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Table 3 Nine PRECIS-2 domains for trial designing characteristics

From: Evaluation of the effects of pycnogenol (French maritime pine bark extract) supplementation on inflammatory biomarkers and nutritional and clinical status in traumatic brain injury patients in an intensive care unit: A randomized clinical trial protocol

Domain Considerations
Eligibility All eligible TBI a patients admitted directly or transferred to the ICU b of participating hospital will take PYC c along with their routine treatment
Recruitment path Pragmatic recruitment through usual visit of patients in ICU
Setting All tests and evaluation status of patients in this trials are performed routinely as a part of usual care, except specialized test including: IL-6 d, IL-1β e, MDA f, and TAC g
Organization ICU that has intensivist and its trained stuff
Flexibility in delivery PYC will be prescribed with gavage
Flexibility in adherence After the written consent of the patient or his/her companion, PYC will be prescribed by the intensivist and will be gavaged by the nurse. PYC is a dietary supplement and it does not interfere with other medications and will be given as part of the patient’s nutritional formula
Follow-up Usual follow-up that is performed for critically ill patients will be done in this trial; also, a 28-day follow-up for mortality will be performed
Primary outcome All outcome directly are related to clinical status of patients
Primary analysis Intention-to-treat with all available data will be used for analysis
  1. a Traumatic brain injury. b Intensive care unit. c Pycnogenol. d Interleukin-6. e Interleukin-1β. f Malondialdehyde. g Total antioxidant capacity