PEDIATRIC INTENSIVE CARE C PROTEIN HEMOSTASIS STUDY

INTERVENTION: Trade Name: CEPROTIN Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Protein C Concentration unit: IU/kg international unit(s)/kilogram Concentration type: equal Concentration number: 200‐ CONDITION: SEVERE SEPSIS/ SEPTIC SHOCK PRIMARY OUTCOME: Main Objective: TO EVALUATE THE ANTINFLAMMATORY AND ANTITHROMBOTIC EFFECT OF PROTEIN C Primary end point(s): TO EVALUATE THE ANTINFLAMMATORY AND ANTITHROMBOTIC EFFECT OF PROTEIN C Secondary Objective: TO EVALUATE MORBILITY AND ORGAN FAILURE INCLUSION CRITERIA: SEVERE SEPSIS/ SEPTIC SHOCK; AGE: 6 MONTHS ‐ 16 YEARS Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18‐64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range