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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
The BRAIN TRIAL: A randomised, placebo controlled trial of a Bradykinin B2 receptor antagonist (Anatibant) in patients with traumatic brain injury
Trials, Volume 10, Article 109, Year 2009
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Description
Background: 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 During the course of the trial, funding was withdrawn by the sponsor. Methods: 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). Results: 228 patients out of a planned sample size of 400 patients were randomised. The risk of experiencing one or more SAEs was 26.4% (43/163) in the combined Anatibant treated group, compared to 19.3% (11/57) in the placebo group (relative risk = 1.37; 95% CI 0·76 to 2·46). All cause mortality in the Anatibant treated group was 19% and in the placebo group 15.8% (relative risk 1.20, 95% CI 0.61 to 2.36). The mean GCS at discharge was 12.48 in the Anatibant treated group and 13.0 in the placebo group. Mean DRS was 11.18 Anatibant versus 9.73 placebo, and mean HIREOS was 3.94 Anatibant versus 3.54 placebo. The differences between the mean levels for GCS, DRS and HIREOS in the Anatibant and placebo groups, when adjusted for baseline GCS, showed a non-significant trend for worse outcomes in all three measures. 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. © 2009 Shakur et al; licensee BioMed Central Ltd.
Authors & Co-Authors
Shakur-Still, Haleema
Unknown Affiliation
Andrews, Peter
Unknown Affiliation
Asser, Toomas
Unknown Affiliation
Balica, Laura
Unknown Affiliation
Boeriu, Cristian
Unknown Affiliation
Quintero, Juan D.C.
Unknown Affiliation
Dewan, Yashbir
Unknown Affiliation
Druwé, Patrick M.
Unknown Affiliation
Fletcher, Olivia
Unknown Affiliation
Frost, Chris D.
Unknown Affiliation
Hartzenberg, Bennie H.
Unknown Affiliation
Mantilla, Jorge M.
Unknown Affiliation
Murillo-Cabezas, Francisco
Unknown Affiliation
Pachl, Jan
Unknown Affiliation
Ravi, Ramalingam R.
Unknown Affiliation
Rätsep, Indrek
Unknown Affiliation
Sampaio, Cristina R.
Unknown Affiliation
Singh, Manmohan Jit
Unknown Affiliation
Svoboda, Petr
Unknown Affiliation
Roberts, Ian G.
Unknown Affiliation
Statistics
Citations: 53
Authors: 20
Affiliations: 19
Identifiers
Doi:
10.1186/1745-6215-10-109
ISSN:
17456215
e-ISSN:
17456215
Research Areas
Disability
Health System And Policy
Violence And Injury