A Phase 2 Clinical Study of Lyophilized Plasma in Patients With Acquired Coagulopathy Due to Liver Disease

HemCon Medical Technologies, Inc0 sitesJanuary 2015

Overview

A multi-center, phase 2, randomized, controlled study of the effect of lyophilized plasma in patients with liver disease.

Registry

clinicaltrials.gov

Start Date

January 2015

End Date

January 2016

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

HemCon Medical Technologies, Inc

Responsible Party

Sponsor

•Male or female patients at least 18 years of age.
•Patients with liver disease.
•Patients who have need for plasma therapy for a surgical or an invasive procedure or who have evidence of bleeding.
•Patients with an elevated international normalized ratio due to liver disease.
•Patients who have given written informed consent or for whom written informed consent has been obtained from the patient's legal representative on their behalf.
•Patients able and willing to comply with the procedures laid out in the study protocol.

•Patients who are clinically unstable.
•Patients who have received mediations that could interfere with results of laboratory testing.
•Patients who have congenital or acquired coagulopathies of non-hepatic origin.
•Pregnant or nursing women.
•Active illicit drug use.
•Patients participating in another clinical treatment study currently or during the past 1 month prior to study inclusion.
•Patients previously enrolled in this study.