Trial Status: completed
Start Date: 01 November 2006
End Date: 06 June 2008
Participants recruited to date: 228
Trial protocol: ISRCTN23625128
Trial Summary:
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.
Adults with traumatic brain injury and a Glasgow Coma Scale score of 12 or less, who had a CT scan showing an intracranial abnormality consistent with trauma, and were within eight hours of their injury were randomly allocated to low, medium or high dose Anatibant or to placebo. Outcomes were Serious Adverse Events (SAE), mortality 15 days following injury and in-hospital morbidity assessed by the Glasgow Coma Scale (GCS), the Disability Rating Scale (DRS) and a modified version of the Oxford Handicap Scale (HIREOS).
During the course of the trial, funding was withdrawn by the sponsor.
Publications:
Haleema Shakur, Peter Andrews, Toomas Asser, Laura Balica, Cristian Boeriu, Juan Diego Ciro Quintero, Yashbir Dewan, Patrick Druwe, Olivia Fletcher, Chris Frost, Bennie Hartzenberg, Jorge Mejia Mantilla, Francisco Murillo-Cabezas, Jan Pachl, Ramalingam R Ravi, Indrek Ratsep, Cristina Sampaio, Manmohan Singh, Petr Svoboda, Ian Roberts
Trials 2009, 10:109 (3 December 2009)
Responses:
Vincent F Simmon – Trials 2009, 10:110 (3 December 2009)
Ian Roberts, Haleema Shakur-Still – Trials 2009, 10:110 (3 December 2009)