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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 25, 2014