NCT02637427.

Trial name or title	Does Plasma Reduce Bleeding in Patients Undergoing Invasive Procedures?
Methods	Multi‐centre, single‐blind, parallel assignment randomised controlled trial
Participants	Inclusion Criteria: Adults (aged 21 years or older) with an INR between 1.5 and 2.5 undergoing an invasive procedure at the bedside, in an endoscopy suite or in a radiology department 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 catheterisation 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 x 109/L Congenital coagulation disorders Acquired coagulation disorders (i.e., lupus anticoagulant) for which plasma will not correct the disorder Women who are pregnant Unwillingness to consider blood transfusion
Interventions	Transfusion of fresh frozen plasma (10 mL to 20mL/kg to a maximum of 5 units) versus no transfusion prior to an invasive procedure
Outcomes	Primary outcomes: change in haemoglobin level; trial feasibility Secondary outcomes: rate of red cell transfusion; transfusion‐associated circulatory overload; transfusion‐associated acute lung injury; major bleeding; change in INR post‐procedure, at day one and day two; mortality; infection; ICU admission
Starting date	January 2016 Estimated Study Completion Date: May 2017
Contact information	Dr Paul Ness ‐ pness@jhmi.edu
Notes	Trial registration: NCT02637427 on 16 December 2015 Planned recruitment: 110 adults Sponsor: National Heart, Lung, and Blood Institute (NHLBI) Location of trial: United States Number of study centres: 4

APTT: activated partial thromboplastin time; ICU: intensive care unit; INR: International Normalised Ratio