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New treatment option for Intracerebral Hemorrhage
Official title Minimally Invasive Soft Channel Brain Haemorrhage Evacuation for Acute Basal Ganglia Haemorrhage-- Large Hemorrhage Evacuation (MIRACLE-L)
ClinicalTrials.gov ID: NCT06688201
What this study is testing
- What it's testing
- To determine if minimally invasive soft channel brain hemorrhage evacuation (scMIS), compared with any other neurosurgical technique that includes open craniotomy, small skull window microsurgery , and endoscopic surgery, is at least as effective ('not inferior') on poor clinical outcome of death or major disability (mRS scores 4-6) at 6 months in basal ganglia intracerebral hemorrhage (ICH) of 30 \< volume ≤ 100 ml.
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
- 1. Adults (18 - 80 years) ;
- The clinical diagnosis is acute intracerebral hemorrhage, confirmed by imaging;
- Onset within 48 hours, and surgery can be initiated within 48 hours;
- Basal ganglia hemorrhage, with a bleeding volume of 30 \< volume ≤ 100 ml;
- Reduced level of consciousness (GCS 4-14);
You likely can't join if
- Definite evidence the ICH is secondary to a structural abnormality in the brain (eg arteriovenous malformation, intracranial aneurysm, tumour...
- A high likelihood that the patient will not adhere to the study treatment and follow-up regimen.
- Platelet count \ 1.4.
See the full eligibility criteria
- 1. Adults (18 - 80 years) ;
- The clinical diagnosis is acute intracerebral hemorrhage, confirmed by imaging;
- Onset within 48 hours, and surgery can be initiated within 48 hours;
- Basal ganglia hemorrhage, with a bleeding volume of 30 \< volume ≤ 100 ml;
- Reduced level of consciousness (GCS 4-14);
- Pre-stroke mRS score≤1 points;
- Systolic blood pressure \<140 mmHg before randomisation;
- Availability of being able to receive either scMIS or other neurosurgical technique;
- Informed consent obtain accordingly to local regulations.
- Definite evidence the ICH is secondary to a structural abnormality in the brain (eg arteriovenous malformation, intracranial aneurysm, tumour, trauma, cerebral venous thrombosis) or previous thrombolysis or...
- A high likelihood that the patient will not adhere to the study treatment and follow-up regimen.
- Platelet count \ 1.4.
The study team makes the final eligibility decision.
Where it's taking place
- Linyi, Shandong, 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 Linyi, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
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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.