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

Medizinische Universität Wien, Univ. Klinik f. Klinische Pharmakologie0 个研究点目标入组 200 人开始时间: 2011年8月24日最近更新: 2019年4月30日

适应症

试验速览

暂无简介。

•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.
•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

•Any of the following will exclude a subject from the trial:
•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

发起方

Medizinische Universität Wien, Univ. Klinik f. Klinische Pharmakologie