Effectiveness of Plasma Transfusions in Critical Care Patients

October 17, 2008 updated by: Ottawa Hospital Research Institute

Effectiveness of Fresh Frozen Plasma in Critical Care (EPICC) Trial

Measuring the effectiveness of plasma transfusions in critical care

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Measuring the effectiveness of plasma transfusions in critical care

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ICU Admission
  • INR > 1.2
  • Require FFP for active bleeding and/or prior to an invasive procedure
  • Are able to provide consent or proxy consent

Exclusion Criteria:

  • Congenital or acquired coagulation factor deficiency
  • Platelet count < 50 x 109 /L and have NOT received subsequent platelet transfusion
  • Consumptive coagulopathy (bleeding ≥ 3 sites and ↓ plts, ↓ fib, ↑ d dimer)
  • Uncontrolled bleeding (6 or more units of blood in the last 6 hours)
  • Receiving therapeutic doses of heparin/heparinoid (must be off for at least 6 hours)
  • Have received clotting factor concentrates in the previous 24 hours
  • Are expected to require surgery in the next 48 hours
  • Survival expected to be less than 48 hours
  • Currently enrolled in another study with a similar outcome
  • Previous enrollment in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
the proportion of patients with a correction of the INR (Determined by the treating physician)
Secondary outcomes include changes in coagulation tests (INR, aPTT and individual coagulation factor levels
bleeding and complications from FFP (fluid overload, transfusion reactions).

Secondary Outcome Measures

Outcome Measure
Secondary outcomes include changes in coagulation tests (INR, aPTT and individual coagulation factor levels
bleeding and complications from FFP (fluid overload, transfusion reactions).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Investigators

  • Principal Investigator: Alan Tinmouth, MD, OHRI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

March 13, 2006

First Posted (Estimate)

March 15, 2006

Study Record Updates

Last Update Posted (Estimate)

October 21, 2008

Last Update Submitted That Met QC Criteria

October 17, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2004341-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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