administration of protein C in patients with severe sepsis.

• Conditions: patients affected by severe sepsis admitted to intensive care; MedDRA version: 14.1Level: PTClassification code 10040047Term: SepsisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2011-004834-32-IT
• Lead Sponsor: FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-08
• Last Update Posted: 2 October 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

age > 18 years; extracorporeal membrane oxygenation (ECMO) veno-venous; acute respiratory distress syndrome (ARDS)with sepsis; disseminated intravascular coagulation (DIC) sepsis based; organ dysfunction induced by sepsis associated with a clinical assessment of high risk of death
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

previous abnormal reactions to any component or PC; PC administration or inclusion in other randomized protocols in the previous 30 days; 24 hours expectation of death; cardiogenic shock refractory; pregnant women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to confirm the beneficial effects of the use of protein C concentrate;Secondary Objective: to confirm that any possible bleeding is not related to the use of protein C;Primary end point(s): mortality to 30 days and / or prolonged stay in intensive care (more than 30 days after randomization) in patients with severe sepsis from 75% to 50%;Timepoint(s) of evaluation of this end point: 30 days and 1 year follow-up by telephone call

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): time of mechanical ventilation, time of hospital stay, thrombo embolic events (ie: microvascular dysfunction, organ, amputation, stroke, proved thrombosis, inflammatory and coagulation values such as IL6, IL10, IL18, ATIII, TAT, F1 + F2, FG, APC, D-dimer and platelets count);Timepoint(s) of evaluation of this end point: 30 days and 1 year follow-up by telephone call