Clinical Study of Lyophilized Plasma in Patients With Liver Disease

HemCon Medical Technologies

Status and phase: Withdrawn; Phase 2

Conditions: Liver Disease

Treatments: Biological: Licensed Plasma; Biological: Lyophilized Plasma

Study type: Interventional

Funder types: Industry

Identifiers

NCT01547078

2011-I-LyP-2

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female patients at least 18 years of age.
2. Patients with liver disease.
3. Patients who have need for plasma therapy for a surgical or an invasive procedure or who have evidence of bleeding.
4. Patients with an elevated international normalized ratio due to liver disease.
5. 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.
6. Patients able and willing to comply with the procedures laid out in the study protocol.

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

0 participants in 2 patient groups

Licensed Plasma

Active Comparator group

Treatment:

Biological: Licensed Plasma

Lyophilized Plasma

Experimental group

Treatment:

Biological: Lyophilized Plasma