Effectiveness of Plasma Transfusions in Critical Care Patients

Coagulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00302965
• Other study ID #: 2004341-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 13, 2005
• Last updated: October 17, 2008
• Start date: April 2005
• Est. completion date: December 2006

Study information

• Verified date: October 2008
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

Measuring the effectiveness of plasma transfusions in critical care

Description:

Measuring the effectiveness of plasma transfusions in critical care

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coagulation

Intervention

Drug:
• Frozen Plasma

Locations

Country	Name	City	State
Canada	Ottawa Hospital	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

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