Plasma exchange as therapy for disseminated intrevascular coagulation (DIC)- a randomized-controlled trial - PEx in DIC

Phase 1

• Conditions: Disseminated intravascular coagulation

• Registration Number: EUCTR2010-024263-40-AT
• Lead Sponsor: Medizinische Universität Wien, Univ. Klinik f. Klinische Pharmakologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-24
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 200

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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