iDEF enrollment instructions

Screening:

  • Inclusion/Exclusion
  • Physical exam
  • mRS
  • ICH Score
  • Vitals
  • GCS
  • NIHSS
  • Prior meds
  • Visual/auditory assessment
  • Medical history
  • Labs (hematology, coagulation parameters, serum chemistry, kidney function test, liver function test, urine analysis, serum albumin)
  • Demographics
  • CT scan
  • Chest x-ray

Enrollment:

  1. Review inclusion/exclusion criteria to ensure eligibility
  2. Get consent from patient or surrogate decision maker
  3. Log into the WebDCU https://webdcu.musc.edu/login.asp to enroll patient and randomize.
  4. Click on the yellow ‘iDEF’ project
  5. Click on the ‘Add New Subject’ icon, enter the gender, race, age, date of informed consent, and date of enrollment, then click [Save Record] at bottom of form
  6. Q12 will appear at the bottom of the screen with a green arrow icon – click this to access Subject CRF
  7. Enter the required data and submit Form 1: Inclusion Exclusion Criteria, Form 6: Glasgow Coma Scale, and Form 43 NIH Stroke Scale. For each form you will have to (Save record) and (Submit CRF). All eligibility criteria must be met or randomization will be   NOTE: for ARDS Criteria- you don’t need albumin and can enter a dummy variable (“0”) if the subject does not meet any other ARDS criteria and the albumin is not back yet
  8. Add the Baseline/Randomization visit by clicking the [Add Subject Visit] button located next to the Subject ID drop-down box in the Site/Spoke header menu. Select the subject ID, select ‘Baseline / Randomization’ from the Visit drop down box, enter the visit date, and click [Save Record].
  9. Click on the green arrow icon in Q05 to access the Subject CRF
  10. Enter the required data and submit Form 2:
  11. Print the page with the randomization form and give the randomization code to inpatient pharmacy – fax 215-349-5841 and call to make sure they receive it 215-662-2907 and to let them know you will be needing the drug
  12. Enter an order for study drug in EPIC – go to order section, type in IDEF – put in order for study drug. You will need a weight if not already entered in EPIC

Prior to Study drug administration

  • NIHSS and  GCS  (immediately prior to drug administration)
  • Blood sample collection sub-study
    • 2 tubes- fill completely and invert 20 times (see instruction sheet for next steps)
  • Vitals

Study Drug Administration (Hour 0):

  • Complete infusion within 25 hours of reconstitution (expiration should be on the bag)
  • Estimated weight ok for initial dose
  • Use dedicated line or central line with a dedicated port
  • Apply warm compresses to the IV injection site throughout each infusion period
  • Infuse at a rate of 1 mL/kg/hour
  • ACTUAL WEIGHT MUST BE RECORDED WITHIN 24 HOURS OF RANDOMIZATION
  • VITALS + NEUROLOGICAL FUNCTIONS MUST BE MEASURED AT LEAST ONCE EVERY FOUR HOURS THROUGHOUT INFUSION

 Prior to Infusion 2       ( 24 hours after Infusion 1)

  • GCS
  • Vitals
  • Visual/auditory assessment
  • NIHSS
  • AE/SAEs
    • Safety monitoring
    • General physical exam
    • Urinary output

Prior to Infusion 3         (24 hours after Infusion 2)

  • GCS
  • Vitals
  • Visual/auditory assessment
  • NIHSS
  • AE/SAEs
    • Safety monitoring
    • General physical exam
    • Urinary output

 

FOR INTUBATED PATIENTS, THE FOLLOWING MUST BE CHECKED AT LEAST ONCE DAILY (repeat checks if ventilator settings/O2 requirements change):

  • PaO2/FiO2 ratio
  • Plateau and peak pressures
  • Chest X-ray results (when available). A chest x-ray is required if the PaO2/FiO2 ratio is <300

 

24 hours post last infusion (+/-6 hours) and as needed

  • Study drug administration record record weight here
  • CT
  • GCS
  • Labs (hematology, coagulation parameters, serum chemistry, kidney function test, liver function test, urine analysis)
  • Blood sample collection sub-study
  • Vitals
  • Visual/auditory assessment
  • NIHSS
  • Chest x-ray Additional imaging
  • Physical exam
  • AE/SAEs

Day 7/discharge (+/-6 hours)

  • GCS
  • mRS
  • Discharge information
  • Vitals
  • MOCA
  • Con meds/therapies
  • Visual/auditory assessment
  • Additional imaging
  • NIHSS
  • AE/SAEs

Day 30 Visit (+/- 7 days)

  • mRS
  • MOCA
  • SIS-16
  • Con meds/therapies
  • Visual/auditory assessment
  • Additional imaging
  • NIHSS
  • AE/SAEs
  • Physical exam

Day 60 Visit (+/- 7 days)

  • mRS
  • Con meds/therapies
  • Additional imaging
  • AE/SAEs

 

Day 90 Visit (+/- 7 days)

  • mRS
  • MOCA
  • SIS-16
  • Con meds/therapies
  • Additional imaging
  • NIHSS
  • AE/SAEs
    • Physical exam

Day 180 visit (+/- 7 days)

  • mRS
  • End of study