NCT04434807Recruiting
Ultra-Early, Minimally inVAsive intraCerebral Haemorrhage evacUATion Versus Standard trEatment
Ultra-Early, Minimally inVAsive intraCerebral Haemorrhage evacUATion Versus Standard trEatment (EVACUATE)
Source: ClinicalTrials.gov · Last updated 28 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
A randomized controlled trial of ultra-early, minimally invasive, hematoma evacuation versus standard care within 8 hours of intracerebral hemorrhage. Patients presenting to the emergency department with stroke due to supratentorial, spontaneous intracerebral hemorrhage \>20mL volume will be assessed to determine their eligibility for randomization into the trial. If the patient gives informed consent they will be randomized 50:50 using central computerized allocation to minimally invasive hematoma evacuation using the Aurora surgiscope and evacuator (Integra Lifesciences) versus standard medical therapy. The trial is prospective, randomized, open-label, blinded endpoint (PROBE) design with seamless phase 2b-3 transition if the intermediate endpoint (successful hematoma evacuation) is met in analysis of the first 52 patients. Adaptive sample size re-estimation (Mehta and Pocock) will be performed when 160 patients have completed 6 month follow-up (minimum sample size 240, maximum sample size 434).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- First submitted
- 13 Jun 2020
- Start date
- 15 Nov 2020
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- University of Melbourne
- Diseases
- Stroke
- NCT number
- NCT04434807
What you commit to
- Study type: Interventional
- Planned participants: 240
- From 15 Nov 2020 to the primary completion date, 31 Dec 2027
- 13 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent (\<1 hour) thrombolysis. If the ICH has occurred between 1 and 12 hours following thrombolysis, cryoprecipitate (1U per 10kg) and tranexamic acid must be administered prior to treatment.
Other illness
- Known terminal illness such that the patients would not be expected to survive a year.
- 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.
Lab values
- Hereditary or acquired hemorrhagic diathesis or coagulation factor deficiency (in liver disease, INR\>1.4).
- Platelet count \<75,000
- Unreversible heparinization or anticoagulation. If reversing warfarin, INR should be ≤1.4 before procedure commences. 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.
Other
- Brainstem ICH
- 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.
- Recent (\<12 hours) parenteral GPIIb/IIIa antagonist.
- Participation in any investigational study in the last 30 days
- Pregnant women (clinically evident)
- Co-morbidities or advance care directive preventing general anaesthesia for the procedure.
- Planned withdrawal of care or comfort care measures.
Who the study is looking for
- Patients with an acute supratentorial intracerebral hemorrhage (ICH) ≥20mL in volume
- Age ≥18 years
- Surgery can commence within 8 hours of symptom onset (the time the patient was last known to be well) or, in patients with wake-up onset, within 8 hours of the time the patient awoke with symptoms. Patients presenting with small ICH (volume \<20mL) with clinical deterioration judged due to ICH hematoma expansion meeting volume criteria may be randomized if surgery can commence within 8 hours of clinical deterioration
- Moderate neurological deficit (NIHSS≥6)
- Pre-stroke mRS ≤3 (independent function or requiring only minor domestic assistance and able to manage alone for at least 1 week).
- CTA or MRA is performed and does not show an underlying vascular lesion
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Royal Adelaide Hospital Coordinator of this site? Confirm its status | Adelaide | Australia | Recruiting |
| Princess Alexandra Hospital Coordinator of this site? Confirm its status | Brisbane | Australia | Not yet recruiting |
| The Royal Brisbane and Women's Hospital Coordinator of this site? Confirm its status | Brisbane | Australia | Recruiting |
| The Alfred Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| The Austin Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Not yet recruiting |
| Monash Medical Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Not yet recruiting |
| John Hunter Hospital Coordinator of this site? Confirm its status | Newcastle | Australia | Recruiting |
| The Royal Melbourne Hospital Coordinator of this site? Confirm its status | Parkville | Australia | Recruiting |
| Gold Coast University Hospital Coordinator of this site? Confirm its status | Southport | Australia | Recruiting |
| Liverpool Hospital Coordinator of this site? Confirm its status | Sydney | Australia | Recruiting |
| Westmead Hospital Coordinator of this site? Confirm its status | Sydney | Australia | Not yet recruiting |
| Royal Prince Alfred Hospital Coordinator of this site? Confirm its status | Sydney | Australia | Not yet recruiting |
| Prince of Wales Hospital Coordinator of this site? Confirm its status | Sydney | Australia | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.