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Investigator Meeting January 2010

Investigator Meeting January 2010. Protocol Review and Refresher. SAE Reporting. Key Points Narrative Templates Better narratives. RS. Adverse Events – key points. AEs are any UNTOWARD medical occurrence in a subject

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Investigator Meeting January 2010

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  1. Investigator MeetingJanuary 2010 Protocol Review and Refresher

  2. SAE Reporting • Key Points • Narrative Templates • Better narratives RS

  3. Adverse Events – key points AEs are any UNTOWARD medical occurrence in a subject Do not report events EXISTING PRIOR to randomization (unless there is a change in severity) Report the DIAGNOSIS, not the symptoms: Fever, cough, chest pain, crackles = pneumonia Death, surgery, intubation, etc. are NOT adverse events. They are outcomes of adverse events CD

  4. Adverse Events – key points Exception to the diagnosis not symptom rule! We want all endotracheal intubations reported…. But intubation is still the outcome not the event So if intubation is for airway protection only, consider using “coma” or “sedation” even though these are symptoms. RS

  5. Adverse Events – key points From Randomization through 24 hrs: Report all AEs From 24 hours through EOS: Report only serious AEs Follow previously reported AEs to resolution or end of study (whichever comes first) CD

  6. Serious if: Fatal, Life-Threatening, Result in hospitalization (prolonged hospitalization), Result in disability/congenital anomaly, or Require intervention to prevent permanent impairment or damage Submit SAEs within 24 hours of discovery Serious AEs – key points CD

  7. SAE Reporting -Relatedness algorithm Not Related • The timing is wrong and there was clearly another cause Unlikely (both of the following, but timing doesn’t matter) • Another cause is possible • Not something the intervention is known to cause Possibly (2 of 3)or Probably (must have all 3) • Timing is suggestive. • No other likely causes. • This is something the intervention is known to cause. Definitely (must have all 3) • Timing suggests intervention caused the problem. • No other possible cause. • This is something the intervention is known to cause. RS

  8. Better narratives - sample Respiratory Depression A 38 year old male with a history of seizures, was found seizing and was enrolled in RAMPART at approximately 20:45 on 9/1/2009. The patient was unresponsive but not convulsing at hospital arrival at 20:59. He subsequently underwent endotracheal intubation for respiratory depression in the ED at 21:20. The patient was not thought to be seizing at the time of intubation, but was felt to have respiratory depression from the combination of alcohol intoxication and benzodiazepines. The patient was treated with propofol and admitted to the ICU. The patient was subsequently extubated on 9/2/2009. RS

  9. Better narratives – key points • Concise, not comprehensive • All necessary detail, no unnecessary detail • Provide age, only pertinent history • Include time and date of enrollment CD

  10. Better narratives – key points • Describe the adverse event • If treatment was given, report the response • Provide the outcome if known CD

  11. Better narratives – key points • Seizing on arrival? Seizing at time of SAE? • Generic drug names, not brand names • Do not capitalize generic drug names CD

  12. Better narratives – key points • When reporting times closely following the previous times, do not add dates • When reporting events on subsequent days, only report times if relevant • In addition to the times, report the time interval from enrollment to SAE when appropriate CD

  13. Narrative templaterespiratory depression A [age] year old [male/female] was found seizing on [date] at [time] and was enrolled in RAMPART. The patient [stopped/did not stop] seizing prior to ED arrival. The patient subsequently underwent endotracheal intubation for respiratory depression [by EMS/in the ED] at [time]. The patient [was/was not] still thought to be seizing at the time of intubation. [The patient was subsequently extubated on [date].] [The patient remained intubated as of [date] because of [suspected etiology].] RS

  14. Let’s edit one together

  15. Intubation 67 year old Black female found seizing and was enrolled in Rampart on 4-Sep-2009 at unknown time (EMS sheets were not turned in). EMS brought her into hospital at 00:25 on 4-Sep-2009 in active seizing state. Had come around briefly in squad following Rampart kit usage and then began seizing again on entering the hospital. Seizing continued and at 01:03 patient was intubated following administration of 20 mg etomidate and 200 mg succinylcholine. At 01:04 was given vecuronium 5 mg. At 1:06 was given 2 mg of lorazepam. AT 10:39, a propofol drip was started. Patient was admitted to the ICU at 03:57 with continuing seizures by EEG. Patient remained intubated until noon on 4-Sep-2009 when she was extubated. An MRI on 06-Sep-2009 at 11:24 confirmed ischemic infarct along left occipitopariental lobe as well as portions of the left centrum ovale.Recurrent Seizure

  16. Intubation Recurrent Seizure 67 year old Black female found seizing and was enrolled in Rampart on 4-Sep-2009 at unknown time (EMS sheets were not turned in). EMS brought her into hospital at 00:25 on 4-Sep-2009 in active seizing state. Had come around briefly in squad following Rampart kit usage and then began seizing again on entering the hospital. Seizing continued and at 01:03 patient was intubated following administration of 20 mg etomidate and 200 mg succinylcholine. At 01:04 was given vecuronium 5 mg. At 1:06 was given 2 mg of lorazepam. AT 10:39, a diprivan drip was started. Patient was admitted to the ICU at 03:57 with continuing seizures by EEG. Patient remained intubated until noon on 4-Sep-2009 when she was extubated. An MRI on 06-Sep-2009 at 11:24 confirmed ischemic infarct along left occipitopariental lobe as well as portions of the left centrum ovale.

  17. Recurrent Seizure 67 year old Black female found seizing and was enrolled in Rampart on 4-Sep-2009 at unknown time (EMS sheets were not turned in).67 year old female was found seizing on 9/4/2009 prior to 00:25 and was enrolled in RAMPART. EMS brought her into hospital at 00:25 on 4-Sep-2009 in active seizing state. Had come around briefly in squad following Rampart kit usage and then began seizing again on entering the hospital. Seizing continued and at 01:03 patient was intubated following administration of 20 mg etomidate and 200 mg succinylcholine. At 01:04 was given vecuronium 5 mg. At 1:06 was given 2 mg of lorazepam. AT 10:39, a diprivan drip was started. Patient was admitted to the ICU at 03:57 with continuing seizures by EEG. Patient remained intubated until noon on 4-Sep-2009 when she was extubated. An MRI on 06-Sep-2009 at 11:24 confirmed ischemic infarct along left occipitopariental lobe as well as portions of the left centrum ovale.

  18. Recurrent Seizure 67 year old female was found seizing on 9/4/2009 prior to 00:25 and was enrolled in RAMPART. EMS brought her into hospital at 00:25 on 4-Sep-2009 in active seizing state. Had come around briefly in squad following Rampart kit usage and then began seizing again on entering the hospital.The patient briefly stopped convulsing prior to ED arrival, but was still seizing upon ED arrival. Seizing continued and at 01:03 patient was intubated following administration of 20 mg etomidate and 200 mg succinylcholine. At 01:04 was given vecuronium 5 mg. At 1:06 was given 2 mg of lorazepam. AT 10:39, a diprivan drip was started. Patient was admitted to the ICU at 03:57 with continuing seizures by EEG. Patient remained intubated until noon on 4-Sep-2009 when she was extubated. An MRI on 06-Sep-2009 at 11:24 confirmed ischemic infarct along left occipitopariental lobe as well as portions of the left centrum ovale.

  19. Recurrent Seizure 67 year old female was found seizing on 9/4/2009 prior to 00:25 and was enrolled in RAMPART. The patient briefly stopped convulsing prior to ED arrival, but was still seizing upon ED arrival. Seizing continued and at 01:03 patient was intubated following administration of 20 mg etomidate and 200 mg succinylcholine. At 01:04 was given vecuronium 5 mg. The patient subsequently underwent endotracheal intubation for status epilepticus in the ED at 01:03. The patient was still seizing at the time of intubation. At 1:06 was given 2 mg of lorazepam. AT 10:39, a diprivan drip was started. Patient was admitted to the ICU at 03:57 with continuing seizures by EEG. Patient remained intubated until noon on 4-Sep-2009 when she was extubated. An MRI on 06-Sep-2009 at 11:24 confirmed ischemic infarct along left occipitopariental lobe as well as portions of the left centrum ovale.

  20. Recurrent Seizure 67 year old female was found seizing on 9/4/2009 prior to 00:25 and was enrolled in RAMPART. The patient briefly stopped convulsing prior to ED arrival, but was still seizing upon ED arrival. The patient subsequently underwent endotracheal intubation for status epilepticus in the ED at 01:03. The patient was still seizing at the time of intubation. At 1:06 was given 2 mg of lorazepam. AT 10:39, a diprivan drip was started. Patient was admitted to the ICU at 03:57 with continuing seizures by EEG.Continuing seizures were treated with lorazepam and then propofol and the patient was admitted to the ICU at 03:57. EEG confirmed continuing seizure activity at that time. Patient remained intubated until noon on 4-Sep-2009 when she was extubated. An MRI on 06-Sep-2009 at 11:24 confirmed ischemic infarct along left occipitopariental lobe as well as portions of the left centrum ovale.

  21. Recurrent Seizure 67 year old female was found seizing on 9/4/2009 prior to 00:25 and was enrolled in RAMPART. The patient briefly stopped convulsing prior to ED arrival, but was still seizing upon ED arrival. The patient subsequently underwent endotracheal intubation for status epilepticus in the ED at 01:03. The patient was still seizing at the time of intubation. Continuing seizures were treated with lorazepam and then propofol and the patient was admitted to the ICU at 03:57. EEG confirmed continuing seizure activity at that time. Patient remained intubated until noon on 4-Sep-2009 when she was extubated. An MRI on 06-Sep-2009 at 11:24 confirmed ischemic infarct along left occipitopariental lobe as well as portions of the left centrum ovale.The patient was subsequently extubated around 12:00 on 9/4/2009.

  22. Recurrent Seizure 67 year old female was found seizing on 9/4/2009 prior to 00:25 and was enrolled in RAMPART. The patient briefly stopped convulsing prior to ED arrival, but was still seizing upon ED arrival. The patient subsequently underwent endotracheal intubation for status epilepticus in the ED at 01:03. The patient was still seizing at the time of intubation. Continuing seizures were treated with lorazepam and then propofol and the patient was admitted to the ICU at 03:57. EEG confirmed continuing seizure activity at that time. The patient was subsequently extubated around 12:00 on 9/4/2009.

  23. rampart.umich.edu

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