James Quinn
Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART)
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
This is a double-blind randomized non-inferiority clinical trial of the efficacy of IM midazolam versus IV lorazepam in the prehospital treatment of status epilepticus by paramedics. All patients for whom a participating paramedic ambulance is dispatched are screened for eligibility in the study. Adult and pediatric patients with continuing seizure activity after EMS arrival and meeting all other inclusion and exclusion criteria will be enrolled in this trial. Subjects are followed through discharge from the hospital.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Midazolam
Phase:
Phase 3Eligibility
Ages Eligible for Study:
Any Age to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
1. Paramedics or reliable witnesses verify continuous or repeated convulsive seizure activity of more than 5 minutes, or patient does not regain consciousness (operationally defined as meaningful speech or obeying commands) between seizures.
2. Patient is still seizing on paramedic arrival; or, if not, patient was unresponsive on paramedic arrival and has a qualifying generalized seizure without regaining consciousness (as above). Patients must be convulsing at the time of treatment to be enrolled.
3. Estimated weight equal to or greater than 13 kg
4. Subject to be transported to a RAMPART participating hospital
Key Exclusion Criteria:
1. Major trauma as the precipitant of the seizure
2. Hypoglycemia (glucose < 60 mg/dL)
3. Known allergy to midazolam or lorazepam
4. Cardiac Arrest or Heart Rate (HR) <40 beats per minute
5. Medical alert tag marked with ?RAMPART declined?
6. Prior treatment of this seizure with diazepam autoinjector as part of another study
7. Known pregnancy
8. Prisoners
Additional Study Details
Official Title:
A double-blind randomized clinical trial of the efficacy of IM midazolam versus IV lorazepam in the pre-hospital treatment of status epilepticus by paramedicsAnticipated start date:
3/16/2009Lead Sponsor:
University of MichiganCollaborator(s):
- Neurological Emergencies Treatment Trials Network
- University of California San Francisco
- Medical University of South Carolina
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
ParallelEndpoints:
Safety/EfficacyPrimary Outcomes:
- The binary outcome variable measuring whether or not there is termination of convulsive seizure activity prior to ED arrival after an initial dose of study medication without the need for a second "rescue" dose of benzodiazepine by EMS.
Secondary Outcomes:
- Times from EMS arrival to convulsive seizure termination & from treatment initiation to seizure termination, frequency of endotracheal intubation, frequency & duration of hospitalization & ICU admission, & frequency of acute seizure recurrence.
Total Number to be Enrolled:
800Total Number to be Enrolled at Stanford:
50More Information
Secondary ID(s):
- IRB# 13195
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
3/16/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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