A Clinical Study of Lyophilized Plasma in Patients on Warfarin

Phase 2

Withdrawn

• Conditions: Anticoagulant Therapy
• Interventions: Biological: Licensed Plasma; Biological: Lyophilized Plasma

• Registration Number: NCT01541098
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-16
• Study First Submitted QC: 2012-02-28
• Study First Posted: 2012-02-29
• Study Start: 2015-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-03-18
• Primary Completion: 2016-01
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Licensed Plasma	Licensed Plasma	-
Lyophilized Plasma	Lyophilized Plasma	-

Primary Outcome Measures

Name	Time	Method
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.