RAMPART Investigator Meeting Study Update 01/06/10.

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Presentation transcript:

RAMPART Investigator Meeting Study Update 01/06/10

Demographics of Randomized Subjects 293 randomized population as of 12/31/09 –39* Low Dose Tier –254 High Dose Tier 44% Females Mean Age: 43 (SD:21; Median: 45; Range: ) –15 (SD: 21; Median: 6; Range: 1-88*) Low Dose Tier –48 (SD: 17; Median: 47; Range: 12-94) High Dose Tier

Demographics of Randomized Subjects Race –39% White –52% Black Ethnicity –71% Non-Hispanic –13% Hispanic

Consent Status of Randomized Subjects 250 (85%) Consent Obtained 12 (4.1%) Consent Declined 11 (3.8%) Notification Only

Average Time Intervals (min:sec) Study Box Open to IM Admin: 1:52 IM to IV Admin: 5:53 Study Box Open to ED Arrival: 19:17

Safety Data Summary Based on 10/23/09 DSMB Open Report Low Dose Tier SAEs –12 subjects randomized / 2 SAEs – 2 (17%) subjects with respiratory depression

Safety Data Summary High Dose Tier SAEs –62 subjects randomized / 24 SAEs – 5 (8%) subjects with recurrent seizure – 6 (10%) subjects with respiratory depression

Safety Data Summary Anticipated Events/Outcomes –18 (24%) endotracheal intubations –10 (14%) recurrent seizures – 2 (3%) hypotension – 2 (3%) IM site injection complications – 1 (1%) IV site insertion complication

Protocol Deviations 72 Deviations 60 (20%) subjects with deviations

Most Common Deviations (N=60) Study Medications administered at inappropriate stage of care: 18 subjects (30%) –12 cases due to IV being given as rescue med (Overall: 37 (13%) subjects IV being given as rescue med) Low dose given to adult: 13 subjects (22%) AE affirmation not completed at discharge: 7 subjects (12%)

Most Common Deviations Not a continuous convulsive seizure: 7 (12%) Not transported to participating ED: 5 (8%) Autoinjector not given in thigh: 5 (8%) AE affirmation not completed at 24-36hr: 4 (7%)