Clinical Study of Lyophilized Plasma in Patients With Liver Disease

NCT ID: NCT01547078

Last Updated: 2015-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-01-31

Brief Summary

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

Detailed Description

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Conditions

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Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Licensed Plasma

Group Type ACTIVE_COMPARATOR

Licensed Plasma

Intervention Type BIOLOGICAL

Plasma that has been authorized for transfusion.

Lyophilized Plasma

Group Type EXPERIMENTAL

Lyophilized Plasma

Intervention Type BIOLOGICAL

Licensed plasma that has been lyophilized.

Interventions

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Lyophilized Plasma

Licensed plasma that has been lyophilized.

Intervention Type BIOLOGICAL

Licensed Plasma

Plasma that has been authorized for transfusion.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HemCon Medical Technologies, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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2011-I-LyP-2

Identifier Type: -

Identifier Source: org_study_id

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