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Observational Study of Safety and Outcomes After Minimally Invasive Surgery for Intracerebral Hemorrhage (MiSPACE)

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ClinicalTrials.gov Identifier: NCT01920763
Recruitment Status : Withdrawn (Lack of recruitment.)
First Posted : August 12, 2013
Last Update Posted : April 4, 2014
Sponsor:
Collaborator:
The Ottawa Hospital
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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.


Condition or disease Intervention/treatment
Intracerebral Hemorrhage Other: Clinical Measurement

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Outcomes Following Parafascicular Surgical Evaluation of Intracerebral Hemorrhage: A Pilot Study
Study Start Date : July 2013
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Group/Cohort Intervention/treatment
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
No direct interventions; study is observational and clinical assessments only will be performed.




Primary Outcome Measures :
  1. Change from Baseline NIHSS Score at 7 days [ Time Frame: 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.

  2. Change from Baseline Barthel index at 30 days [ Time Frame: 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.


  3. Change from Baseline Barthel Index at 7 days [ Time Frame: 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.

  4. Change from Baseline modified Rankin Score at 7 days [ Time Frame: 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.

  5. Change from Baseline Modified Rankin Score at 30 days [ Time Frame: 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.


  6. Mortality at 30 days [ Time Frame: 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.


  7. Change from Baseline Barthel index at 90 days [ Time Frame: 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.


  8. Change from Baseline Modified Rankin Score at 90 days [ Time Frame: 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.



Secondary Outcome Measures :
  1. Presence of post-operative complications between surgery and 30 days [ Time Frame: 30 days ]
    We will collect data on any surgical complications, defined as peri-operative blood loss, thrombotic events, infections, neurological worsening, seizures, metabolic disturbances, and cardiopulmonary events, within 30 days of surgery. We will include data from re-admissions within the first 30 days.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients aged 18-80 presenting with an acute non-traumatic symptomatic supratentorial primary ICH diagnosed by CT
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920763


Locations
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Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9
Sponsors and Collaborators
Ottawa Hospital Research Institute
The Ottawa Hospital

Publications:
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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01920763     History of Changes
Other Study ID Numbers: MiSPACECan-001
First Posted: August 12, 2013    Key Record Dates
Last Update Posted: April 4, 2014
Last Verified: August 2013

Keywords provided by Ottawa Hospital Research Institute:
Intracerebral hemorrhage
Surgical evacuation
Minimally-invasive surgery

Additional relevant MeSH terms:
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Cerebral Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases