Liver Disease
Conditions
Brief summary
A multi-center, phase 2, randomized, controlled study of the effect of lyophilized plasma in patients with liver disease.
Interventions
BIOLOGICALLyophilized Plasma
Licensed plasma that has been lyophilized.
BIOLOGICALLicensed Plasma
Plasma that has been authorized for transfusion.
Sponsors
HemCon Medical Technologies, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess and compare adverse events | Duration of Study (Less than or equal to 7 days) | The primary safety objective is to assess the incidence of adverse events of lyophilized plasma compared to control. |
Outcome results
None listed