A Clinical Study of Lyophilized Plasma in Patients on Warfarin

A Phase II Clinical Study of Lyophilized Plasma in Patients on Warfarin

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

Study Overview

• Status: Withdrawn
• Conditions: Anticoagulant Therapy
• Intervention / Treatment: Biological: Licensed Plasma; Biological: Lyophilized Plasma

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess and Compare Adverse Events	The primary safety objective is to assess the adverse events after infusion of lyophilized plasma compared to control.	Duration of Study (Less than or equal to 72 hours)

Collaborators and Investigators

• Sponsor: HemCon Medical Technologies, Inc

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): January 1, 2016
• Study Completion (Anticipated): January 1, 2016

Study Registration Dates

• First Submitted: February 16, 2012
• First Submitted That Met QC Criteria: February 28, 2012
• First Posted (Estimate): February 29, 2012

Study Record Updates

• Last Update Posted (Estimate): March 18, 2015
• Last Update Submitted That Met QC Criteria: March 17, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 2011-I-LyP-1