NCT01187030

Brief Summary

There is little evidence to guide the current use of Frozen Plasma. Despite this, over 260,000 units of frozen plasma are transfused in Canada annually. Based on the limited published data available, the pattern of practice for Frozen Plasma transfusions is highly variable and an important number of Frozen Plasma transfusions appear to be inappropriate. Given inappropriate use, it is inevitable that a percentage of patients experience unnecessary and potentially life-threatening adverse transfusion reactions. Current guidelines for Frozen Plasma offer little help in guiding specific clinical decisions as their recommendations lack sufficient clinical details. This lack of detail also hinders the utility of these guidelines to help monitor and improve clinical practice. Further research examining Frozen Plasma transfusions including an understanding our current use is critical to improve the utilization of this valuable and limited resource.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,580

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2008

Typical duration for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 23, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

May 23, 2012

Status Verified

May 1, 2012

Enrollment Period

2.8 years

First QC Date

August 20, 2010

Last Update Submit

May 22, 2012

Conditions

Blood Component Transfusion

Keywords

Frozen PlasmaFresh Frozen PlasmaProthrombin Complex ConcentratesRAND UCLAModified Delphi MethodologyExpert PanelAppropriateness Rating

Outcome Measures

Primary Outcomes (1)

  • The primary outcome for the appropriateness of Frozen Plasma transfusions will be the proportion of appropriate transfusion episodes.

    Each transfusion episode will be the unit of analysis as a single patient may receive both inappropriate and appropriate transfusions.

    2 months

Secondary Outcomes (1)

  • The number of units transfused per patient will be the secondary outcome.

    2 months

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients at 10 academic medical centres (17 hospitals) across Canada

You may qualify if:

  • All subjects receiving frozen plasma or PCC transfusions

You may not qualify if:

  • No subjects excluded -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Alan T Tinmouth, MD, MSc

    Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2010

First Posted

August 23, 2010

Study Start

May 1, 2008

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

May 23, 2012

Record last verified: 2012-05