About: The BRAIN TRIAL: a randomised, placebo controlled trial of a Bradykinin B2 receptor antagonist (Anatibant) in patients with traumatic brain injury     Goto   Sponge   NotDistinct   Permalink

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  • Cerebral oedema is associated with significant neurological damage in patients with traumatic brain injury. Bradykinin is an inflammatory mediator that may contribute to cerebral oedema by increasing the permeability of the blood-brain barrier. We evaluated the safety and effectiveness of the non-peptide bradykinin B2 receptor antagonist Anatibant in the treatment of patients with traumatic brain injury. During the course of the trial, funding was withdrawn by the sponsor. CONCLUSION: This trial did not reach the planned sample size of 400 patients and consequently, the study power to detect an increase in the risk of serious adverse events was reduced. This trial provides no reliable evidence of benefit or harm and a larger trial would be needed to establish safety and effectiveness.
  • Cerebral oedema is associated with significant neurological damage in patients with traumatic brain injury. Bradykinin is an inflammatory mediator that may contribute to cerebral oedema by increasing the permeability of the blood-brain barrier. We evaluated the safety and effectiveness of the non-peptide bradykinin B2 receptor antagonist Anatibant in the treatment of patients with traumatic brain injury. During the course of the trial, funding was withdrawn by the sponsor. CONCLUSION: This trial did not reach the planned sample size of 400 patients and consequently, the study power to detect an increase in the risk of serious adverse events was reduced. This trial provides no reliable evidence of benefit or harm and a larger trial would be needed to establish safety and effectiveness. (en)
Title
  • The BRAIN TRIAL: a randomised, placebo controlled trial of a Bradykinin B2 receptor antagonist (Anatibant) in patients with traumatic brain injury
  • The BRAIN TRIAL: a randomised, placebo controlled trial of a Bradykinin B2 receptor antagonist (Anatibant) in patients with traumatic brain injury (en)
skos:prefLabel
  • The BRAIN TRIAL: a randomised, placebo controlled trial of a Bradykinin B2 receptor antagonist (Anatibant) in patients with traumatic brain injury
  • The BRAIN TRIAL: a randomised, placebo controlled trial of a Bradykinin B2 receptor antagonist (Anatibant) in patients with traumatic brain injury (en)
skos:notation
  • RIV/00216208:11120/09:00002028!RIV10-MSM-11120___
http://linked.open...avai/riv/aktivita
http://linked.open...avai/riv/aktivity
  • S
http://linked.open...iv/cisloPeriodika
  • 109
http://linked.open...vai/riv/dodaniDat
http://linked.open...aciTvurceVysledku
http://linked.open.../riv/druhVysledku
http://linked.open...iv/duvernostUdaju
http://linked.open...titaPredkladatele
http://linked.open...dnocenehoVysledku
  • 305478
http://linked.open...ai/riv/idVysledku
  • RIV/00216208:11120/09:00002028
http://linked.open...riv/jazykVysledku
http://linked.open.../riv/klicovaSlova
  • Focal cerebral-ischemia; edema formation; tissue-damage (en)
http://linked.open.../riv/klicoveSlovo
http://linked.open...odStatuVydavatele
  • GB - Spojené království Velké Británie a Severního Irska
http://linked.open...ontrolniKodProRIV
  • [E89CA629ED11]
http://linked.open...i/riv/nazevZdroje
  • Trials
http://linked.open...in/vavai/riv/obor
http://linked.open...ichTvurcuVysledku
http://linked.open...cetTvurcuVysledku
http://linked.open...UplatneniVysledku
http://linked.open...v/svazekPeriodika
  • 10
http://linked.open...iv/tvurceVysledku
  • Svoboda, P.
  • Singh, M.
  • Pachl, Jan
  • Sampaio, C.
  • Shakur, H.
  • Andrews, P.
  • Asser, T.
  • Balica, L.
  • Boeriu, C.
  • Dewan, Y.
  • Druwé, P.
  • Fletcher, O.
  • Frost, C.
  • Hartzenberg, B.
  • Mantilla, J. M.
  • Murillo-Cabezas, F.
  • Quintero, J. D.
  • Ravi, R. R.
  • Roberts, I.
  • Rätsep, I.
http://linked.open...ain/vavai/riv/wos
  • 000272746800001
issn
  • 1745-6215
number of pages
http://localhost/t...ganizacniJednotka
  • 11120
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