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administration of protein C in patients with severe sepsis.

Administration of concentrated Protein C in patients with severe sepsis and contraindications to activated protein C. A monocentric, randomised placebo-controlled study.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-004834-32-IT
Enrollment
Unknown
Registered
2012-03-08
Start date
2012-06-08
Completion date
Unknown
Last updated
2012-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients affected by severe sepsis admitted to intensive care MedDRA version: 14.1 Level: PT Classification code 10040047 Term: Sepsis System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: CEPROTIN Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: proteina C CAS Number: NA Current Sponsor code: NA Other descriptive name: NA Concentration

Sponsors

FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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—

Countries

Italy

Contacts

Public ContactAnest. e Rianim. Cardiotoracovasc.

Fondazione San Raffaele del Monte Tabor

federico.pappalardo@hsr.it022643.7154

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026