Plasma Utilization Following Cardiac Surgery

NCT01187394 | Completed

• 1 other identifier: 2009769 01
• Study Type: observational
• Target: 970
• Locations: 1 country
• Sites: 1

Brief Summary

In Canada, 218,000 units of fresh frozen plasma and frozen plasma were transfused in 2005.Cardiac surgery patients are the largest recipient group for FP transfusions. Despite this, no studies have characterized the use of FP in relation to coagulation test abnormalities or bleeding, or how these and other clinical determinants influence the decision to transfuse FP. Furthermore, no studies have evaluated the effectiveness of FP transfusions in correcting laboratory abnormalities or treating bleeding in cardiac surgery. Given the varied use of FP transfusions in cardiac surgery, further studies are essential.In order to improve current utilization of FP, current use must be understood, and the relationship between FP transfusions and the clinical factors that affect the decision to transfuse FP.

Conditions

Blood Component Transfusion; Cardiac Surgical Procedures

Keywords

Frozen Plasma; Fresh Frozen Plasma; Cardiac Surgery; Bleeding; Knowledge Translation

Outcome Measures

Primary Outcomes (1)

• Incidence of Frozen Plasma Transfusion

  For FP Transfusions, we will determine the proportion of patients transfused FP for (a) all cardiac surgery patients, (b) for patients with an INR\> 1.2, (c) for patients with an INR \> 1.5 and (d) for patients with no recent coagulation tests available. We will also determine the number of units and volume (mL/kg) for each transfusion order and the total number of units and volume (mL/kg) transfused in addition to the timing of all units transfused in the first 72 hours after cardiac surgery.

  1 month

Secondary Outcomes (1)

• Clinical determinants influencing the decision to transfuse

  1 month

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients at six 6 Canadian Centres

You may qualify if:

• \*All subjects undergoing Cardiopulmonary Bypass surgery
• More detailed Data Collection for subjects:
• who either receive at least one Frozen Plasma Transfusion or
• who have an INR \> 1.2 in the 72 hours following surgery and
• are admitted to an intensive care unit.

You may not qualify if:

• No subjects undergoing cardiopulmonary bypass surgery will be excluded

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Blood Services: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

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 24, 2010
• Study Start: February 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: May 1, 2012
• Last Updated: May 23, 2012

Record last verified: 2012-05

Locations

CA (1)