NCT04675216 - 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)

Mizunari T
[Clinical aspects and intracranial pressure monitoring in cases of traumatic posterior fossa hematoma]. Nihon Ika Daigaku Zasshi. 1990 Aug;57(4):334-43. doi: 10.1272/jnms1923.57.334. Japanese.
Oshorov AV, Savin IA, Goriachev AS, Popugaev KA, Lubnin AIu
[Monitoring of intracranial pressure difference between supra- and infratentorial spaces after posterior fossa tumor removal (case report)]. Anesteziol Reanimatol. 2011 Jul-Aug;(4):74-7. Russian
Park CK
Accuracy of ICP monitoring in posterior fossa lesions. J Neurosurg. 1990 May;72(5):832-3. No abstract available.
Rieger A, Rainov NG, Sanchin L, Ebel H, Furka I, Gorombey Z, Burkert W
Is it useful to measure supratentorial ICP in the presence of a posterior fossa lesion? Absence of transtentorial pressure gradients in an animal model. Br J Neurosurg. 1999 Oct;13(5)
Rooker S, De Visscher G, Van Deuren B, Borgers M, Jorens PG, Reneman RS, van Rossem K, Verlooy J
Comparison of intracranial pressure measured in the cerebral cortex and the cerebellum of the rat. J Neurosci Methods. 2002 Sep 15;119(1):83-8. doi: 10.1016/
Rosenwasser RH, Kleiner LI, Krzeminski JP, Buchheit WA
Intracranial pressure monitoring in the posterior fossa: a preliminary report. J Neurosurg. 1989 Oct;71(4):503-5. doi: 10.3171/jns.1989.71.4.0503.
Slavin KV, Misra M
Infratentorial intracranial pressure monitoring in neurosurgical intensive care unit. Neurol Res. 2003 Dec;25(8):880-4. doi: 10.1179/016164103771954014.
Wolfla CE, Luerssen TG, Bowman RM, Putty TK
Brain tissue pressure gradients created by expanding frontal epidural mass lesion. J Neurosurg. 1996 Apr;84(4):642-7. doi: 10.3171/jns.1996.84.4.0642.

Posterior Fossa Intracranial Pressure (ICP) Measurement in Cases of Traumatic, Ischemic, or Tumor Pathology (Post-surgical) at This Level: Clinical Study

Details for clinical trial NCT04675216

Clinical trial NCT04675216 - References