Disseminated intravascular coagulation
Conditions
Interventions
Trade Name: Octaplas S/D
Pharmaceutical Form: Infusion
INN or Proposed INN: pooled human plasma
CAS Number: A745B9501
Current Sponsor co
Sponsors
Medizinische Universität Wien, Univ. Klinik f. Klinische Pharmakologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with sepsis induced DIC are severely compromised, usually intubated in ICU, and unable to consent. Thus a waiver of consent is requested from the Ethics Committee. • Age >18 • Underlying disease known to be associated with DIC • Non-surgical patients: Development of an ISTH DIC score >5 within the last 24h • Surgical patients: surgery ended > 96h, no relevant active bleeding, signs of underlying infection and ISTH DIC score >5 • Burn patients: > 20% total burn surface area of 2° and 3° are eligible any time after admission even before overt DIC develops • Patients accessible to follow-up Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: Any of the following will exclude a subject from the trial: • Pregnancy • Known HIV or HCV infection • Known allergy to plasma or plasma related products or known IgA deficiency and/or history of severe hypersensitivity reaction • Any condition that interferes with the inclusion as to the discretion of the investigator • Treatment with an investigational drug within three weeks prior to this trial or current participation in an other trial • Patients with malignancies or other endstage disease with life expectation of less than three months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore, whether plasma exchange (PEx) added to the best supportive care will reduce 28 day mortality in DIC patients;Secondary Objective: to investigate whether PEx added to the best supportive care will reduce 90 day mortality, is a feasible and safe procedure and to measure coagulation and inflammatory parameters;Primary end point(s): 28 day mortality | — |
Countries
Austria
Outcome results
None listed