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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
Information provided by (Responsible Party):
Robert Silbergleit, University of Michigan
ClinicalTrials.gov Identifier:
NCT00809146
First received: December 15, 2008
Last updated: April 13, 2012
Last verified: April 2012
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
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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
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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  
Number of Participants  
[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  
History of epilepsy  
[units: participants]
     
Yes     293     295     588  
No     111     103     214  
Not documented     44     47     91  
Final diagnosis [2]
[units: participants]
     
Status epilepticus     404     399     803  
Nonepileptic spell     31     32     63  
Undetermined     13     14     27  
[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.
[2] Determined by medical record review at the time of hospital discharge



  Outcome Measures
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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: during hospitalization ]

7.  Secondary:   Number of Subjects With IM Injection-site Complications   [ Time Frame: during hospitalization ]

8.  Secondary:   Number of Subjects With IV Injection-site Complications   [ Time Frame: during hospitalization ]

9.  Secondary:   Length of Intensive Care Unit (ICU) Stay in Days   [ Time Frame: during hospitalization ]

10.  Secondary:   Length of Hospital Stay in Days   [ Time Frame: during hospitalization ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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


No publications provided by University of Michigan

Publications automatically indexed to this study:

Responsible Party: Robert Silbergleit, University of Michigan
ClinicalTrials.gov Identifier: NCT00809146     History of Changes
Other Study ID Numbers: R01NS053031, 5U01NS056975-02
Study First Received: December 15, 2008
Results First Received: March 18, 2012
Last Updated: April 13, 2012
Health Authority: United States: Food and Drug Administration