NCT04303065 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Lara M, Moll A, Mas A, Picado MJ, Gassent C, Pomar J, Llompart-Pou JA, Brell M, Ibáñez J, Pérez-Bárcena J
Use of diffusion tensor imaging to assess the vasogenic edema in traumatic pericontusional tissue. Neurocirugia (Astur). 2020 Jul 21. pii: S1130-1473(20)30080-4. doi: 10.1016/j.neucir.2020.05.002. [Epub ahead of print] English, Spanish.
Moll A, Lara M, Pomar J, Orozco M, Frontera G, Llompart-Pou JA, Moratinos L, González V, Ibáñez J, Pérez-Bárcena J
Effects of dexamethasone in traumatic brain injury patients with pericontusional vasogenic edema: A prospective-observational DTI-MRI study. Medicine (Baltimore). 2020 Oct 23;99(43):e22879. doi: 10.1097/MD.0000000000022879.

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.

Details for clinical trial NCT04303065

Clinical trial NCT04303065 - References