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

Trials

Volumn 10, Issue , 2009, Pages

  Shakur, Haleema ^a   Andrews, Peter ^b   Asser, Toomas ^c   Balica, Laura ^d   Boeriu, Cristian ^e   Quintero, Juan D C ^f,g   Dewan, Yashbir ^h   Druwé, Patrick ⁱ   Fletcher, Olivia ^a   Frost, Chris ^a   Hartzenberg, Bennie ^j   Mantilla, Jorge M ^k   Murillo Cabezas, Francisco ^l   Pachl, Jan ^m   Ravi, Ramalingam R ⁿ   Rätsep, Indrek ^o   Sampaio, Cristina ^p   Singh, Manmohan ^q   Svoboda, Petr ^r   Roberts, Ian ^a  

^a LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

^b UNIVERSITY OF EDINBURGH   (United Kingdom)

^c UNIVERSITY OF TARTU   (Estonia)

^d Spitalul Clinic de Urgen Bucure ti   (Romania)

^e Mobile Emergency Service   (Romania)

^f Clinica Las Americas   (Colombia)

^g Epilepsy Section   (Colombia)

^h CHRISTIAN MEDICAL COLLEGE   (India)

ⁱ Sint Vincentiushospital ^*  (Belgium)

^j STELLENBOSCH UNIVERSITY   (South Africa)

^k FUNDACIÓN VALLE DEL LILI   (Colombia)

^l HOSPITAL UNIVERSITARIO VIRGEN DEL ROCÍO   (Spain)

^m CHARLES UNIVERSITY   (Czech Republic)

ⁿ Medical Trust Hospital   (India)

^o North Estonian Regional Hospital   (Estonia)

^p HOSPITAL DE SANTA MARIA   (Portugal)

^q ALL INDIA INSTITUTE OF MEDICAL SCIENCES   (India)

^r Research Inst Traumatology Surgery   (Czech Republic)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANATIBANT; PLACEBO; AUTACOID; BRADYKININ B2 RECEPTOR; QUINOLINE DERIVATIVE;

ADOLESCENT; ADULT; ARTICLE; CLINICAL TRIAL; COMPUTER ASSISTED TOMOGRAPHY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISABILITY RATING SCALE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG MEGADOSE; DRUG SAFETY; FEMALE; GLASGOW COMA SCALE; HOSPITALIZATION; HUMAN; INJECTION SITE ERYTHEMA; LOADING DRUG DOSE; LOW DRUG DOSE; MAINTENANCE THERAPY; MAJOR CLINICAL STUDY; MALE; MORBIDITY; MORTALITY; OUTCOME ASSESSMENT; OXFORD HANDICAP SCALE; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; THERAPY EFFECT; TRAUMATIC BRAIN INJURY; BRAIN INJURY; COMPARATIVE STUDY; DRUG ANTAGONISM; IMMUNOLOGY; PLACEBO EFFECT; RISK FACTOR;

ADULT; BRAIN INJURIES; GLASGOW COMA SCALE; HUMANS; INFLAMMATION MEDIATORS; MORBIDITY; PLACEBO EFFECT; QUINOLINES; RECEPTOR, BRADYKININ B2; RISK FACTORS;

EID: 72549108527     PISSN: 17456215     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-10-109     Document Type: Article

References (16)

1. Marmarou A, Fatouros PP, Barzó P, Portella G, Yoshihara M, Tsuji O, Yamamoto T, Laine F, Signoretti S, Ward JD, Bullock MR, Young HF. Contribution of edema and cerebral blood volume to traumatic brain swelling in head-injured patients. J Neurosurg 2000, 93(2):183-93. Erratum in: J Neurosurg 2001, 94(2):349, 10.3171/jns.2000.93.2.0183, 10930002.
2. Schilling L, Wahl M. Brain edema: pathogenesis and therapy. Kidney Int Suppl 1997, 59:S69-75.
3. Wahl M, Whalley ET, Unterberg A, Schilling L, Parsons AA, Baethmann A, Young AR. Vasomotor and permeability effects of bradykinin in the cerebral microcirculation. Immunopharmacology 1996, 33(1-3):257-63. 10.1016/0162-3109(96)00068-9, 8856159.
4. Marmarou A, Guy M, Murphey L, Roy F, Layani L, Combal JP. A single dose, three-arm, placebo-controlled, phase I study of the bradykinin B2 receptor antagonist Anatibant (LF16-0687Ms) in patients with severe traumatic brain injury. Journal of Neurotrauma 2005, 22(12):1444-55. 10.1089/neu.2005.22.1444, 16379582.
5. Maas AIR, Schouten JW, Teasdale GM. Neuroprotection in traumatic brain injury. IN: Head Injury - Pathophysiology and Management. 2005, 406-440. Hodder Arnold: London, UK, Reilly PL, Bullock R, 2, ISBN: 0340-80724-5.
6. Ker K, Perel P, Blackhall K. Beta-2 receptor antagonists for traumatic brain injury: a systematic review of controlled trials in animal models. CNS Neuroscience and Therapeutics 2009, 15(1):52-64.
7. Ker K, Blackhall K. Beta-2 receptor antagonists for acute traumatic brain injury. Cochrane Database of Systematic Reviews 2008, (1).
8. Zausinger S, Lumenta DB, Pruneau D, Schmid-Elsaesser R, Plesnila N, Baethmann A. Effects of LF 16-0687 Ms, a bradykinin B(2) receptor antagonist, on brain edema formation and tissue damage in a rat model of temporary focal cerebral ischemia. Brain Res 2002, 20;950(1-2):268-78.
9. Kaplanski J, Pruneau D, Asa I, Artru AA, Azez A, Ivashkova Y, Rudich Z, Shapira Y. LF 16-0687 Ms, a bradykinin B2 receptor antagonist, reduces brain edema and improves long-term neurological function recovery after closed head trauma in rats. J Neurotrauma 2002, 19(8):953-64. 10.1089/089771502320317104, 12225655.
10. Zausinger S, Lumenta DB, Pruneau D, Schmid-Elsaesser R, Plesnila N, Baethmann A. Therapeutic efficacy of a novel non-peptide bradykinin B2 receptor antagonist on brain edema formation and ischemic tissue damage in focal cerebral ischemia. Acta Neurochir Suppl 2003, 86:205-7.
11. Ding-Zhou L, Margaill I, Palmier B Pruneau D, Plotkine M, Marchand-Verecchia C. LF 16-0687 Ms, a bradykinin B2 receptor antagonist, reduces ischemic brain injury in a murine model of transtient focal cerebral ischemia. Br J Pharmacol 2003, 139(8):1539-47. 10.1038/sj.bjp.0705385, 1573979, 12922942.
12. XY2405, Bradykinin B2 Receptor Antagonist, INVESTIGATOR'S BROCHURE, VERSION 2.0, Release Date: 10 August 2006 (Xytis Pharmaceuticals).
13. Efron B, Tibshirani RJ. An introduction to the Bootstrap. 1993, Chapman and Hall/CRC.
14. ICH Harmonised Tripartite Guideline for Good Clinical Practice. 1996, , http://www.ich.org/LOB/media/MEDIA482.pdf
15. Cook D, Lauzier F, Rocha M MG, Sayles MJ, Finfer S. Serious adverse events in academic critical care research. CMAJ 2008, 178(9):1181-1184. 2292790, 18427095.
16. Vincent J-L, . for the ENHANCE Study Group Drotrecogin alfa (activated) treatment in severe sepsis from the global open-label trial ENHANCE: Further evidence for survival and safety and implications for early treatment. Crit Care Med 2005, 33(10):2266-2277. 10.1097/01.CCM.0000181729.46010.83, 16215381.