Clinical Study of Lyophilized Plasma in Patients With Liver Disease

Phase 2

Withdrawn

• Conditions: Liver Disease
• Interventions: Biological: Lyophilized Plasma; Biological: Licensed Plasma

• Registration Number: NCT01547078
• Lead Sponsor: HemCon Medical Technologies, Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-10
• Study First Submitted QC: 2012-03-02
• Study First Posted: 2012-03-07
• Study Start: 2015-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-03-18
• Primary Completion: 2016-01
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lyophilized Plasma	Lyophilized Plasma	-
Licensed Plasma	Licensed Plasma	-

Primary Outcome Measures

Name	Time	Method
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.