Traumatic Brain Injury Clinical Trial
Official title:
Evaluation the Effects of French Maritime Pine Bark Extract Supplementation on the Inflammatory Biomarkers, Nutritional and Clinical Status in Traumatic Brain Injury Patients, in Intensive Care Unit; A Randomized Clinical Trial
Introduction: Traumatic brain injury (TBI) is one of the major health and socioeconomic
problems in the world. Immune-enhancing enteral formula has been proven to significantly
reduce infection rate in TBI patient. One of the ingredients that can be used in
immunonutrition formulas to reduce inflammation and oxidative stress is French maritime pine
bark extract.
Objective: The main objective of present study is surveying the effect of French maritime
pine bark extract on the clinical, nutritional and inflammatory status of TBI patients as the
first human study in the world.
Method: this is double-blind, randomized controlled trial. Block randomization are used.
Intervention group will receive French maritime pine bark extract supplement (OLIGOPIN) 150
mg for 10 days. Control group will receive placebo for the same duration. Inflammatory status
(IL-6, IL- 1β, C-reactive protein) and oxidative stress status (Malondialdehyde, total
antioxidant capacity), at the base line, at the 5th day and at the end of the study (10th
day) are measured. APACHE ІІ (acute physiologic and chronic health evaluation II) for
assessment of clinical status of patients and Nutric questionnaires for assessment of
nutritional status filled out at the base line, 5th day and the end of study. SOFA
(sequential organ failure assessment) questionnaire for assessment of organ failure filled
out every other day. The mortality rate will be asked by phone within 28 days of the start of
the intervention. Weight, body mass index and body composition at baseline, 5th day and 10th
day of intervention are measured. All analyses will be conducted by initially assigned study
arm in an intention-to-treat analysis. The data will be expressed as mean ± SD.
Randomization:
investigators randomly assign eligible patients on enrolment (1:1) to either the control
group or the intervention group. Randomization is stratified by site and a randomization list
of unique patient identifiers is generated by the study statistician using a
computer-generated random block size. The classification is based on age (18 to 40 and 40 to
65 years old), gender (male / female) and APACHEII score (0 to 35 and 35 to 71) using
quadruple blocks.
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