Administration of Protein C Concentrates in Adult Critically Ill Septic Patients

Sepsis Clinical Trial

Official title:

Administration of Protein C Concentrates in Adult Critically Ill Septic Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01705808
• Other study ID #: OSR/40/04/12
• Status: Terminated
• Phase: Phase 3
• First received: July 25, 2012
• Last updated: December 14, 2015
• Start date: September 2012
• Est. completion date: October 2014

Study information

• Verified date: December 2015
• Source: Università Vita-Salute San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Severe sepsis and septic shock are life threatening medical emergencies and are among the most significant challenges in critical care. Case reports and case series suggest that plasma-derived protein C concentrate may improve the outcome of patients with acquired protein C deficiency. Evidence has accumulated on the clinical relevance of the PC pathway in modulating overwhelming inflammation and preventing coagulation derangements, two key mediators of organ damage, and thus of mortality and morbidity, in sepsis. The experience collected through these studies shows that PC is safe, in that it is not associated with bleeding or severe allergic complications,and possibly useful, at least to improve the coagulation abnormalities brought about by sepsis. Unfortunately, however, all we know comes from case series or case reports or an underpowered randomized controlled study. A randomized clinical trial, adequately powered for mortality or clinically relevant outcome, is necessary to confirm PC efficacy.The aim of this study is to demonstrate that Protein C zymogen has clinically relevant implications in terms of reduction of thromboembolic events, 30 days mortality, length of intensive care and hospital stay, time on mechanical ventilation, length of ICU and hospital stay. The study will also confirm that there is no bleeding concern with the use of Protein C concentrates.The study drug will be administered in the Intensive Care Unit for 72 hours and the patients observed till ICU discharge. Telephone followup will be performed at 30 days and at one year.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: October 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Written informed consent

• Age > 18 years

• At least one of the following 3 criteria:

• venous-venous extra corporeal membrane oxygenation (ECMO) for septic adult respiratory distress syndrome (ARDS)

• septic disseminated intravascular coagulopathy (DIC)

• sepsis induced organ dysfunction associated with a clinical assessment of high risk of death

Exclusion Criteria:

• Previous unusual response to PC or any of their components (murine proteins and heparin)

• PC administration or inclusion in other randomized protocols in the previous 30 days

• Do not resuscitate orders

• Refractory cardiogenic shock

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Sepsis

Intervention

Drug:
• Protein C concentrate

Locations

Country	Name	City	State
Italy	Ospedale San Raffaele di Milano, Italy	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Università Vita-Salute San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite endpoint of number of participant with mortality and/or prolonged ICU stay