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Effectiveness of Plasma Transfusions in Critical Care Patients

This study has been completed.
Sponsor:
Information provided by:
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00302965
First received: September 13, 2005
Last updated: October 17, 2008
Last verified: October 2008
History of Changes
  Purpose

Measuring the effectiveness of plasma transfusions in critical care


Condition Intervention Phase
Coagulation
 Drug: Frozen Plasma
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effectiveness of Fresh Frozen Plasma in Critical Care (EPICC) Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ottawa Hospital 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:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00302965

Locations
Canada, Ontario
Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Alan Tinmouth, MD OHRI
  More Information

No publications provided

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

Keywords provided by Ottawa Hospital Research Institute:
Plasma
Trauma
Critical Care

ClinicalTrials.gov processed this record on May 23, 2013