Health TrialsbyHealthPanel

Evacuation of Lobar Intracranial Hemorrhage Using Microsurgical Technique (ELIMINATE)

ConditionIntracerebral Hemorrhage Lobar
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDr. Michael D Hill

About this trial

ELIMINATE is a cohort study, phase 2A, designed to determine whether a standardized microsurgical procedure to evacuate spontaneous lobar intracranial hemorrhage (ICH) is feasible, safe and surgically efficacious in achieving a postoperative residual ICH volume \<15cc on 24-hour postoperative CT imaging.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• Adults > 18 years

CT evidence of acute, spontaneous lobar ICH defined as located <1cm from the cortical surface

ICH volume is >30cc but <80cc as measured by (length x width x height)/2

GCS 5-14 at presentation

Disqualifiers

• Underlying secondary etiology (AVM, tumor, etc. if known or identifiable acutely)

Intraventricular extension estimated to involve >50% of the lateral ventricle

Preoperative disability that will affect outcome as measured by modified Rankin Scale score (mRS>1 at baseline)

Individuals presenting with GCS <5 at presentation

Trial population

Adults with spontanous lobar ICH who are appropriate for surgical evacuation.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Microsurgical hematoma evacuation

    Procedure/Surgery

    Microsurgical hematoma evacuation using microscope and neuronavigation

Treatment groups

27 Participants
are divided into 1 treatment group
Group A: Single cohort deisgn1 intervention

Trial outcomes

Primary outcomes

1

Recruitment rate

Total recruitment will be recorded each month and report as number of patients recruited per calendar month as an average for duration of the study. The numerator will be the cumulative total number of pateints recruitment and the denominator will be the number of months elapsed since study start. The demoninator can be a fractional number; the numerator will also be a positive integer.

Time frame
Quarterly from study onset through study completion with the final recruitment rate recorded at the end of study; total time 12 months

Secondary outcomes

1

Residual hematoma volume

Residual hematoma volume

Time frame
Up to 2 days after enrolment; post-operative core lab assessment of the 18-54 hour follow-up CT brain scan. The Core Lab will measure residual hematoma volume using summative planimetry over the volume of each CT scan slice image.
2

modified Rankin Scale Score

mRS score is an integer scale ranging from 0 to 6 (7 point interval scale). Lower score are better and the highest score (6) implies death

Time frame
at 90 days and 180 days after enrolment.
3

EuroQoL

EQ5D-5L is a 5 domain scale, with a 5 point Likert scale for the quesiton in each domain. It addresses quality of life and the final score (the EQ5D Index) is adjusted by country to local norms using standardized methodology. Higher index scores inply a higher quality of life.

Time frame
at 90 days and 180 days after randomization

Other outcomes

1

Forceps forces

Intra-operative forceps forces during microsurgery. These devices have haptic measurement capability and will reocrd the degree of force each time dissection or cautery are used. Recording will be conducted during the entire operative procedure.

Time frame
Perioperative/peri-procedural

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dr. Michael D Hill

Lead sponsor

University of Calgary

Sponsor institution

University of Calgary

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: