NCT02637427

Does Plasma Reduce Bleeding in Patients Undergoing Invasive Procedures

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Blood Coagulation Disorders
• Hemorrhage

Interventions

Type	Name	Description
BIOLOGICAL	Fresh frozen plasma transfusion	Pre-procedure fresh frozen plasma transfusion (15 cc per Kg to a maximum of 5 units)

Timeline

• Start date: 2016-02-26
• Primary completion: 2019-06-28
• Completion: 2020-11-01
• First posted: 2015-12-22
• Last updated: 2021-08-18
• Results posted: 2021-08-17

Locations

2 sites across 1 country: United States