This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Clinical Study of Lyophilized Plasma in Patients With Liver Disease

This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
HemCon Medical Technologies, Inc Identifier:
First received: February 10, 2012
Last updated: March 17, 2015
Last verified: March 2015
A multi-center, phase 2, randomized, controlled study of the effect of lyophilized plasma in patients with liver disease.

Condition Intervention Phase
Liver Disease Biological: Lyophilized Plasma Biological: Licensed Plasma Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by HemCon Medical Technologies, Inc:

Primary Outcome Measures:
  • 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.

Enrollment: 0
Study Start Date: January 2015
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: HemCon Medical Technologies, Inc Identifier: NCT01547078     History of Changes
Other Study ID Numbers: 2011-I-LyP-2
Study First Received: February 10, 2012
Last Updated: March 17, 2015

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases processed this record on September 21, 2017