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A Clinical Study of Lyophilized Plasma in Patients on Warfarin

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ClinicalTrials.gov Identifier: NCT01541098
Recruitment Status : Withdrawn
First Posted : February 29, 2012
Last Update Posted : March 18, 2015
Information provided by (Responsible Party):
HemCon Medical Technologies, Inc

Brief Summary:
This is a multi center, phase 2 randomized controlled study to determine the effect of lyophilized plasma in patients on warfarin therapy.

Condition or disease Intervention/treatment Phase
Anticoagulant Therapy 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 II Clinical Study of Lyophilized Plasma in Patients on Warfarin
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: Blood Thinners
U.S. FDA Resources

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 72 hours) ]
    The primary safety objective is to assess the adverse events after infusion of lyophilized plasma compared to control.

Information from the National Library of Medicine

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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.

Responsible Party: HemCon Medical Technologies, Inc
ClinicalTrials.gov Identifier: NCT01541098     History of Changes
Other Study ID Numbers: 2011-I-LyP-1
First Posted: February 29, 2012    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015

Additional relevant MeSH terms: