MIND: Artemis in the Removal of Intracerebral Hemorrhage

Más betegség

• Imaging
  • "Arterial Spot Sign" identified on final CTA indicating expanding hemorrhage
  • Hemorrhagic lesion such as a vascular malformation (cavernous malformation, AVM etc.), aneurysm, and/or neoplasm
  • Hemorrhagic conversion of an underlying ischemic stroke
  • Infratentorial hemorrhage
  • Primary thalamic ICH (where the center of the hemorrhage emulates from the thalamus)
  • Associated intra-ventricular hemorrhage requiring treatment for IVH-related mass effect or shift due to trapped ventricle (EVD for ICP management is allowed)
  • Midbrain extension/involvement
  • Absolute contraindication to CTA, conventional angiography and MRA

Laborértékek

• Coagulation Issues
  • Absolute requirement for long-term anti-coagulation (e.g., mechanical valve replacement (bio-prostatic valve is permitted), high risk atrial fibrillation)
  • Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
  • Platelet count < 100 x 10\^3 cells/mm3 or known platelet dysfunction
  • INR > 1.4, elevated prothrombin time or activated partial thromboplastin time (aPTT), which cannot be corrected or otherwise accounted for (i.e., lupus anti-coagulant)
  • Use of direct factor Xa inhibitors (e.g. apixaban, rivaroxaban, fondaparinux) within last 48 hours
• Patient Factors
  • Traumatic ICH
  • High risk atrial fibrillation (e.g., mitral stenosis with atrial fibrillation) and/or symptomatic carotid stenosis
  • Requirement for emergent surgical decompression or uncontrolled ICP after EVD
  • Unable to obtain consent per Institution Review Board/Ethics Committee policy
  • Pregnancy or positive pregnancy test (either serum or urine). Women of child-bearing potential must have a negative pregnancy test prior to enrollment
  • Severe active infection requiring treatment (e.g. sepsis or purulent wound) at the time of enrollment
  • Renal failure indicated by creatinine > 2 mg/dL or undergoing dialysis
  • Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 365 days
  • Based on investigator's judgement, patient is unwilling or unable to comply with protocol follow up appointment schedule
  • Active drug or alcohol use or dependence that, in the opinion of the site investigator would interfere with adherence to study requirements
  • Currently participating in another interventional (drug, device, etc) clinical trial. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible.

• Patient age ≥ 18 and ≤ 80
• Supratentorial ICH of volume ≥ 20 and ≤ 80 cc (measured using A x B X C/2 method)
• Hemostasis as confirmed by no arterial spot sign (may perform additional scan(s) every 6 hours to demonstrate hemostasis)
• NIHSS ≥ 6
• GCS ≥ 5 and ≤ 15
• Historical mRS 0 or 1
• Symptom onset < 24 hours prior to initial CT/MR
• MIS must be initiated within 72 hours of ictus/bleed
• SBP must be < 180 mmHg and controlled at this level for at least 6 hours