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A Clinical Study of Lyophilized Plasma in Patients on Warfarin

This study is not yet open for participant recruitment.
Verified April 2013 by HemCon Medical Technologies, Inc
Sponsor:
Information provided by (Responsible Party):
HemCon Medical Technologies, Inc
ClinicalTrials.gov Identifier:
NCT01541098
First received: February 16, 2012
Last updated: April 9, 2013
Last verified: April 2013
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: A Phase II Clinical Study of Lyophilized Plasma in Patients on Warfarin

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

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) ] [ Designated as safety issue: Yes ]
    The primary safety objective is to assess the adverse events after infusion of lyophilized plasma compared to control.


Estimated Enrollment: 100
Study Start Date: September 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01541098

Contacts
Contact: Jody Oyama jody.oyama@hemcon.com

Sponsors and Collaborators
HemCon Medical Technologies, Inc
  More Information

No publications provided

Responsible Party: HemCon Medical Technologies, Inc
ClinicalTrials.gov Identifier: NCT01541098     History of Changes
Other Study ID Numbers: 2011-I-LyP-1
Study First Received: February 16, 2012
Last Updated: April 9, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013