KARE

Trial Acronym	KARE
Clinical Area	Critical Care
Description	Keratinocyte growth factor in Acute lung injury to REduce pulmonary dysfunction – a randomised placebo controlled trial (KARE).
Status	Closed

RECRUITMENT

Date Opened to Recruitment	February 2011
Target Recruitment	60
Recruitment to date	60
Date Opened to Recruitment	31 December 2013

TRIAL DESIGN

Trial Design	Prospective, randomised, double-blind, placebo-controlled phase 2 , clinical study of palifermin in patients with ALI.
Study Aim	The hypothesis is that treatment with palifermin will improve surrogate clinical outcomes in adult patients with ALI and is safe.The objectives of the trials are:
	1) To conduct a randomised, double-blind, placebo-controlled phase 2 trial of palifermin for the treatment of ALI
	2) To study the biological mechanisms of palifermin on pulmonary and systemic neutrophil function and inflammation; alveolar epithelial and endothelial function protease:antiprotease balance and lung extracellular matrix degradation and turnover

CHIEF INVESTIGATOR (CI)

Chief Investigator

Professor Danny McAuley

SPONSOR(s) & FUNDER(s)

Sponsor	Belfast Health and Social Care Trust
Funder	Public Health Agency, Health and Social Care, Research and Development