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Ultra-Early, Minimally inVAsive intraCerebral Haemorrhage evacUATion Versus Standard trEatment

NCT04434807 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2025-10-28

No results posted yet for this study

Summary

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).

Conditions

  • Intra Cerebral Hemorrhage
  • Stroke

Interventions

PROCEDURE

Minimally invasive hematoma evacuation

Neurosurgery performed via burr hole or minicraniotomy and using the Aurora surgiscope and evacuator (Integra Lifesciences)

Sponsors & Collaborators

Principal Investigators

  • Timothy Kleinig · Royal Adelaide Hospital/University of Adelaide

  • Amal Abou-Hamden · Royal Adelaide Hospital/University of Adelaide

  • John Laidlaw · Royal Melbourne Hospital/University of Melbourne

  • J Mocco · Icahn School of Medicine, Mt Sinai Hospital, New York

  • Christopher Kellner · Icahn School of Medicine, Mt Sinai Hospital, New York

  • Stephen Davis · Royal Melbourne Hospital/University of Melbourne

  • Bruce Campbell · Royal Melbourne Hospital/University of Melbourne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-15
Primary Completion
2027-12-31
Completion
2028-12-31
FDA Device
Yes

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04434807 on ClinicalTrials.gov