Q: Who is eligible for POST-ICECAP?
A:
- Age ≥ 18 years
- Coma after resuscitation from OHCA
- Patients who were either screened or enrolled in the ICECAP trial
- Received targeted temperature management
- Patient survived to 1 month
- Signed ICF by a patient or an authorized representative
Q: What is the definition of “Received targeted temperature management” in the inclusion criteria?
A: Coming Soon
Q: What is the enrollment window?
A: 30 days after cardiac arrest. Subjects who are 31 days post cardiac arrest are not eligible.
Q: Does the NOA need to be blinded?
A: No, the NOA does not need to be blinded in POST-ICECAP. If the 3-month assessment is being done for ICECAP, follow the ICECAP rules that the NOA is blinded
Q: What is the time commitment for NOA training including Modified Rankin, NIH-Toolbox, Neuro-Qol, and BTACT?
A: Approximately 8 hours i.e. one business day
Q: How long do the NOA assessments take during each visit?
A: Approximately 60 minutes for telephone visits and 90 minutes for in-person visits
Q: Do subjects need to be re-consented when they regain the capacity to consent?
A: No. If the subject is cognitively impaired at the time of consent, enrollment will be based on obtaining consent from a legally authorized representative (LAR). Subjects will not need to be consented when they gain the capacity to consent. However, participation is voluntary therefore subjects may withdraw from the study at any time.
Q: If a subject needs to end the telephone interview before completion, can the remaining interview be completed at a later time?
A: Yes. However, any neuropsych test should be completed in its entirety and not as 2 separate interviews. Letting the person take a break, and completing some other instruments on a separate call or day is okay. And best to keep these calls close together in time.
Q: Can the outcomes questionnaires be printed/completed on paper and then transcribed to WebDCU?
A: Yes, except NIH Toolbox and Neuro QoL - these are administered on iPads.
Q: Can a subject co-enroll in another trial?
A: Yes. Please contact us and we can assist in the coordination of visits and selection of study assessments.
Q: Can a site participate in POST-ICECAP if not participating in ICECAP?
A: No, not at this time.