Dexamethasone for the Treatment of Vasogenic Pericontusional Edema.
Status:
Recruiting
Trial end date:
2024-02-01
Target enrollment:
Participant gender:
Summary
The DEXCON-TBI trial is a multicenter, pragmatic, randomized, triple-blind, placebo
controlled trial to quantify the effects of the administration of dexamethasone on the
prognosis of TBI patients with brain contusions and pericontusional edema. Adult patients who
fulfil the elegibility criteria will be randomized to receive dexamethasone or placebo.
Patients who have suffered a head injury and have one or more cerebral contusions with
visible pericontusional edema in the CT scan can be included in the study. The doses of
dexamethasone will be a short and descending course: 4mg/6 hours (2 days); 4 mg/8 hours (2
days); 2 mg/6 hours (2 days); 2 mg/8 hours (2 days); 1 mg/8 hours (2 days); 1 mg/12 hours (2
days). The primary outcome is the Glasgow Scale Outcome Extended (GOSE) performed one month
and 6 months after trauma. Other secondary outcomes are: compare the number of episodes of
neurological deterioration; compare the symptoms associated with TBI; compare the presence of
adverse events during treatment; compare the volume of pericontusional edema before and after
12 days of treatment in both groups of patients; and compare the results of the
neuropsychological tests between the two groups of patients one month and 6 months after the
TBI. The main analysis will be on an ''intention-to-treat´´ basis. A descriptive analysis of
the baseline variables will be made for each treatment group. Logistic regression will be
used to estimate the effect of dexamethasone and placebo on GOSE at one month and at 6
months, dichotomized in unfavorable outcome (GOSE 1-6) and favorable outcome (GOSE 7-8).
Since the severity of the initial injury will determine significantly the final outcome of
the patient, to assess the effect of dexamethasone, efficacy will also be analyzed using the
'sliding dichotomy'. A subgroup analysis will be carried out by stratifying the patients as
they present more or less than 10mL of pericontusional edema in the preinclusion CT. We will
perform an interim analysis with the patients included during the first year to calculate the
conditional power. An independent statistician will blindly perform this analysis. At the
same time a safety analysis will be also perfomed. A study with 600 patients would have about
80% power (two sided alpha=5%) to detect a 12% absolute increased (from 50% to 62%) in good
outcome.