Does Plasma Reduce Bleeding in Patients Undergoing Invasive Procedures

Phase 3

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Fresh frozen plasma transfusion	Fresh frozen plasma transfusion	Pre-procedure fresh frozen plasma transfusion (15 cc per Kg, range 10-20 cc/Kg, to a maximum of 5 units)

Primary Outcome Measures

Name	Time	Method
Change in Hemoglobin Level	within 2 days post procedure	Change from pre-procedure hemoglobin to lowest within 2 days after procedure

Secondary Outcome Measures

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

Locations (2): Johns Hopkins University, The Johns Hopkins Hospital
🇺🇸
Baltimore, Maryland, United States
Robert Wood Johnson University Hospital
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New Brunswick, New Jersey, United States