A Clinical Study of Lyophilized Plasma in Patients on Warfarin

HemCon Medical Technologies

Status and phase: Withdrawn; Phase 2

Conditions: Anticoagulant Therapy

Treatments: Biological: Licensed Plasma; Biological: Lyophilized Plasma

Study type: Interventional

Funder types: Industry

Identifiers

NCT01541098

2011-I-LyP-1

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Licensed Plasma

Active Comparator group

Treatment:

Biological: Licensed Plasma

Lyophilized Plasma

Experimental group

Treatment:

Biological: Lyophilized Plasma