Brain surgery to drain bleeding in the brain compared with medicine alone
Tests a minimally invasive drainage procedure against standard medicine in adults with brain bleeding.
Key facts
- Who runs it
- Zhongming Qiu
- Where
- Ganzhou, ChinaSee the site
- Trial code
- Registry title
- DTI-guided Minimally Invasive Hematoma Evacuation for Intracerebral Hemorrhage
- Status
- Recruiting
- People taking part
- 100 people, planned
- Started
- 3 Aug 2023
- Expected to end
- 31 Aug 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Minimally Invasive Hematoma Evacuation
- Best Medical Therapy
- Record updated
- 13 September 2023
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18-80 with a bleed in the basal ganglia of the brain, 20-40ml in size, who can be randomized within 24 hours of onset.
- Age
- 18-80 years
- Sex
- All sexes can join.
- Disease stage
- Intracerebral hemorrhage in the basal ganglia seen on CT. Bleeding of 20-40ml. Midline structure shifted by less than 3mm. Corticospinal tract grade 2~4 on MRI diffusion tensor imaging. Within 24 hours of onset. GCS score of 4 or more. Muscle strength level 3 in the affected limb.
- Earlier treatment
- No anticoagulant drugs such as warfarin, dabigatran or rivaroxaban within 1 week before enrollment, with an INR above 1.4. Long-term anticoagulant or antiplatelet treatment must not be expected to be needed. No brain bleed or brain surgery in the past 30 days.
Main reasons for not taking part
- Bleeding in other parts of the brain, such as thalamus, brainstem or cerebellum
- Bleeding caused by other causes, such as aneurysm, tumor or head injury
- Bleeding into the ventricles, or multiple brain bleeds
- Heart attack within the past 30 days
- Pregnant or breastfeeding women
The registry criteria, word for word
Show all 24 criteriaShow less
Who can take part
- 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
Who cannot take part
- Previous history of bleeding, such as gastrointestinal bleeding, genitourinary bleeding, respiratory bleeding that has not been completely controlled
- Long-term anticoagulation and antiplatelet therapy are expected to be required
- 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 coagulation dysfunction) or combined with aneurysm, arteriovenous malformation, brain trauma, brain tumor, large-scale cerebral infarction, β amyloidosis, severe coagulation dysfunction
- 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
- Allergy to alpeplase, urokinase or surgery-related drugs and instruments
- 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
- 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
- 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
- Pregnant or lactating women
- Participating in other interventional clinical studies
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in China
- Xingguo County People's HospitalGanzhou, ChinaContact: Guangui Yang, MSTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Minimally Invasive Hematoma EvacuationTreatment being tested
Subjects randomized to this arm will receive the intervention of minimally invasive hematoma evacuation and best medical therapy
Treatment: Minimally Invasive Hematoma Evacuation and Best Medical Therapy
- Best Medical TherapyExisting treatment, for comparison
Subjects randomized to this arm will receive best medical therapy alone
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Brain surgery to drain bleeding in the brain compared with medicine aloneGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05891509, who can take part
- Record updated
- 13 September 2023