Treatment with the platelet-activating factor antagonist TCV-309 in patients with severe systemic inflammatory response syndrome: a prospective, multi-center, double-blind, randomized phase II trial.

A.H. Froon, J.W.M. Greve, W.A. Buurman, C.J. van der Linden, H.J.M. Langemeijer, C. Ulrich, M. Bourgeois

Research output: Contribution to journalArticleAcademicpeer-review

27 Citations (Scopus)

Abstract

Treatment with the platelet-activating factor antagonist TCV-309 in patients with severe systemic inflammatory response syndrome: a prospective, multi-center, double-blind, randomized phase II trial.

Froon AM, Greve JW, Buurman WA, van der Linden CJ, Langemeijer HJ, Ulrich C, Bourgeois M.

Academic Hospital Maastricht, The Netherlands.

In a prospective randomized, double-blind, placebo-controlled clinical study, the safety and efficacy of the platelet-activating factor antagonist TCV-309 in the treatment of systemic inflammatory response syndrome was studied. In total 29 patients were treated with 1.0 mg/kg TCV-309 twice daily during 7 days or with placebo. Study parameters were as follows: adverse events, 28 and 56 day all cause mortality, multi-organ failure scores, and the inflammatory mediators tumor necrosis factor, interleukin 6, interleukin 8, and soluble E-selectin. There was no difference in number and severity of adverse events between TCV-309- and placebo-treated patients. Day 28 and day 56 mortality was similar in both groups (day 56: 7/12 TCV-309 vs. 9/16 placebo, NS). Pulmonary and hematological failure scores improved significantly in TCV-309-treated patients (p < .05). There was no difference in inflammatory mediator levels between TCV-309- and placebo-treated patients. Treatment with TCV-309 appears to be safe in patients with systemic inflammatory response syndrome and does improve organ failure significantly.

Publication Types:
Clinical Trial
Clinical Trial, Phase II
Multicenter Study
Randomized Controlled Trial
Original languageEnglish
Pages (from-to)313-319
JournalShock
Volume5
DOIs
Publication statusPublished - 1 Jan 1996

Cite this