The effect of administering high doses of intravenous vitamin C in severe traumatic brain injuries

Determining the effect of administering a high dose of intravenous vitamin C on the outcome of severe traumatic brain injuries

The clinical trial has a control group, with parallel groups, randomized, phase 3, the number of samples in each group is estimated to be 59, which, by including 15% drop during the study, the number of samples for each group is 69. Allocation of samples to intervention groups with using method Random blocks of 4 are done

This study is conducted on patients with severe brain damage and low level of consciousness who need to be hospitalized in ICU according to the order of a specialist doctor. Samples are collected from patients referred to the Trauma Referral Center of Shahid Rajaei Hospital in Qazvin Province Group A: Standard treatment along with daily 100 (mg/kg/day) vitamin C in 500 cc of normal saline divided into 3 doses for 3 days as intravenous injection and after 3 days, 3 grams of vitamin C daily in 500 cc of normal saline divided into 3 doses for one week is given to the patient. Group B: standard treatment

Inclusion criteria: patient age between 27 and 12 years, patients with brain damage severe (GCS ≤ 8), patients who have not undergone surgery, informed consent of the first degree relatives of the patients Exclusion criteria: end stage renal diseases, hemochromatosis patients, chronic liver diseases, chronic kidney diseases, history of kidney stones, Allergy to vitamin C, pregnancy and breastfeeding.

Group A: standard treatment plus vitamin C Group B: standard treatment Standard treatment includes head positioning, narcotic pain treatment, magnesium hydroxide for gastrointestinal function, heparin therapy, ulcer prophylaxis, and normal saline

Changes in the patient's clinical status and consciousness based on the GCS scale

All patients diagnosed with brain damage need to be hospitalized in ICU are the statistical population of this study. Patients were randomly assigned to one of the two treatment groups A (standard treatment plus vitamin C) or group B (standard treatment) are assigned. Sampling is done using the available method. Allocating the samples to the intervention groups using the method of 4 random blocks with the Block Balanced Randomization method in the form of AABB, ABBA, ABAB, BBAA, BAAB, BABA blocks will be placed together based on the table of random numbers.