Ignite Creation Date:
2024-05-06 @ 2:24 PM
Last Modification Date:
2024-10-26 @ 1:30 PM
Study NCT ID:
NCT04303065
Status:
UNKNOWN
Last Update Posted:
2020-11-23
First Post:
2020-03-05
Brief Title:
Dexamethasone for the Treatment of Vasogenic Pericontusional Edema
Sponsor:
Hospital Son Espases
Organization:
Hospital Son Espases
Study Overview
Official Title:
Dexamethasone for the Treatment of Traumatic Brain Injured Patients With Brain Contusions and Pericontusional Edema Study Protocol for a Prospective Randomized and Double Blind Trial
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEXCON-TBI
Brief 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 4mg6 hours 2 days 4 mg8 hours 2 days 2 mg6 hours 2 days 2 mg8 hours 2 days 1 mg8 hours 2 days 1 mg12 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 alpha5 to detect a 12 absolute increased from 50 to 62 in good outcome
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None