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Completed

NCT Number: NCT00302965

Effectiveness of Plasma Transfusions in Critical Care Patients

Measuring the effectiveness of plasma transfusions in critical care

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Key information

Conditions

Coagulation Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

About this study

Measuring the effectiveness of plasma transfusions in critical care

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Frozen Plasma

Drug

Primary outcomes

  1. the proportion of patients with a correction of the INR (Determined by the treating physician)

  2. Secondary outcomes include changes in coagulation tests (INR, aPTT and individual coagulation factor levels

  3. bleeding and complications from FFP (fluid overload, transfusion reactions).

Secondary outcomes

  1. Secondary outcomes include changes in coagulation tests (INR, aPTT and individual coagulation factor levels

  2. bleeding and complications from FFP (fluid overload, transfusion reactions).

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Mar 15, 2006
Registry last updated
Oct 21, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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