A Clinical Study of Lyophilized Plasma in Patients on Warfarin

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 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: February 26, 2014
Last verified: February 2014
  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:


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: 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.

  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
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.

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: February 26, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 22, 2014