Pérez-Bárcena, JonCastano-Leon, Ana MariaLagares Gomez-Abascal, AlfonsoBarea-Mendoza, Jesus AbelardoNavarro Main, BlancaPomar Pons, JaumePeriáñez Párraga, LeonorIbáñez Domínguez, Javier AngelChico-Fernandez, MarioLlompart-Pou, Juan AntonioFrontera-Juan, GuillemDEXCON TBI Trial Collaborators2024-09-182024-09-182021-01-22Perez-Barcena J, Castano-Leon AM, Gomez-Abascal AL, Barea-Mendoza JA, Main BN, Pons JP, et al. 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. Medicine (Baltimore). 2021 Jan 22;100(3):e24206.0025-7974https://hdl.handle.net/20.500.13003/19538https://hdl.handle.net/20.500.12105/23226Background: 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.enghttp://creativecommons.org/licenses/by/4.0/Brain contusionsDexamethasonePericontusional edemaTraumatic brain injuryRandomized Controlled Trials as TopicProspective StudiesOutcome Assessment, Health CareBrain EdemaHumansBrain ContusionAnti-Inflammatory AgentsDexamethasoneDouble-Blind Methodresearch articleAttribution 4.0 International335460381003e2420610.1097/MD.00000000000242061536-5964Medicineopen accessMétodo Doble CiegoDexametasonaContusión EncefálicaEdema EncefálicoAntiinflamatoriosHumanosEstudios ProspectivosEvaluación de Resultado en la Atención de SaludEnsayos Clínicos Controlados Aleatorios como Asunto2-s2.0-85102089354612835100118L634212570