Effectiveness of Plasma Transfusions in Critical Care Patients

Ottawa Hospital Research Institute

Status and phase: Completed; Phase 2; Phase 1

Conditions: Coagulation

Treatments: Drug: Frozen Plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT00302965

2004341-01

Details and patient eligibility

About

Measuring the effectiveness of plasma transfusions in critical care

Full description

Measuring the effectiveness of plasma transfusions in critical care

Enrollment: 70 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind