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ProTECT III

ProTECT III. Enrollment Reviews – Think Twice. ProTECT III. David W. Wright. Age >18 years. No subjects under the age of 18 have been enrolled!!!. Able to initiate study drug infusion within 4 hours from time of injury. #1 protocol violation (102)

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ProTECT III

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  1. ProTECT III

  2. Enrollment Reviews – Think Twice ProTECT III David W. Wright

  3. Age >18 years • No subjects under the age of 18 have been enrolled!!!

  4. Able to initiate study drug infusion within 4 hours from time of injury • #1 protocol violation (102) • Confirm incident time or last know normal • Do NOT randomize unless you have at least 20 minutes for pharmacy to mix drug • Most are out of our control (pharmacy/OR) • Once randomized you should start drug as soon as possible • Do not delay starting drug infusion to consent family if they arrive • If you don’t have physical documentation (trip sheet) of the time of injury then be diligent about documenting conversations with EMS/Police/Family about time of injury. • When monitoring occurs and physical documentation of time of injury differs from what was initially reported verbally, it is still considered a protocol violation

  5. Moderate to severe brain injury (iGCS 12-4) • Make sure you get a good scene history (if the patient is talking at the scene, they don’t qualify) • Get a GCS off sedation shortly before enrollment • Alcohol alters mental status! – beware of the GCS 12, ETOH >200

  6. Blunt traumatic closed head injury • TBI must be suspected in order to qualify for the study. For the purpose of this study, the definition of TBI is an alteration in brain function, or other evidence of brain pathology, caused by an external force. It is important to recognize that factors other than TBI may be responsible for alterations in mental state at the time of the injury (e.g. pain, posttraumatic shock, medication, alcohol intoxication/abuse and/or recreational drug use). However, these confounders may be associated with the TBI and must be weighed in light of the history of injury.

  7. Enroll or Not to Enroll? Scenario 1 • 20 yo involved in MVC • CT negative • Head laceration • ETOH level 249 • combative • iGCS E4V1M5 (intubated)

  8. High ETOH/High GCS • Is the altered GCS due to alcohol??? • Think twice before randomizing a GCS of 11-12 with ETOH on-board • Repeat a GCS just prior to randomizing

  9. Enroll or Not to Enroll? Scenario 2 40 yo female fell down flight of stairs 2 minute Tonic/clonic seizure enroute to hospital Ativan 2 mg IV given Intubated for airway protection iGCS E1V1M4

  10. Seizure/Post-Ictal • Is altered GCS due to a post-ictal state? • How long did the seizure last? • Were benzo’s given that could be affecting GCS?

  11. Enroll or Not to Enroll? • Scenario 3 • 85 yo ground level fall • GCS 4 • Cataracts – difficult to see good pupil response • Severe edema on CT • Neurosurgery will not confirm if will go to OR • Family not available • Trauma team too busy to discuss

  12. Survivable? • What is the pre-injury mRS (functionality)? • Co-morbid conditions? • Philosophy of treating team/Neurosurgeon? • Other injuries? • Pupil response? • Why did he fall? Is there another issue – like ICH, or MI?

  13. Enrolled – but, • Neurosurgery takes to the OR • You randomize, but don’t get drug started • NS comes out of OR and says, this is not survivable, we just closed him up. • Patient unstable, family on the way, NS is going to tell them not survivable • DO YOU START THE DRUG?

  14. Enroll or Not to Enroll? • Scenario 4 • 24 yo M motorcyclist found in ditch on busy highway • GCS 7, pupils responsive, no ETOH • EMS dispatch was at 01:30 • Patient arrived at 0:230

  15. Time of Injury? • Patient in ditch – really visible • What is a busy highway? • Motorcycle in tree? • No witness? • Anyone see him before the wreck?

  16. Can you find the women and child? The obvious may not be so obvious!

  17. HOTLINE • If in DOUBT, call the HOTLINE! 1-888-359-2221

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