ltra-Early, minimally inVAsive intraCerebral haemorrhage evacUATion versus standard trEatment (EVACUATE)-Pilot phaseA phase IIa pilot feasibility study of ultra-early minimally invasive haematoma evacuation within 12 hours of intracerebral haemorrhage

royal adelaide hospital0 个研究点目标入组 14 人开始时间: 2019年12月10日最近更新: 2021年11月1日

适应症

试验速览

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•1.Patients presenting with an acute spontaneous supratentorial ICH >=20mL in volume
•2.Age greater than or equal to 18 years
•3.Surgery can commence within 12 hours of symptom onset (or in patients with unknown time of symptom onset, the time patient was last known to be well) OR in patients presenting with small ICH (volume <20mL) with clinical deterioration judged due to ICH haematoma expansion meeting volume criteria, within 12 hours of clinical deterioration
•4.Moderate to severe neurological deficit (NIHSSgreater than or equal to 6)
•5.CTA or MRA is performed and does not show an underlying vascular lesion

•1.Glasgow coma scale (GCS) of 3 unless procedure can be commenced within 1 hour of deterioration to this level
•2.Brainstem ICH (minimal brainstem extension of a thalamic ICH is allowed)
•3.ICH secondary to trauma, where brain injury is judged more likely to be due to the broad effects of trauma rather than the focal ICH,
•4.Hereditary or acquired haemorrhagic diathesis or coagulation factor deficiency (in liver diease, INR>1.5).
•5.Platelet count <75,000
•6.Unreversed heparinization or anticoagulation. An INR or less than 1.6 is required in the setting of reversed warfarinisation. Reversal of heparin by protamine, dabigatran by idarucizumab and rivaroxaban, apixaban and enoxaparin by andexanet (where available) is permitted. Unreversed anticoagulation with a last dose within 48 hours is an exclusion.
•7.Recent (<12 hours) parenteral GPIIb/IIIa antagonist.
•8.Recent (<1 hour) thrombolysis. If the ICH has occurred between 1 and 12 hours following thrombolysis cryoprecipitate (1U per 10kg) must be administered prior to treatment.
•9.Participation in any investigational study in the last 30 days
•10.Known terminal illness such that the patients would not be expected to survive a year.
•11.Planned withdrawal of care or comfort care measures.
•12.Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.

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