NCT01541098

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_2

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 29, 2012

Completed
2.8 years until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 18, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

February 16, 2012

Last Update Submit

March 17, 2015

Conditions

Anticoagulant Therapy

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (2)

Licensed Plasma

ACTIVE COMPARATOR
Biological: Licensed Plasma

Lyophilized Plasma

EXPERIMENTAL
Biological: Lyophilized Plasma

Interventions

Lyophilized PlasmaBIOLOGICAL

Licensed plasma that has been lyophilized.

Lyophilized Plasma
Licensed PlasmaBIOLOGICAL

Plasma that has been authorized for transfusion.

Licensed Plasma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients receiving oral anticoagulation with warfarin derived agents.
  • 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.
  • Patients with an elevated international normalized ratio.

You may not qualify if:

  • Patients who are clinically unstable.
  • Patients who have congenital or acquired coagulopathies (other than warfarin therapy).
  • Patients who have received medications that could interfere with the results of laboratory testing.
  • Pregnant or nursing women.
  • Patients previously enrolled in this study.
  • Active illicit drug use.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2012

First Posted

February 29, 2012

Study Start

January 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

March 18, 2015

Record last verified: 2015-03