? DESCRIPTION (provided by applicant): 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. Despite the paucity of evidence to guide plasma transfusions, many clinicians believe they are lowering the risk of major bleeding by using plasma. Furthermore, consensus guidelines for periprocedural management of coagulation recommend that the INR be corrected to less than 1.5. This recommendation was derived by expert opinion and not high quality evidence from randomized clinical trials. Yet, plasma transfusion also has serious side effects including transfusion associated cardiac overload (TACO or congestive heart failure) that results from the volume of plasma administered, and from the much less common transfusion related acute lung injury (TRALI). Given the potential for harm and the lack of data supporting the efficacy of plasma prior to nonsurgical invasive procedures, it is essential to conduct a definitiv trial that informs clinicians' decisions whether to use plasma. We propose a pilot trial that will provide the necessary and sufficient experience needed to plan and successfully complete a large multicenter trial that provides the essential evidence to guide the transfusion of plasma. The aims of this proposed trial are 1) to evaluate the feasibility of a research protocol that will lead to a large-scale clinical trial designed to evaluate the effectiveness of plasma in patients with prolonged INR undergoing an invasive procedure. 2) To compare the risk of major bleeding and complications in patients with INR of 1.5 to 1.99 undergoing an invasive procedure who are randomly allocated to receive plasma versus no treatment. Relevance This pilot trial will provide the critical experience to establish the feasibility and optimal study design for a definitive tria that is urgently needed to guide the use of fresh frozen plasma.
|Effective start/end date||9/1/15 → 8/31/19|
- National Institutes of Health: $360,747.00
- National Institutes of Health: $379,788.00