Intracerebral Hemorrhage
Conditions
Keywords
Intracerebral, Hemorrhage, Edema, Statins
Brief summary
Study Objective: To analyze if statins are effective in ameliorating perihematomal edema evolution thereby reducing mortality and improving functional outcomes following spontaneous intracerebral hemorrhage (ICH).
Detailed description
Intracerebral hemorrhage (ICH) causes 10% to 15% of first-ever strokes, with a 30-day mortality rate of 35% to 52% with only 20% expected to be functionally independent at 6 months. No medical or surgical interventions have been found to alter the natural evolution of this disease. The high risk for mortality and poor outcomes seems to occur despite relatively small hematoma volumes and small amounts of neuronal tissue at risk for injury. The reasons for this observation remain unknown; however perihematomal edema formation and inflammation that follows ICH seems to play an important role. The Simvastatin for Intracerebral Hemorrhage Study is a prospective double blinded placebo controlled randomized (1:1) clinical trial that compares outcomes in patients receiving generic simvastatin 80 mg for 14 days or until death or discharge with patients in the placebo group. The hypothesis for our study is that statins ameliorate perihematomal edema evolution thereby reducing mortality and improving functional outcomes following Intracerebral Hemorrhage (ICH). This hypothesis in turn is based on animal data showing suppression of inflammatory reaction and improved neurological outcomes following administration of statins to rodents with experimental ICH, and on a retrospective review of patients admitted to The Johns Hopkins Hospital over the last 7 years with spontaneous ICH which showed significantly better outcomes (decreased 30 day mortality secondary to decreased perihematomal edema) in patients on statins at the time of admission.
Interventions
Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge.
DRUGPlacebo
Patients in study arm II will receive placebo once daily for 14 days or until death or discharge.
Sponsors
National Center for Research Resources (NCRR)
National Institutes of Health (NIH)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patient with CT evidence of ICH admitted within 24 hours of onset of symptoms.
Exclusion criteria
* Age \< 18 or \> 85 * Admission Glasgow Coma Score (GCS) \< 6 * ICH volume \< 10 cc * ICH secondary to trauma, aneurysm, Arterio-Venous Malformation (AVM), tumor or post surgical * Multiple ICH * Associated Subdural hematoma or significant Subarachnoid hemorrhage * History of prior neurologic disease with modified Rankin Scale (mRS) \> 1 * Hematoma evacuation, hemicraniectomy, clot lysis * Myopathy * Active Liver disease * Pregnancy * Statin allergy * Patients on statins prior to admission * Patients with an acute indication for statin therapy (Unstable angina)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perihematomal Edema | Days 7 and 14 | Solitary patient lost to follow up (out of state) |
Countries
United States
Participant flow
Recruitment details
Recruitment period October 2008- June 2009, Inpatient (ICU)
Pre-assignment details
No issues prior to assignment
Participants by arm
| Arm | Count |
|---|---|
| Simvastatin Group Simvastatin 80 mg: Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge. | 1 |
| Placebo Group Placebo: Patients in study arm II will receive placebo once daily for 14 days or until death or discharge. | 0 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Simvastatin Group | Placebo Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Continuous | 62 years | — | 62 years |
| Region of Enrollment United States | 1 participants | — | 1 participants |
| Sex: Female, Male Female | 0 Participants | — | 0 Participants |
| Sex: Female, Male Male | 1 Participants | — | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 |
Outcome results
Primary
Perihematomal Edema
Solitary patient lost to follow up (out of state)
Time frame: Days 7 and 14
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Simvastatin Group | Perihematomal Edema | NA Relative perihematomal edema |