Clinical Trial: Observational Study of Safety and Outcomes After Minimally Invasive Surgery for Intracerebral Hemorrhage

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Observational

Official Title: Clinical Outcomes Following Parafascicular Surgical Evaluation of Intracerebral Hemorrhage: A Pilot Study

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.


Detailed Summary:

1.1 Intracerebral hemorrhage (ICH) morbidity, mortality, and functional outcomes. ICH is the most severe form of stroke: 30-day mortality is 40%, and 80% of survivors are physically disabled. Baseline hematoma volume and expansion are the most important determinants of outcome and are often therapeutic targets for trials. To date, there is no accepted medical therapy for ICH, particularly in supratentorial hematomas. Attempts to mitigate neuronal injury with treatments such as aggressive blood pressure lowering, hemostatic agents, reversal of anticoagulation, and surgical evacuation have been unsuccessful. We need an innovative approach to treat this lethal and disabling disease.

1.2 ICH surgery as a therapeutic approach. Mechanical and toxic effects of an accumulating intracerebral hematoma play an important pathophysiological role in ICH related brain injury. However, randomized controlled trials of hematoma evacuation have yielded inconsistent results. The largest randomized controlled trial of surgery for ICH failed to show a clinical benefit, possibly due to differences in surgical protocols, a 25% cross-over rate from medical to surgical arms, and substantial delays in onset-to-surgery times (median 3 days). This trial also raised the possibility that collateral injury to normal tissue during surgery can adversely affect outcome, as patients who appeared to benefit most were those with superficial and easily accessible hematomas. A subsequent meta-analysis indicated surgery may be beneficial for acute ICH with careful patient selection and short onset-to-surgery times. But at present, the surgical evacuation of ICH remains an unproven therapy.

1.3 Minimally invasive surgery for ICH. Traditionally, two of the strongest influences on treatment selection have been hematoma depth and dominance of the hemisphere involved,
Sponsor: Ottawa Hospital Research Institute

Current Primary Outcome:

  • 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.
  • 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.

  • 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.
  • 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.
  • 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 c

    Original Primary Outcome: Same as current

    Current Secondary Outcome: 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.


    Original Secondary Outcome: Same as current

    Information By: Ottawa Hospital Research Institute

    Dates:
    Date Received: July 22, 2013
    Date Started: July 2013
    Date Completion: October 2014
    Last Updated: April 2, 2014
    Last Verified: August 2013