A Clinical Study of Lyophilized Plasma in Patients on Warfarin

Anticoagulant Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01541098
• Other study ID #: 2011-I-LyP-1
• Status: Withdrawn
• Phase: Phase 2
• First received: February 16, 2012
• Last updated: March 17, 2015
• Start date: January 2015
• Est. completion date: January 2016

Study information

• Verified date: March 2015
• Source: HemCon Medical Technologies, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anticoagulant Therapy

Intervention

Biological:
• Lyophilized Plasma
Licensed plasma that has been lyophilized.
• Licensed Plasma
Plasma that has been authorized for transfusion.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
HemCon Medical Technologies, Inc

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes