Clinical Study of Lyophilized Plasma in Patients With Liver Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01547078
Recruitment Status : Withdrawn
First Posted : March 7, 2012
Last Update Posted : March 18, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Liver Disease Biological: Lyophilized Plasma Biological: Licensed Plasma Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: A Phase 2 Clinical Study of Lyophilized Plasma in Patients With Acquired Coagulopathy Due to Liver Disease
Study Start Date : January 2015
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases

Arm Intervention/treatment
Active Comparator: Licensed Plasma Biological: Licensed Plasma
Plasma that has been authorized for transfusion.

Experimental: Lyophilized Plasma Biological: Lyophilized Plasma
Licensed plasma that has been lyophilized.

Primary Outcome Measures :
  1. Assess and compare adverse events [ Time Frame: 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Responsible Party: HemCon Medical Technologies, Inc Identifier: NCT01547078     History of Changes
Other Study ID Numbers: 2011-I-LyP-2
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases