Effectiveness of Plasma Transfusions in Critical Care Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2006-12-31

Brief Summary

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Measuring the effectiveness of plasma transfusions in critical care

Detailed Description

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Measuring the effectiveness of plasma transfusions in critical care

Conditions

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Coagulation

Keywords

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Plasma Trauma Critical Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Frozen Plasma

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Alan Tinmouth, MD

Role: PRINCIPAL_INVESTIGATOR

OHRI

Locations

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Ottawa Hospital

Ottawa, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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2004341-01

Identifier Type: -

Identifier Source: org_study_id