BridgeMD
New treatment option for Basal Ganglia Intracerebral Hemorrhage
Official title Minimally Invasive Neuroendoscopic Ultra-Early Targeted ICH Evacuation
ClinicalTrials.gov ID: NCT07260916
What this study is testing
- What it's testing
- MINUTE is a prospective, multi-center, randomized, controlled, blinded assessor, adaptive enrichment design, clinical trial. Eligible patients with spontaneous BGH ≥20 mL will be randomized 1:1 to either minimally invasive endoscopic SCUBA evacuation plus standard medical management or standard medical management alone; the time of randomization will be used to classify participants in one of two cohorts: 1) those randomized \<8 hours from onset, and 2) those randomized 8-16 hours from onset.
- 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 and ≤ 80 years
- Non-traumatic, spontaneous, supratentorial, non-thalamic, BGH of volume ≥ 20 mL, as determined by the treating physician using ABC/2 method
- NIHSS ≥ 6 at presentation
- Computed Tomography Angiography (CTA) or Magnetic Resonance Angiography (MRA) is performed and does not show an underlying vascular lesion
- Pre-ICH mRS 0-2 Informed consent from patient or legally authorized representative (LAR) to participate in the trial, wherein patient/LAR's stated...
You likely can't join if
- Suspected secondary cause for the ICH, such as an underlying vascular malformation (cavernous malformation, arteriovenous malformation, etc.)...
- Midbrain extension/involvement
- Coagulopathy defined as international normalized ratio (INR) \> 1.4
- Elevated activated Partial Thromboplastin Time (aPTT) \> 40 s
- Concurrent use of direct oral anticoagulants or low molecular weight heparin at ICH onset
- Known hereditary or acquired hemorrhagic diathesis or coagulation factor deficiency
See the full eligibility criteria
- Age ≥ 18 and ≤ 80 years
- Non-traumatic, spontaneous, supratentorial, non-thalamic, BGH of volume ≥ 20 mL, as determined by the treating physician using ABC/2 method
- NIHSS ≥ 6 at presentation
- Computed Tomography Angiography (CTA) or Magnetic Resonance Angiography (MRA) is performed and does not show an underlying vascular lesion
- Pre-ICH mRS 0-2 Informed consent from patient or legally authorized representative (LAR) to participate in the trial, wherein patient/LAR's stated wishes are to pursue lifesaving therapies as opposed to early withdrawal...
- The treating physician anticipates that surgery can be initiated \<120 min from randomization
- Randomization can occur ≤16 hours from LKW
- Suspected secondary cause for the ICH, such as an underlying vascular malformation (cavernous malformation, arteriovenous malformation, etc.), aneurysm, neoplasm, hemorrhagic transformation of an underlying ischemic...
- Midbrain extension/involvement
- Coagulopathy defined as international normalized ratio (INR) \> 1.4
- Elevated activated Partial Thromboplastin Time (aPTT) \> 40 s
- Concurrent use of direct oral anticoagulants or low molecular weight heparin at ICH onset
- Known hereditary or acquired hemorrhagic diathesis or coagulation factor deficiency
- Platelet count \<100 x 103 cells/mm3, or known platelet dysfunction (reversal of coagulopathy is not allowed) GCS score \<7 at presentation
- Evidence of active infection indicated by fever ≥100.7 °F and/or open draining wound at the time of enrollment
- Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 365 days
- Intraventricular extension of the hemorrhage is visually estimated to involve \> 50% of either of the lateral ventricles
- Pregnancy (women of childbearing potential must have a negative pregnancy test to participate)
- Based on investigator's judgment, the patient does not have the necessary mental capacity to participate or is unwilling to comply with the protocol follow-up schedule
- Current participation in another treatment (drug or device) trial
- Pre-existing Do Not Resuscitate (DNR)/Do Not Intubate (DNI) status
- History of severe dementia
The study team makes the final eligibility decision.
Where it's taking place
- New Brunswick, New Jersey, United States
- New York, New York, United States
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 New Brunswick, New Jersey, United States; New York, New York, United States. 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.