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
| Autor: | Guillem Frontera Juan, Blanca Navarro Maín, Mario Chico-Fernández, Jesús Abelardo Barea-Mendoza, Ana M. Castaño-Leon, Alfonso Lagares Gómez-Abascal, Juan Antonio Llompart-Pou, Jon Pérez-Bárcena, Jaume Pomar Pons, Javier Ibáñez Domínguez, Leonor Del Mar Periañez Párraga |
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| Rok vydání: | 2020 |
| Předmět: |
Traumatic brain injury
brain contusions Placebo-controlled study Anti-Inflammatory Agents Brain Edema dexamethasone Placebo 03 medical and health sciences 0302 clinical medicine Double-Blind Method Study Protocol Clinical Trial Edema Outcome Assessment Health Care medicine Humans 030212 general & internal medicine Prospective Studies Adverse effect Prospective cohort study Dexamethasone Randomized Controlled Trials as Topic business.industry traumatic brain injury Glasgow Coma Scale Brain Contusion General Medicine medicine.disease 030220 oncology & carcinogenesis Anesthesia ComputingMethodologies_DOCUMENTANDTEXTPROCESSING pericontusional edema medicine.symptom business medicine.drug Research Article |
| Zdroj: | Medicine |
| ISSN: | 1536-5964 |
| Popis: | Supplemental Digital Content is available in the text Background: Traumatic brain injury (TBI) constitutes a leading cause of death and disability. Patients with TBI and cerebral contusions developing pericontusional edema are occasionally given dexamethasone on the belief that this edema is similar to that of tumors, in which the beneficial effect of dexamethasone has been demonstrated. Methods: The DEXCON TBI trial is a multicenter, pragmatic, randomized, triple-blind, placebo controlled trial to quantify the effects of dexamethasone on the prognosis of TBI patients with brain contusions and pericontusional edema. Adult patients who fulfill the elegibility criteria will be randomized to dexamethasone/placebo in a short and descending course: 4 mg/6 h (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 1 month and 6 months after TBI. Secondary outcomes are: number of episodes of neurological deterioration; symptoms associated with TBI; adverse events; volume of pericontusional edema before and after 12 days of treatment; results of the neuropsychological tests one month and 6 months after TBI. The main analysis will be on an “intention-to-treat” basis. Logistic regression will estimate the effect of dexamethasone/placebo on GOSE at one month and at 6 months, dichotomized in unfavorable outcome (GOSE 1–6) and favorable outcome (GOSE 7–8). Efficacy will also be analyzed using the 'sliding dichotomy’. An interim and safety analysis will be performed including patients recruited during the first year to calculate the conditional power. A study with 600 patients would have 80% power (2 sided alpha = 5%) to detect a 12% absolute increase (from 50% to 62%) in good recovery. Discussion: This is a confirmative trial to elucidate the therapeutic efficacy of dexamethasone in a very specific group of TBI patients: patients with brain contusions and pericontusional edema. This trial could become an important milestone for TBI patients as nowadays there is no effective treatment in this type of patients. Trial Registration: eudraCT: 2019–004038–41; Clinical Trials.gov: NCT04303065. |
| Databáze: | OpenAIRE |
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