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Administration of Protein C Concentrates in Adult Critically Ill Septic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01705808
Recruitment Status : Terminated
First Posted : October 12, 2012
Last Update Posted : December 15, 2015
Sponsor:
Information provided by (Responsible Party):
Giovanni Landoni, Università Vita-Salute San Raffaele

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.

Condition or disease Intervention/treatment Phase
Sepsis Drug: Protein C concentrate Phase 3

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Administration of Protein C Concentrates in Adult Critically Ill Septic Patients
Study Start Date : September 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
Drug Information available for: Protein C

Arm Intervention/treatment
Experimental: Protein C concentrate Drug: Protein C concentrate
Placebo Comparator: Placebo Drug: Protein C concentrate



Primary Outcome Measures :
  1. Composite endpoint of number of participant with mortality and/or prolonged ICU stay


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01705808


Locations
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Italy
Ospedale San Raffaele di Milano, Italy
Milano, Italy, 20132
Sponsors and Collaborators
Università Vita-Salute San Raffaele

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Responsible Party: Giovanni Landoni, Head of Research, Department of Anesthesiology and Intensive Care, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier: NCT01705808    
Other Study ID Numbers: OSR/40/04/12
First Posted: October 12, 2012    Key Record Dates
Last Update Posted: December 15, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes
Protein C
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action