FAQs
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Q: What is the management strategy for the BOOST-3 trial?
A: BOOST-3 is a trial assessing a management strategy of patient care; it is NOT a study assessing an experimental drug, device, or procedure. The procedures being done for this trial, including placement of intracranial monitoring probes, are part of the routine care for patients admitted to the hospital with severe TBI.
Q: Do you have the IDE #?
A: No, there is an IDE waiver from the FDA since PbtO2 devices are FDA-cleared for this indication.
Q: Where can I get more information on Integra/Raumedic products or their IFUs?
A:
Raumedic: https://www.raumedic.com/us/neuromonitoring/neuro-icu/oxygen-partial-pressure/
Integra: http://www.integralife.eu/products/neuro/neurocritical-care/pbto2-licox/
Q: What do you do if a participant says they want to withdraw from the study?
A: Participants always have the right to withdraw at any time. Study personnel should clarify what they want to stop, as many withdrawal requests are about specific study components rather than full withdrawal. If they agree, you may continue monitoring their medical records. Otherwise, document their withdrawal and respect their wishes.
Q: At what point is it permissible to enroll a patient under EFIC?
A: If an LAR is not available before successful placement of intracranial monitoring, the patient can be enrolled under EFIC immediately. Attempts to locate the LAR should continue, and consent should be sought as soon as possible.
Q: If a family member is not available to provide consent but is available on the phone, can the patient be enrolled under EFIC?
A: If the LAR is reached by phone, the study must be discussed. If they object, the patient cannot be enrolled. If they agree but cannot physically sign or use e-consent before probe placement, the patient may be enrolled under EFIC.
Q: How does the possibility of getting a remote e-consent affect the rule about who can be enrolled with EFIC?
A: The potential for remote e-consent does not change EFIC rules. If an LAR is unavailable for written or e-consent before probe placement, the patient can be enrolled under EFIC.
Q: What if a subject tests positive for COVID?
A: COVID-19 testing is not required for participation. Mild or asymptomatic COVID does not affect eligibility. Severe COVID-related impairments may impact eligibility, but pre-existing COVID is not a reportable AE unless symptoms worsen significantly.
Q: Why are children included in BOOST-3?
A: Children aged 14+ are included. Younger children are excluded due to non-validated outcome measures and different cerebrovascular physiology, which may confound results.
Q: Will BOOST-3 allow for co-enrollment into any other studies?
A: Co-enrollment is allowed with prior study leadership approval. However, TXA co-enrollment is not permitted.
Q: Is it required that the treatment team always adhere to the protocol?
A: Yes. There is flexibility in selecting interventions within each Tier, but adherence to Tier 1 and Tier 2 treatments is required unless medically contraindicated.
Q: Is it okay to disable the alarm on the ICP/PbtO2 monitors?
A: Only the PbtO2 alarm in the blinded group may be disabled. In the unblinded group, alarms should remain active.
Q: What is the length of time in which subjects must be randomized into BOOST-3?
A: Patients must be randomized within 6 hours of arrival to the enrolling hospital and no later than 12 hours post-injury.
Q: What are the documentation requirements for capturing Tier therapies during the monitoring period?
A: Interventions should be documented in the Moberg CNS monitor. Nurses can use the Nursing Documentation Tool as a backup.
Q: When does a scenario begin?
A: A scenario begins when an abnormality is noted on the Moberg CNS monitor and lasts until values normalize for 30 minutes.
Q: How long will placement of the ICP and PbtO2 probes take? Where will this procedure be performed?
A: The procedure takes approximately 20-30 minutes, typically in the ICU or OR.
Q: What do you do if it appears that the PbtO2 monitor is not functioning properly?
A: If two FiO2 challenges fail, replace the probe in the intervention group. No replacement is done in the blinded group.
Q: What if a treatment listed in the tiers is already being done before an abnormality occurs?
A: Pre-existing treatments should not be recorded as new interventions. However, additional interventions may be selected from Tier 1 or Tier 2 as needed.
Q: Does my site have to use the Central/Single IRB?
A: Yes, NIH requires a single IRB for all SIREN trials.
Q: What is the Central IRB #?
A: Pro00030585
Q: What is expected of each site for the EFIC process for this trial?
A: Sites must complete community consultation and public disclosure (CC/PD) activities. Templates and resources will be provided.
Q: How will BOOST 3 data be managed?
A: Data is managed in WebDCU™, hosted at MUSC, including CRFs, regulatory documents, and EFIC activities.
Q: Who are the personnel at the SIREN CCC and who should we communicate with for various trial-related questions?
A: Contact BOOST-contact@umich.edu for trial-related questions.
Q: What is the per-subject reimbursement?
A: Approximately $12,500, inclusive of indirects.
Q: Are we billing insurance for the procedure?
A: Yes, placement of probes is routine care and billed accordingly.
Q: How will local site training take place?
A: Sites are responsible for training their teams. Online resources, in-service slides, and study materials will be provided.