglia was diagnosed by CT examination;
- The amount of bleeding is 20-40ml, and the midline structure is displaced horizontally by \< 3mm in the pineal gland;
- 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;
- The time from onset to randomization is within 24 hours;
- GCS score ≥ 4 points at randomization;
- Muscle strength level 3 in the affected limb;
- Written informed consent are provided by the patients or their legal representatives.
- Bleeding in other parts (e.g., bleeding in subtentorial areas such as thalamus, brainstem or cerebellum);
- 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...
- Multiple intracranial hemorrhage;
- Patients with ventricular hemorrhage or ICH rupture into the ventricles should consider the need for ventricular drainage;
- Any history of brain parenchymal or other intracranial subarachnoid, subdural or epidural hemorrhage and surgical history in the past 30 days;
- Myocardial infarction within the past 30 days;
- Previous history of bleeding, such as gastrointestinal bleeding, genitourinary bleeding, respiratory bleeding that has not been completely controlled;
- Hemoglobin \< 100g/L, hematocrit \<25%, platelet count \< 100\ 109/L;
- Receiving anticoagulant drugs such as warfarin, dabigatran or rivaroxaban within 1 week prior to enrollment, with an INR \> 1.4;
- Long-term anticoagulation and antiplatelet therapy are expected to be required;
- Allergy to alpeplase, urokinase or surgery-related drugs and instruments;
- Pregnant or lactating women;
- 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...
- hypertension (systolic blood pressure is still greater than 180mmHg) that cannot be effectively controlled by aggressive antihypertensive therapy before randomization;
- Life expectancy \< 12 months in the advanced stage of any disease;
- Participating in other treatment clinical studies.
The study team makes the final eligibility decision.
Where it's taking place
- Ganzhou, Jiangxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ganzhou, Jiangxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.