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Administration of Protein C Concentrates in Adult Critically Ill Septic Patients

NCT ID: NCT01705808

Last Updated: 2015-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Protein C concentrate

Group Type EXPERIMENTAL

Protein C concentrate

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Protein C concentrate

Intervention Type DRUG

Interventions

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Protein C concentrate

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università Vita-Salute San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Giovanni Landoni

Head of Research, Department of Anesthesiology and Intensive Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ospedale San Raffaele di Milano, Italy

Milan, Milano, Italy

Site Status

Countries

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Italy

Other Identifiers

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OSR/40/04/12

Identifier Type: -

Identifier Source: org_study_id