NCT01920763

Brief Summary

This pilot study will examine the safety and the clinical outcomes after minimally invasive surgery (using a parafascicular technique guided by diffusion-tensor imaging) for intracerebral hemorrhage in patients selected according to evidence-based criteria. The investigators will compare 30 day and 90 day outcomes of patients who have surgery to that predicted by previously reported models for recovery after ICH, and will also describe any surgical complications related to the procedure. The investigators hypothesize that this technique will have the same mortality rate and function outcome, if not better, when compared to the outcomes predicted by previous models.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2013

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 12, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

April 4, 2014

Status Verified

August 1, 2013

Enrollment Period

1 year

First QC Date

July 22, 2013

Last Update Submit

April 2, 2014

Conditions

Intracerebral Hemorrhage

Keywords

Intracerebral hemorrhageSurgical evacuationMinimally-invasive surgery

Outcome Measures

Primary Outcomes (8)

  • Change from Baseline NIHSS Score at 7 days

    Seven days after the procedure, patient NIHSS score(0-42 points)will be measured and compared to baseline (i.e. prior to surgery)as a measure of stroke severity.

    7 days

  • Change from Baseline Barthel index at 30 days

    Thirty days after the procedure, patient Barthel index (0-100 points)will be measured and compared to baseline (i.e. prior to surgery)as a measure of functional outcome. This assessment will be performed by telephone by an investigator not previously involved in their clinical care. This will be compared to predicted outcome as per modified ICH score.

    30 days

  • Change from Baseline Barthel Index at 7 days

    Seven days after the procedure, patient Barthel index(0-100 points)will be measured and compared to baseline (i.e. prior to surgery)as a measure of change in patient functional status.

    7 days

  • Change from Baseline modified Rankin Score at 7 days

    Seven days after the procedure, patient mRS score(0-6 points)will be measured and compared to baseline (i.e. prior to surgery)as a measure of functional outcome.

    7 days

  • Change from Baseline Modified Rankin Score at 30 days

    Thirty days after the procedure, patient mRS (0-6 points)will be measured and compared to baseline (i.e. prior to surgery)as a measure of functional outcome. This assessment will be performed by telephone by an investigator not previously involved in their clinical care. This will be compared to predicted outcome as per modified ICH score.

    30 days

  • Mortality at 30 days

    Thirty days after the procedure, patients will be contacted for assessment of Barthel index and modified Rankin scale measurement (see other thirty-day outcome measures). At that time, if the patient has died prior to telephone follow-up, the next of kin will be asked for the date and cause of death. This assessment will be performed by telephone by an investigator not previously involved in their clinical care. Mortality rate will be compared to predicted outcome as per modified ICH score.

    30 days

  • Change from Baseline Barthel index at 90 days

    Ninety days after the procedure, patient Barthel index (0-100 points)will be measured and compared to baseline (i.e. prior to surgery)as a measure of functional outcome. This assessment will be performed by telephone by an investigator not previously involved in their clinical care. This will be compared to predicted outcome as per essen ICH score.

    90 days

  • Change from Baseline Modified Rankin Score at 90 days

    Ninety days after the procedure, patient mRS (0-6 points)will be measured and compared to baseline (i.e. prior to surgery)as a measure of functional outcome. This assessment will be performed by telephone by an investigator not previously involved in their clinical care. This will be compared to predicted outcome as per Essen ICH score.

    90 days

Secondary Outcomes (1)

  • Presence of post-operative complications between surgery and 30 days

    30 days

Study Arms (1)

Surgical Patients

Patients with intracerebral hemorrhage who have been offered a parafascicular, minimally-invasive procedure for hematoma drainage, by the treating neurosurgeon.

Other: Clinical Measurement

Interventions

Clinical MeasurementOTHER

No direct interventions; study is observational and clinical assessments only will be performed.

Surgical Patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients aged 18-80 presenting with an acute non-traumatic symptomatic supratentorial primary ICH diagnosed by CT

You may qualify if:

  • Patients aged 18-80 presenting with an acute non-traumatic symptomatic supratentorial primary ICH diagnosed by CT
  • Severe neurological deficit (National Institutes of Health Stroke Scale (NIHSS) ≥6);
  • Symptom onset to surgery \< 24 hours (target \< 8 hours)
  • Glasgow Coma Score greater than or equal to 9
  • Hematoma volume \<50 millilitres
  • Minimal or no ventricular extension (corresponding to 50% or less of each ventricle)

You may not qualify if:

  • Suspected secondary or traumatic ICH
  • Infratentorial ICH
  • Isolated intraventricular hemorrhage (IVH)
  • Uncorrected coagulopathy
  • Significant premorbid disability (mRS \>1)
  • Hydrocephalus
  • Contraindication to safe surgical procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

Related Publications (2)

  • Nishihara T, Teraoka A, Morita A, Ueki K, Takai K, Kirino T. A transparent sheath for endoscopic surgery and its application in surgical evacuation of spontaneous intracerebral hematomas. Technical note. J Neurosurg. 2000 Jun;92(6):1053-5. doi: 10.3171/jns.2000.92.6.1053.

    PMID: 10839271BACKGROUND

  • McLaughlin N, Prevedello DM, Engh J, Kelly DF, Kassam AB. Endoneurosurgical resection of intraventricular and intraparenchymal lesions using the port technique. World Neurosurg. 2013 Feb;79(2 Suppl):S18.e1-8. doi: 10.1016/j.wneu.2012.02.022. Epub 2012 Feb 10.

    PMID: 22381841BACKGROUND

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2013

First Posted

August 12, 2013

Study Start

July 1, 2013

Primary Completion

July 1, 2014

Study Completion

October 1, 2014

Last Updated

April 4, 2014

Record last verified: 2013-08

Locations

CA(1)