EVACUATE-pilot - Ultra-Early, minimally inVAsive intraCerebral haemorrhage evacUATion versus standard trEatment (EVACUATE)-Pilot phase

Not Applicable

Completed

• Conditions: stroke; Stroke - Haemorrhagic

• Registration Number: ACTRN12619001748101
• Lead Sponsor: royal adelaide hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-10
• Study Completion: 2021-05-31
• Last Update Posted: 1 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of patients with a positive response defined as at least 50% of haematoma volume removal at 24 hour CT scan compared with baseline imaging, as measured by planimetry volumetric analysis. [24 hours post-surgical completion];Primary safety outcome - •The proportion of patients with significant haematoma reaccumulation at 24 hour follow-up CT scan (defined as either an increase in haematoma volume between post-operative and 24 hour scans of >100% and >10ml, or haematoma volume on the follow-up scan which exceeds admission volume)[24 hours post-surgical completion]

Secondary Outcome Measures

Name	Time	Method
Mean percentage haematoma removal at 24 hour CT scan [24 hours post-surgical completion];Mean percentage haematoma removal at post-operative CT scan [As soon as possible post-surgical completion];Percent of ICH subjects with < 15 cc clot (or >50% of initial volume) remaining on CT scan post endoscopic clot removal[As soon as possible post-surgical completion];Mean percentage haematoma removal at post-operative intracranial ultrasound (if performed)[As soon as possible post-surgical completion];Last known well time to commencement of procedure time (minutes, entered into study specific form)[Commencement of procedure];Procedure duration (in minutes, entered into study specific form)[End of procedure];Surgical complications (examination of medical records and surgeon self-report)[Discharge or 7 days (whichever is sooner)];Modified Rankin Score[3 and 6 months post-admission date];Mortality[3 and 6 months post-admission date]