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Seizure Prophylaxis With Levetiracetam in Aneurysmal Subarachnoid Hemorrhage - Pilot Study (SPLASH - Pilot)

Vanderbilt University Medical Center logo

Vanderbilt University Medical Center

Status and phase

Withdrawn
Phase 4

Conditions

Seizures
Subarachnoid Hemorrhage

Treatments

Drug: levetiracetam

Study type

Interventional

Funder types

Other

Identifiers

NCT01935908
SPLASH-P1

Details and patient eligibility

About

The purpose of this study is to determine the feasibility of prospectively enrolling and randomizing patients with aneurysmal subarachnoid hemorrhage (aSAH) to receive levetiracetam or not to receive levetiracetam, and documenting in-hospital and follow-up clinical variables.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • ≥ 18 years of age
  • ≤ 75 years of age
  • Newly diagnosed aneurysmal subarachnoid hemorrhage

Exclusion criteria

  • One or more antiepileptic medication is taken as a pre-admission medication
  • Seizure occurrence in the field or in the emergency department, or anytime before consent could be obtained
  • Inability to obtain informed consent from the patient, or from the patient's appropriate surrogate

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Control Group
No Intervention group
Description:
The control group will not receive levetiracetam as seizure prophylaxis.
Treatment Group
Active Comparator group
Description:
levetiracetam 500mg in adults, twice daily, administered by mouth, per tube, or IV. The route of administration will be dependent upon the patient's clinical status and ability to tolerate each form. In descending order of preference, route of administration will be: oral, per tube, IV.
Treatment:
Drug: levetiracetam

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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