Anticoagulant Therapy
Conditions
Brief summary
This is a multi center, phase 2 randomized controlled study to determine the effect of lyophilized plasma in patients on warfarin therapy.
Interventions
BIOLOGICALLyophilized Plasma
Licensed plasma that has been lyophilized.
BIOLOGICALLicensed Plasma
Plasma that has been authorized for transfusion.
Sponsors
HemCon Medical Technologies, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed