Subarachnoid Hemorrhage
Conditions
Keywords
Subarachnoid Hemorrhage, Seizure Prophylaxis, Levetiracetam
Brief summary
Our primary objective is to compare two treatment options for prevention of seizures following a subarachnoid hemorrhage and determine if a short-course regimen of levetiracetam is as efficacious in the prevention of in-hospital seizures when compared to an extended course.
Detailed description
This is a prospective, single-center, randomized, controlled trial. Patients admitted with spontaneous SAH (and meet enrollment criteria) will be randomized to either levetiracetam 1000 mg twice daily for 3 days or levetiracetam 1000mg twice daily until hospital discharge.
Interventions
OTHERBrief LEV
Levetiracetam 1000mg BID x 3 days for prophylaxis
OTHERExtended LEV
Levetiracetam 1000mg BID for length of hospital stay for prophylaxis
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Age \>18 years of age 2. Diagnosis of spontaneous SAH
Exclusion criteria
1. SAH secondary to trauma or arteriovenous malformation 2. Early death (defined as death within 3 days of presentation) 3. Known allergy to levetiracetam 4. Know seizure history on chronic AEDs 5. Pregnancy 6. Current incarceration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-hospital Seizures | from hospital admission to hospital discharge | from admission to In-hospital seizures after aSAH |
Countries
United States
Participant flow
Pre-assignment details
All patients enrolled were assigned to a treatment group.
Participants by arm
| Arm | Count |
|---|---|
| Brief LEV 3 days of LEV 1000mg after aSAH | 35 |
| Extended LEV LEV for hospital stay after aSAH | 49 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Brief LEV | Extended LEV | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 4 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants | 45 Participants | 77 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 5 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) White | 25 Participants | 39 Participants | 64 Participants |
| Sex: Female, Male Female | 23 Participants | 32 Participants | 55 Participants |
| Sex: Female, Male Male | 12 Participants | 17 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 35 | 1 / 49 |
| serious Total, serious adverse events | 0 / 35 | 4 / 49 |
Outcome results
Primary
In-hospital Seizures
from admission to In-hospital seizures after aSAH
Time frame: from hospital admission to hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brief LEV | In-hospital Seizures | 3 Participants |
| Extended LEV | In-hospital Seizures | 1 Participants |