Tenecteplase (TNK) in the Treatment of Intracerebral Hemorrhage (ICH)

Korábbi kezelés

• An unknown time of onset or the symptoms onset more than 24 hours prior to admission.
• Sustained SBP >180 mm Hg for six hours recorded closest to the time of drug administration.
• Use of anticoagulants prior to symptom onset and subjects requiring long-term anticoagulants (the reversal is permitted if the patient can tolerate the short-term risk of reversal).
• Use of Dabigatran, Apixaban, and/or Rivaroxaban (or a similar medication from the similar medication class) prior to symptom onset.
• Participation in a concurrent clinical trial.
• The patient is unstable and would not benefit from a surgical intervention.

Más betegség

• Presence of infratentorial parenchymal bleeding.
• Presence of a hemorrhage extending to the midbrain.
• Radiological evidence of arterio-venous malformation, aneurysm, amyloid angiopathy, Moyamoya disease, hemorrhagic conversion of an ischemic stroke, recurrent hemorrhage in the same location within the past 365 year or unstable mass as a source for the ICH.
• Internal bleeding (GI, renal, respiratory etc).
• Mechanical heart valve (Bioprosthetic heart valve is permitted).
• Known risk for embolization, including history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis, or subacute bacterial endocarditis (atrial fibrillation without mitral stenosis is permitted).
• Allergy or sensitivity to TNKase.
• Serious illness (advanced stage which can interfere with the outcome).
• Symptomatic tract hemorrhage or a tract hemorrhage more than 5 mm.

Laborértékek

• Evidence of coagulopathy (international normalized ratio >1.3; platelet count <100 ,000 or platelet dysfunction P2Y-12 >250) or known clotting disorder.
• Inability to maintain INR less than 1.3.

Életkor

• Age <18 and >80 years.

Egyéb

• Pregnancy.
• Inability to obtain written informed consent from subject or legal representative.
• Bilateral fixed, dilated pupils indicating irreversible impaired brain stem function with GCS ≤4.
• Patients with severe ICH and IVH who require an external ventricular drain (EVD) placement for cerebrospinal fluid (CSF) diversion or separate intraventricular thrombolysis.
• GCS score of 3-4 and 15 (to ensure patient safety and study feasibility).
• Historical mRS score of 2-6 (at admission).

• Patient/legally authorized representative has signed the Informed Consent Form.
• Ability to comply with the study protocol, in the investigator's judgment.
• Patients 18 to 80 years of age with an ICH had occurred within 24 hours before admission.
• Spontaneous supratentorial (basal ganglia, thalamus, lobar) ICH ≥30 mL measured utilizing the ABC/2 method.
• Subjects with a GCS score of 5-14.
• NIHSS ≥6.
• Stability CT scan done at least 6 hours after baseline CT showing clot stability (growth <5 mL as measured by ABC/2 method). If the hematoma volume measured on the stability CT scan increases by 5 mL or more, a second stability CT scan will be performed 12 hours later.
• Sustained systolic blood pressure (SBP) <180 mm Hg for six hours recorded closest to the time of drug administration.
• Symptoms must be present less than 24 hours prior to baseline CT scan.
• Baseline Rankin score of 0 or 1.