Effectiveness of Plasma Transfusions in Critical Care Patients - Full Text View

Sponsored by:	Ottawa Health Research Institute
Information provided by:	Ottawa Health Research Institute
ClinicalTrials.gov Identifier:	NCT00302965

Purpose

Measuring the effectiveness of plasma transfusions in critical care

Condition	Intervention	Phase
Coagulation	Drug: Frozen Plasma	Phase I Phase II

MedlinePlus related topics: Blood Transfusion and Donation Critical Care

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Effectiveness of Fresh Frozen Plasma in Critical Care (EPICC) Trial

Further study details as provided by Ottawa Health Research Institute:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	70
Study Start Date:	April 2005
Study Completion Date:	December 2006
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Detailed Description:

Measuring the effectiveness of plasma transfusions in critical care

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00302965

Locations

Sponsors and Collaborators

Ottawa Health Research Institute

Investigators

Principal Investigator:

Alan Tinmouth, MD

OHRI

More Information

Study ID Numbers:	2004341-01
Study First Received:	September 13, 2005
Last Updated:	October 17, 2008
ClinicalTrials.gov Identifier:	NCT00302965
Health Authority:	Canada: Health Canada

Keywords provided by Ottawa Health Research Institute:

Plasma
Trauma
Critical Care

Study placed in the following topic categories:

Wounds and Injuries

ClinicalTrials.gov processed this record on January 16, 2009