Does Plasma Reduce Bleeding in Patients Undergoing Invasive Procedures

Completed · Phase 3

Conditions studied: Blood Coagulation Disorders, Hemorrhage

In brief

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.

Key facts

Study ID

NCT02637427

Run by

Rutgers, The State University of New Jersey

People needed

57

Starts

2016-02-26

Expected to finish

2020-11-01

Last updated by the study team

2021-08-18

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• INR level between 1.50 and 2.50 inclusive
• undergoing an invasive procedure at the bedside, endoscopy laboratory, or in radiology

You may not qualify if…

• 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.

Where it is running

• Johns Hopkins University, The Johns Hopkins Hospital — Baltimore, Maryland, United States
• Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States

Full record on ClinicalTrials.gov

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