Does Plasma Reduce Bleeding in Patients Undergoing Invasive Procedures

Rutgers, The State University of New Jersey57 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Blood Coagulation Disorders Hemorrhage

Interventions

Fresh frozen plasma transfusionBIOLOGICAL

Pre-procedure fresh frozen plasma transfusion (15 cc per Kg to a maximum of 5 units)

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. INR level between 1.50 and 2.50 inclusive 2. undergoing an invasive procedure at the bedside, endoscopy laboratory, or in radiology Exclusion Criteria: 1. undergoing a surgical procedure in the operating room; 2. active bleeding; 3. undergoing a procedure involving or proximal to the central nervous system or spinal cord; 4. cardiac catheterization, 5. using 4 factor plasma concentrates 6. using systemic heparin/heparinoid therapy, direct factor X inhibitors and other anticoagulants for which plasma will not correct prolonged INR; 7. platelet count less than 50,000/ul, 8. congenital coagulation disorders; 9. acquired disorders (i.e., lupus anticoagulant) for which plasma will not correct the disorder; 10. women who are pregnant and; 11. unwillingness to consider blood transfusion.

Locations (2)

Johns Hopkins University, The Johns Hopkins Hospital

Baltimore, Maryland, United States

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

Outcomes

Primary Outcomes

Change in Hemoglobin Level

Change from pre-procedure hemoglobin to lowest within 2 days after procedure

Time frame: within 2 days post procedure

Secondary Outcomes

Number of Red Blood Cell Transfusions

Differences in number of units of red blood cell transfusions between the two study arms

Time frame: within 2 days post procedure

Number of Participants With Transfusion Associated Cardiac Overload (TACO)

Difference in rates between the two study arms

Time frame: within 2 days post procedure

Number of Participants With Transfusion Related Acute Lung Injury (TRALI).

Difference in rates between the two study arms

Time frame: with 2 days post procedure

Number of Participants With Major Bleed

2g/dL or greater fall in hemoglobin level

Time frame: with 2 days post procedure

Change in International Normalized Ratio (INR) Level Post Procedure

Change from pre-procedure INR level

Time frame: day of procedure

Change in INR Level Day 1

Change from pre-procedure INR level

Time frame: day 1 post procedure

Change in INR Level Day 2

Change from pre-procedure INR level

Time frame: day 2 post procedure

Data from ClinicalTrials.gov

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