A Clinical Study of Lyophilized Plasma in Patients on Warfarin

• Sponsor: HemCon Medical Technologies, Inc (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT01541098
• Collaborator: (none)
• Enrollment: 0
• Arms: 2
• Duration (Months): 12

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Jan 1, 2015
• Anticipated Primary Completion Date: Jan 1, 2016
• Anticipated Study Completion Date: Jan 1, 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Assess and Compare Adverse Events [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Locations

No locations specified.

Sponsors and Collaborators

• HemCon Medical Technologies, Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: HemCon Medical Technologies, Inc
• ClinicalTrials.gov Identifier: NCT01541098
• Other Study ID Numbers: 2011-I-LyP-1
• First Posted: Feb 29, 2012
• Last Update Posted: Mar 18, 2015
• Last Verified: Mar 1, 2015

Study Results

No Results Posted as of Mar 18, 2015