Does Plasma Reduce Bleeding in Patients Undergoing Invasive Procedures

Study Overview
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Brief Summary
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The purpose of this study is to evaluate prophylactic fresh frozen plasma transfusion in patients with moderately elevated international normalized ratios (INR) prior to undergoing an invasive procedure.

Detailed Description
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Fresh frozen plasma is used very frequently in the US. Many plasma transfusions are given prior to a procedure in order to correct perceived bleeding risk, yet there is little evidence to support that use of plasma reduces bleeding. There has never been an adequately powered trial to establish the efficacy of plasma and document the risks. This pilot study will evaluate the feasibility of conducting a research protocol that will lead to a large scale clinical trial designed to evaluate the treatment effectiveness of prophylactic plasma transfusion in patients with moderately elevated INRs prior to undergoing an invasive procedure outside of the operating room. Study subjects will be randomly allocated to either receive either plasma transfusion prior to the procedure, or to no treatment. Study outcomes will be compared between the two study arms. Recruitment rates, protocol adherence, and rates of study outcomes will be assessed to determine the feasibility of the large scale trial.

Official Title
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Does Plasma Reduce Bleeding in Patients Undergoing Invasive Procedures

Conditions
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Blood Coagulation Disorders, Hemorrhage

Intervention / Treatment
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* Biological: Fresh frozen plasma transfusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: INR level between 1.50 and 2.50 inclusive undergoing an invasive procedure at the bedside, endoscopy laboratory, or in radiology Exclusion Criteria: undergoing a surgical procedure in the operating room; active bleeding; undergoing a procedure involving or proximal to the central nervous system or spinal cord; cardiac catheterization, using 4 factor plasma concentrates using systemic heparin/heparinoid therapy, direct factor X inhibitors and other anticoagulants for which plasma will not correct prolonged INR; platelet count less than 50,000/ul, congenital coagulation disorders; acquired disorders (i.e., lupus anticoagulant) for which plasma will not correct the disorder; women who are pregnant and; unwillingness to consider blood transfusion.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fresh frozen plasma transfusion<br>Pre-procedure fresh frozen plasma transfusion (15 cc per Kg, range 10-20 cc/Kg, to a maximum of 5 units) | Biological: Fresh frozen plasma transfusion<br>* Pre-procedure fresh frozen plasma transfusion (15 cc per Kg to a maximum of 5 units)<br>|
| No Intervention: No transfusion<br>No transfusions prior to the procedure | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemoglobin Level | Change from pre-procedure hemoglobin to lowest within 2 days after procedure | within 2 days post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Red Blood Cell Transfusions | Differences in number of units of red blood cell transfusions between the two study arms | within 2 days post procedure | 
| Number of Participants With Transfusion Associated Cardiac Overload (TACO) | Difference in rates between the two study arms | within 2 days post procedure | 
| Number of Participants With Transfusion Related Acute Lung Injury (TRALI). | Difference in rates between the two study arms | with 2 days post procedure | 
| Number of Participants With Major Bleed | 2g/dL or greater fall in hemoglobin level | with 2 days post procedure | 
| Change in International Normalized Ratio (INR) Level Post Procedure | Change from pre-procedure INR level | day of procedure | 
| Change in INR Level Day 1 | Change from pre-procedure INR level | day 1 post procedure | 
| Change in INR Level Day 2 | Change from pre-procedure INR level | day 2 post procedure | 
| Mortality (Number of Participants) | Death | in-hospital up to 7 days | 
| Number of Participants With Infection | Pneumonia or blood stream infection | within 2 days post procedure | 
| Number of Participants With ICU Admission | new admission to the intensive care unit | within 2 days post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fresh frozen plasma, Bleeding