NCT00302965

Brief Summary

Measuring the effectiveness of plasma transfusions in critical care

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 15, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

October 21, 2008

Status Verified

October 1, 2008

Enrollment Period

1.7 years

First QC Date

September 13, 2005

Last Update Submit

October 17, 2008

Conditions

Coagulation

Keywords

PlasmaTraumaCritical Care

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

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

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

Interventions

Frozen PlasmaDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

MeSH Terms

Conditions

ThrombosisWounds and Injuries

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Alan Tinmouth, MD

    OHRI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

March 15, 2006

Study Start

April 1, 2005

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

October 21, 2008

Record last verified: 2008-10

Locations

CA(1)