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CompletedNCT00302965Updated Oct 21, 2008

Effectiveness of Plasma Transfusions in Critical Care Patients

A Phase 1/2 interventional study of Frozen Plasma in Coagulation, sponsored by Ottawa Hospital Research Institute. Completed at 1 site in Canada. Per ClinicalTrials.gov, last updated 2008-10-21.

Sponsored by Ottawa Hospital Research Institute · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
70
Allocation
Randomized
Sex
All
01

Study summary

Measuring the effectiveness of plasma transfusions in critical care

Read the detailed description

Measuring the effectiveness of plasma transfusions in critical care

02

Conditions studied

  • Coagulation

Keywords

  • Plasma
  • Trauma
  • Critical Care
03

In context

Lead sponsor

Ottawa Hospital Research Institute is the lead sponsor of 538 studies on the registry; 100 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double
Enrollment
70 participants (estimated)

Interventions

  • DrugFrozen Plasma
06

What researchers measure

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).

07

Study locations

1 site
  • Ottawa Hospital
    Ottawa, Ontario K1H 8L6, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00302965
Lead sponsor
Ottawa Hospital Research Institute
First posted
Mar 15, 2006
Start date
Apr 2005
Primary completion
Dec 2006
Completion
Dec 2006
Last update
Oct 21, 2008

Study contacts

Alan Tinmouth, MD
principal investigator · OHRI
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.

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