Clinical Study of Lyophilized Plasma in Patients With Liver Disease
NCT ID: NCT01547078
Last Updated: 2015-03-18
Study Results
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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WITHDRAWN
PHASE2
INTERVENTIONAL
2015-01-31
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Licensed Plasma
Licensed Plasma
Plasma that has been authorized for transfusion.
Lyophilized Plasma
Lyophilized Plasma
Licensed plasma that has been lyophilized.
Interventions
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Lyophilized Plasma
Licensed plasma that has been lyophilized.
Licensed Plasma
Plasma that has been authorized for transfusion.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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HemCon Medical Technologies, Inc
INDUSTRY
Responsible Party
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Other Identifiers
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2011-I-LyP-2
Identifier Type: -
Identifier Source: org_study_id
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