Administration of Protein C Concentrates in Adult Critically Ill Septic Patients

NCT01705808 | Terminated Phase 3

• 1 other identifier: OSR/40/04/12
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• Composite endpoint of number of participant with mortality and/or prolonged ICU stay

Study Arms (2)

Protein C concentrate

EXPERIMENTAL

Drug: Protein C concentrate

Placebo

PLACEBO COMPARATOR

Drug: Protein C concentrate

Interventions

Protein C concentrate DRUG

Placebo; Protein C concentrate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous unusual response to PC or any of their components (murine proteins and heparin)
• Do not resuscitate orders
• Refractory cardiogenic shock

Sponsors & Collaborators

• Università Vita-Salute San Raffaele: lead

Study Sites (1)

Ospedale San Raffaele di Milano, Italy

Milan, Milano, 20132, Italy

Location

MeSH Terms

Conditions

Sepsis

Interventions

Protein C

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Enzyme Precursors; Enzymes and Coenzymes; Glycoproteins; Glycoconjugates; Carbohydrates; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Blood Coagulation Factor Inhibitors; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research, Department of Anesthesiology and Intensive Care

Study Record Dates

• First Submitted: July 25, 2012
• First Posted: October 12, 2012
• Study Start: September 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: October 1, 2014
• Last Updated: December 15, 2015

Record last verified: 2015-12

Locations

IT (1)