Linked Life Data

15213636

Source:http://linkedlifedata.com/resource/pubmed/id/15213636

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
2-3 Pt 1
pubmed:dateCreated
2004-6-23
pubmed:abstractText
The aim of this study was to assess the safety and efficacy of intravenous (IV) injections of gacyclidine, a novel NMDA receptor antagonist, for neurological and functional recovery following acute traumatic brain injury. This multicenter, prospective, randomized, placebo-controlled, double-blind study compared four parallel groups. Two IV doses were administrated (placebo, 2x0.005mg/kg, 2x0.001mg/kg, 2x0.02mg/kg): the first dose was given within 2 hours following the trauma, and the second dose 4 hours after the first. Fifty-one patients were enrolled and 48 studied between March 1995 and June 1997 in France. Evaluation criteria for safety were physical examination, cardiovascular parameters, blood chemistry, hematology, ECG, and neuropsychological changes monitored after medication. Primary evaluation criteria for efficacy was the Glasgow coma scale complemented by the initial CT-scan and Glasgow outcome scale, motor deficiencies, neuropsychological changes, and functional indenpendence at D90 and D365 or endpoint. Intracranial pressure (ICP) monitoring was not taken into account because all the clinical centers participating in this study did not use this technique in daily practice during the inclusion period. Twelve patients died during the follow-up period, none of these deaths being related to the drug. Serious adverse events (181) were reported by most of the patients with no significant differences between groups. Only 10 of these adverse events were considered to be drug-related. Safety-related laboratory tests did not show any relevant changes. Concerning efficacy, the predefined prognostic factors (initial CT-scan score, initial Glasgow Coma Scale and occurrence of low systolic blood pressure during the first 24 hours) largely determinated the patient's outcome. When the prognostic factors were taken into account together with the dose level in a logistic regression model, gacyclidine showed a beneficial long-term effect and a best dose-result in the 0.04mg/kg treated group. Data obtained in this clinical trial appeared sufficient to warrant a European multicenter study on gacyclidine using the same evaluation criteria and ICP monitoring.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Jun
pubmed:issn
0028-3770
pubmed:author
pubmed:issnType
Print
pubmed:volume
50
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
83-95
pubmed:dateRevised
2006-11-15
pubmed:meshHeading
pubmed-meshheading:15213636-Adolescent, pubmed-meshheading:15213636-Adult, pubmed-meshheading:15213636-Aged, pubmed-meshheading:15213636-Blood Pressure, pubmed-meshheading:15213636-Brain Injuries, pubmed-meshheading:15213636-Cyclohexanes, pubmed-meshheading:15213636-Cyclohexenes, pubmed-meshheading:15213636-Double-Blind Method, pubmed-meshheading:15213636-Electrocardiography, pubmed-meshheading:15213636-Endpoint Determination, pubmed-meshheading:15213636-Female, pubmed-meshheading:15213636-Glasgow Coma Scale, pubmed-meshheading:15213636-Humans, pubmed-meshheading:15213636-Intracranial Pressure, pubmed-meshheading:15213636-Male, pubmed-meshheading:15213636-Middle Aged, pubmed-meshheading:15213636-Neuroprotective Agents, pubmed-meshheading:15213636-Neuropsychological Tests, pubmed-meshheading:15213636-Physical Examination, pubmed-meshheading:15213636-Pilot Projects, pubmed-meshheading:15213636-Piperidines, pubmed-meshheading:15213636-Prospective Studies, pubmed-meshheading:15213636-Tomography, X-Ray Computed, pubmed-meshheading:15213636-Treatment Outcome
pubmed:year
2004
pubmed:articleTitle
Neuroprotective effect of gacyclidine. A multicenter double-blind pilot trial in patients with acute traumatic brain injury.
pubmed:affiliation
Service de Neurochirurgie, CHU de Bicêtre, AP-HP, 78, rue du Général-Leclerc, 94275 Le Kremlin-Bicêtre Cedex, France. jf.lepeintre@bct.ap-hop-paris.fr
pubmed:publicationType
Journal Article, Clinical Trial, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Multicenter Study