ICECAP FAQs
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Q: Do I submit my site’s application to Advarra?
A: No. Sites do NOT submit applications directly to Advarra. The SIREN CCC will submit site applications to Advarra once the site has completed the “Initial Site Submission” in WebDCU under ICECAP – Central IRB. Sites should submit requests to their local IRBs to cede to Advarra. The ceding request to the local IRB and the ceding acknowledgment from the local IRB must be uploaded and accepted in WebDCU before site applications are submitted. Sites should also work on uploading e-DOAs and other regulatory documents into WebDCU.
Q: What is required to submit in WebDCU for the central IRB?
A: Sites must complete three tables in WebDCU:
- Site Overview Table: Go to the [SIREN] icon in WebDCU → Click on [Central IRB] → Click on [Site Overview] to complete the table. If already completed, review and verify with the site manager.
- Site Regulatory Inspection History Table: Go to the [SIREN] icon in WebDCU → Click on [Central IRB] → Click on [Site Regulatory Inspection History]. Complete a new record for each regulatory inspection in the last five years. If there were no inspections, attest to that.
- Initial Site Submission Table: Go to the [HOBIT] icon in WebDCU → Click on [Central IRB] → Click on [Initial Site Submission] to complete. Ensure all regulatory and personnel documents are uploaded before completing this table.
Q: Can patients with subarachnoid hemorrhage be enrolled in ICECAP?
A: ICECAP does not require a head CT before enrollment, so SAH is not an explicit exclusion. However, if a CT is performed:
- No CT before enrollment: If the patient meets all other criteria, they can be enrolled.
- Aneurysmal SAH on CT: Cooling to 33 degrees is not clinically indicated, and SAH confounds outcomes, so the patient should not be enrolled.
- Small traumatic SAH on CT: Enrollment depends on clinical judgment—if small SAH is not a contraindication to cooling, the patient may still be eligible.
Q: What is the guidance on excluding patients with “pre-existing neurological disability or condition that confounds outcome determination”?
A: Patients who, even if returned to baseline, would still have a poor study outcome should be excluded. This includes those requiring skilled nursing care, non-communicative patients, and those who do not perform ADLs independently. Clinical judgment is required for borderline cases.
Q: Are patients placed on ECMO for cardiac arrest (ECPR) eligible?
A: No, these patients are excluded due to hemodynamic instability (See MOP section 3.1).
Q: What if a patient worsens hemodynamically during the study and requires mechanical support?
A: The trial does not restrict mechanical support use post-enrollment. Targeted temperature management should continue if clinically safe. Patients remain in the study on an intention-to-treat basis.
Q: Are patients with VADs who experience witnessed out-of-hospital cardiac arrest eligible?
A: No, due to the vague nature of OHCA in VAD patients and their inherent hemodynamic instability.
Q: Are patients requiring a balloon pump or Impella eligible?
A: No. Patients requiring these devices are excluded due to hemodynamic instability (See MOP section 3.1).
Q: Are patients arriving with a temperature <34°C eligible?
A: Only if active cooling measures were initiated within 4 hours. Patients spontaneously hypothermic at arrival without cooling measures are not eligible.
Q: Why did you get an IDE if you are not testing the safety and efficacy of an investigational device?
A: The trial tests hypothermia duration, not a device. However, since FDA-regulated devices are used and FDA intends to use the trial for regulatory science, an IDE was obtained in collaboration with FDA.
Q: Will the sponsor submit the ICECAP study to CMS for Medicare Coverage approval?
A: No, because there are no billable study-required devices or services. Hypothermia devices must already be in use as part of standard care before enrollment. No research-related costs are billed to insurance.
Q: Does being on multiple pressors count as hemodynamic instability?
A: Not necessarily. Hemodynamic instability is defined as persistent hypotension (SBP <80 mmHg) despite vasopressors. Multiple pressors alone do not exclude a patient.
Q: Can the clinical team rewarm a patient earlier than the allocated duration or change the target temperature?
A: Physicians may depart from the protocol if clinically necessary, but protocol deviations should be reported. Cooling is rarely the cause of instability, and premature rewarming may worsen prognosis.
Q: Why do we need to continuously monitor core body temperature from two locations?
A: While not required, it improves safety and data accuracy, preventing misreadings due to probe failure or migration.
Q: Is the SIREN e-consent platform Part 11 compliant?
A: Yes. The University of Michigan’s REDCap implementation is 21 CFR Part 11 compliant. Supporting documentation is available through SIREN.