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A Clinical Study of Lyophilized Plasma in Patients on Warfarin

This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
HemCon Medical Technologies, Inc Identifier:
First received: February 16, 2012
Last updated: March 17, 2015
Last verified: March 2015
This is a multi center, phase 2 randomized controlled study to determine the effect of lyophilized plasma in patients on warfarin therapy.

Condition Intervention Phase
Anticoagulant Therapy
Biological: Lyophilized Plasma
Biological: Licensed Plasma
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: A Phase II Clinical Study of Lyophilized Plasma in Patients on Warfarin

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 72 hours) ]
    The primary safety objective is to assess the adverse events after infusion 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. Patients receiving oral anticoagulation with warfarin derived agents.
  2. Patients who have need for urgent surgery, an invasive procedure or identification of a patient with active bleeding where oral or parenteral vitamin K therapy is deemed too slow in its action for reversal of warfarin anticoagulant effects.
  3. Patients with an elevated international normalized ratio.

Exclusion Criteria

  1. Patients who are clinically unstable.
  2. Patients who have congenital or acquired coagulopathies (other than warfarin therapy).
  3. Patients who have received medications that could interfere with the results of laboratory testing.
  4. Pregnant or nursing women.
  5. Patients participating in another clinical treatment study currently or during the past 1 month prior to study inclusion.
  6. Patients previously enrolled in this study.
  7. Active illicit drug use.
  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: NCT01541098     History of Changes
Other Study ID Numbers: 2011-I-LyP-1
Study First Received: February 16, 2012
Last Updated: March 17, 2015

Additional relevant MeSH terms:
Anticoagulants processed this record on April 25, 2017