Repertaxin in Prevention of Primary Graft Dysfunction After Lung Transplantation

PHASE2CompletedINTERVENTIONAL
Enrollment

114

Participants

Timeline

Start Date

May 1, 2005

Primary Completion Date

September 13, 2006

Study Completion Date

September 13, 2007

Conditions
Ischemia-Reperfusion InjuryLung Transplantation
Interventions
DRUG

Repertaxin

An initial 'loading dose' of repertaxin was administered over 30 minutes by intravenous infusion followed by a maintenance dose lasting 47.5 hours.The infusion was to start approximately 2 hours prior to the anticipated time of reperfusion and was to continue during the ICU/hospital stay. The study medication was administered as a continuous intravenous infusion into a (high flow) central vein, by an infusion pump adequate to provide reliable infusion rates , as per treatment schedule. Total infusion volume was not to exceed 500 mL/24 hours.

OTHER

Placebo

An initial 'loading dose' of placebo was administered over 30 minutes by intravenous infusion followed by a maintenance dose lasting 47.5 hours.The infusion was to start approximately 2 hours prior to the anticipated time of reperfusion and was to continue during the ICU/hospital stay. The placebo was administered as a continuous intravenous infusion into a (high flow) central vein, by an infusion pump adequate to provide reliable infusion rates , as per treatment schedule. Total infusion volume was not to exceed 500 mL/24 hours.

Trial Locations (6)

27710

Duke University Medical Center, Durham

44195

The Cleveland Clinic Foundation, Cleveland

63110

Washington University School of Medicine, St Louis

80262

University of Colorado, Health Sciences Centre, Denver

90033

University of South California, Department of Cardiothoracic Surgery, Los Angeles

M5G2C4

Toronto General Hospital, Toronto

All Listed Sponsors
lead

Dompé Farmaceutici S.p.A

INDUSTRY

NCT00224406 - Repertaxin in Prevention of Primary Graft Dysfunction After Lung Transplantation | Biotech Hunter | Biotech Hunter