Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Paramedic Treatment of Prolonged Seizures by Intramuscular Versus Intravenous Anticonvulsant Medications (RAMPART)

This study has been completed.
Sponsor:
Collaborators:
Medical University of South Carolina
University of California, San Francisco
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Robert Silbergleit, University of Michigan
ClinicalTrials.gov Identifier:
NCT00809146
First received: December 15, 2008
Last updated: May 10, 2016
Last verified: May 2016
Results First Received: March 18, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Status Epilepticus
Interventions: Drug: Intramuscular route of active treatment
Drug: Intravenous route of active treatment

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects treated for status epilepticus in the prehospital setting by paramedics were enrolled at the scene between June 2009 and January 2011. A total of 1023 subject enrollments represented 893 unique subjects with a reenrollment rate of 13%. RAMPART involved 4314 paramedics, 33 EMS agencies, and 79 receiving hospitals across the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Number of patients enrolled includes any repeat enrollments for those who presented to emergency medical services (EMS) with status epilepticus more than once. The number assigned to treatment in the intention-to-treat analysis includes every patient who was enrolled in the study but only the initial enrollment for those enrolled more than once.

Reporting Groups
  Description
Intramuscular (IM) Anticonvulsant This group gets active treatment with an anticonvulsant by the intramuscular route of administration. IM administration by autoinjector of midazolam 5 mg for subjects under estimated weight of 40 kg or midazolam 10 mg for subjects with estimated weight of 40 kg or above, IV administration of matching volume of IV flush.
Intravenous (IV) Anticonvulsant This group gets active treatment with an anticonvulsant by the intravenous route of administration. IV administration of lorazepam 2 mg for subjects under estimated weight of 40 kg or midazolam 4 mg for subjects with estimated weight of 40 kg or above, IM administration by autoinjector of matching volume of saline.

Participant Flow:   Overall Study
    Intramuscular (IM) Anticonvulsant   Intravenous (IV) Anticonvulsant
STARTED   448   445 
COMPLETED   448   445 
NOT COMPLETED   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Intramuscular (IM) Anticonvulsant This group gets active treatment with an anticonvulsant by the intramuscular route of administration. IM administration by autoinjector of midazolam 5 mg for subjects under estimated weight of 40 kg or midazolam 10 mg for subjects with estimated weight of 40 kg or above, IV administration of matching volume of IV flush.
Intravenous (IV) Anticonvulsant This group gets active treatment with an anticonvulsant by the intravenous route of administration. IV administration of lorazepam 2 mg for subjects under estimated weight of 40 kg or midazolam 4 mg for subjects with estimated weight of 40 kg or above, IM administration by autoinjector of matching volume of saline.
Total Total of all reporting groups

Baseline Measures
   Intramuscular (IM) Anticonvulsant   Intravenous (IV) Anticonvulsant   Total 
Overall Participants Analyzed 
[Units: Participants]
 448   445   893 
Age 
[Units: Years]
Mean (Standard Deviation)
 43  (22)   44  (22)   43  (22) 
Age, Customized 
[Units: Participants]
     
0-5 years   32   29   61 
6-10 years   15   20   35 
11-20 years   28   21   49 
21-40 years   114   112   226 
41-60 years   169   169   338 
>61 years   90   94   184 
Gender 
[Units: Participants]
     
Female   198   207   405 
Male   250   238   488 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   49   57   106 
Not Hispanic or Latino   310   290   600 
Unknown or Not Reported   89   98   187 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   3   5   8 
Asian   8   14   22 
Native Hawaiian or Other Pacific Islander   2   1   3 
Black or African American   229   224   453 
White   165   183   348 
More than one race   9   5   14 
Unknown or Not Reported   32   13   45 
Region of Enrollment 
[Units: Participants]
     
United States   448   445   893 
Dose tier [1] 
[Units: Participants]
     
children with an estimated weight of 13 to 40 kg   62   59   121 
Children estimated >40kg and All Adults   386   386   772 
[1] All adults and those children with an estimated body weight of more than 40 kg received either 10 mg of intramuscular midazolam followed by intravenous placebo or intramuscular placebo followed by 4 mg of intravenous lorazepam. Children with an estimated weight of 13 to 40 kg received either 5 mg of intramuscular midazolam followed by intravenous placebo or intramuscular placebo followed by 2 mg of intravenous lorazepam.
History of epilepsy 
[Units: Participants]
     
Yes   293   295   588 
No   111   103   214 
Not documented   44   47   91 
Final diagnosis [1] 
[Units: Participants]
     
Status epilepticus   404   399   803 
Nonepileptic spell   31   32   63 
Undetermined   13   14   27 
[1] Determined by medical record review at the time of hospital discharge


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects With Termination of Seizures at ED Arrival With no Rescue Therapy Given   [ Time Frame: Duration of prehospital care, outcome is determined upon arrival at the ED on the day of enrollment (average 20 minutes). ]

2.  Secondary:   Number of Subjects With Endotracheal Intubation Within 30 Min After ED Arrival   [ Time Frame: anytime before 30 minutes after ED arrival ]

3.  Secondary:   Number of Subjects Hospitalized   [ Time Frame: at ED disposition on day of enrollment ]

4.  Secondary:   Number of Subjects Admitted to an Intensive Care Unit (ICU)   [ Time Frame: at time of disposition on day of enrollment ]

5.  Secondary:   Number of Subjects With Recurrent Seizure Within 12 Hours After ED Arrival   [ Time Frame: within 12 hours after ED arrival ]

6.  Secondary:   Number of Subjects With Hypotension   [ Time Frame: participants were followed for the duration of hospital stay, an average of 6 days ]

7.  Secondary:   Number of Subjects With IM Injection-site Complications   [ Time Frame: participants were followed for the duration of hospital stay, an average of 6 days ]

8.  Secondary:   Number of Subjects With IV Injection-site Complications   [ Time Frame: participants were followed for the duration of hospital stay, an average of 6 days ]

9.  Secondary:   Length of Intensive Care Unit (ICU) Stay in Days   [ Time Frame: participants were followed for the duration of hospital stay, an average of 6 days ]

10.  Secondary:   Length of Hospital Stay in Days   [ Time Frame: participants were followed for the duration of hospital stay, an average of 6 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Robert Silbergleit MD, Principal Investigator
Organization: University of Michigan
phone: 734-232-2142
e-mail: robie@umich.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Robert Silbergleit, University of Michigan
ClinicalTrials.gov Identifier: NCT00809146     History of Changes
Other Study ID Numbers: R01NS053031
5U01NS056975-02 ( US NIH Grant/Contract Award Number )
Study First Received: December 15, 2008
Results First Received: March 18, 2012
Last Updated: May 10, 2016
Health Authority: United States: Food and Drug Administration