Does Plasma Reduce Bleeding in Patients Undergoing Invasive Procedures
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 57
- Locations
- 2
- Primary Endpoint
- Change in Hemoglobin Level
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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)
Intervention: Fresh frozen plasma transfusion (Biological)
No transfusion
No transfusions prior to the procedure
Outcomes
Primary Outcomes
Change in Hemoglobin Level
Time Frame: within 2 days post procedure
Change from pre-procedure hemoglobin to lowest within 2 days after procedure
Secondary Outcomes
- Number of Participants With Major Bleed(with 2 days post procedure)
- Number of Participants With Infection(within 2 days post procedure)
- Number of Red Blood Cell Transfusions(within 2 days post procedure)
- Number of Participants With Transfusion Associated Cardiac Overload (TACO)(within 2 days post procedure)
- Number of Participants With Transfusion Related Acute Lung Injury (TRALI).(with 2 days post procedure)
- Change in International Normalized Ratio (INR) Level Post Procedure(day of procedure)
- Change in INR Level Day 1(day 1 post procedure)
- Change in INR Level Day 2(day 2 post procedure)
- Mortality (Number of Participants)(in-hospital up to 7 days)
- Number of Participants With ICU Admission(within 2 days post procedure)
Investigators
Jeffrey L Carson, MD
Principal Investigator
Rutgers, The State University of New Jersey