Minimally invasive procedure for treating brain hemorrhage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Zhongming Qiu
• Email: qiuzhongmingdoctor@163.com
• Phone: +8613236599269

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Wireless NIRS Sensor Use in the NICU for Monitoring on Neonates

  A wireless NIRS sensor is tested on infants in the NICU to see how well it stays on and how it notes brain signals when used alongside standard wired sensors.

  Recruiting McGill University Health Centre/Research Institute of the McGill University Health Centre · Montreal, Quebec · NCT07732244

• Virtual Stroke Unit care for patients in non-specialized hospitals

  This study tests whether delivering stroke care remotely via a Virtual Stroke Unit is as safe and effective as traditional stroke units for adults with acute stroke who aren’t candidates for thrombectomy.

  Recruiting Hospital Universitario Virgen Macarena · Seville · NCT07635498

• Rapid removal of deep brain clots with minimally invasive surgery

  This trial will test whether early minimally invasive surgery to remove deep brain clots helps adults (18–70) with spontaneous basal ganglia hemorrhage compared with usual medical care.

  Recruiting at 17 sites Emory University · Birmingham, Alabama and 23 other locations · NCT06870812

• Emergency Stroke Unit for treating acute strokes

  This study is testing a new Emergency Stroke Unit that uses a mobile MRI to see if it can help treat stroke patients faster and improve their recovery.

  Recruiting Chinese University of Hong Kong · Hong Kong · NCT06728592

• Comparing reactive balance training with and without electrical stimulation for stroke recovery

  This study is testing whether adding electrical stimulation to balance training can help people who have had a stroke improve their balance better than training without it.

  Recruiting University of Illinois Chicago · Chicago, Illinois · NCT06127602

• Using the Atalante exoskeleton to help stroke patients walk again

  This study is testing if using the Atalante exoskeleton can help stroke patients walk better compared to regular therapy.

  Recruiting at 4 sites Wandercraft · Créteil and 4 other locations · NCT06107010

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.