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Minimally Invasive Soft Channel Brain Haemorrhage Evacuation for Acute Basal Ganglia Haemorrhage--Small Hemorrhage Evacuation (MIRACLE-S)

C

Capital Medical University

Status

Not yet enrolling

Conditions

Intracerebral Hemorrhage

Treatments

Other: Usual Care
Procedure: Minimally Invasive Soft Channel Brain Haemorrhage Evacuation (scMIS)

Study type

Interventional

Funder types

Other

Identifiers

NCT06688162
MIRACLE-S

Details and patient eligibility

About

The objective of this study is to determine whether minimally invasive soft channel brain hemorrhage evacuation (scMIS), compared to usual care, leads to superior functional recovery as measured by utility-weighted modified Rankin Scale (UW-mRS) scores at 6 months in patients with basal ganglia intracerebral hemorrhage (ICH) of 20 ≤ volume ≤ 30 ml.

Enrollment

750 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

  • Inclusion Criteria:

    1. Adults (18 - 80 years) ;
    2. The clinical diagnosis is acute intracerebral hemorrhage, confirmed by imaging;
    3. Onset within 48 hours, and surgery can be initiated within 48 hours;
    4. Basal ganglia hemorrhage, with a bleeding volume of 20 ≤ volume ≤ 30 ml;
    5. Reduced level of consciousness (GCS 9-14);
    6. Pre-stroke mRS score≤1 points;
    7. Systolic blood pressure <140 mmHg before randomisation;
    8. Informed consent obtain accordingly to local regulations.
  • Exclusion Criteria:

    1. 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 neurointerventional surgery.
    2. A high likelihood that the patient will not adhere to the study treatment and follow-up regimen.
    3. Platelet count < 100,000, INR > 1.4.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

750 participants in 2 patient groups, including a placebo group

Usual Care
Placebo Comparator group
Description:
Usual Care
Treatment:
Other: Usual Care
Minimally Invasive Soft Channel Brain Haemorrhage Evacuation (scMIS)
Experimental group
Description:
Minimally Invasive Soft Channel Brain Haemorrhage Evacuation(scMIS)
Treatment:
Procedure: Minimally Invasive Soft Channel Brain Haemorrhage Evacuation (scMIS)

Trial contacts and locations

0

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Central trial contact

HeTao Bian, PhD; XunMing Ji, PhD

Data sourced from clinicaltrials.gov

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