Clinical trial NCT02637427: Does Plasma Reduce Bleeding in Patients Undergoing Invasive Procedures
Official title: Does Plasma Reduce Bleeding in Patients Undergoing Invasive Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Blood Coagulation Disorders
Hemorrhage
Keywords: Fresh frozen plasma
Bleeding
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
name: Johns Hopkins University
name: University of Washington
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2015-12-22
Enrollment: 57
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. undergoing a surgical procedure in the operating room;
2. active bleeding;
3. undergoing a procedure involving or proximal to the central nervous system or spinal cord;
4. cardiac catheterization,
5. using 4 factor plasma concentrates
6. using systemic heparin/heparinoid therapy, direct factor X inhibitors and other anticoagulants for which plasma will not correct prolonged INR;
7. platelet count less than 50,000/ul,
8. congenital coagulation disorders;
9. acquired disorders (i.e., lupus anticoagulant) for which plasma will not correct the disorder;
10. women who are pregnant and;
11. unwillingness to consider blood transfusion.

Primary outcomes:
measure: Change in Hemoglobin Level
timeFrame: within 2 days post procedure
Secondary outcomes:
measure: Number of Red Blood Cell Transfusions
timeFrame: within 2 days post procedure
measure: Number of Participants With Transfusion Associated Cardiac Overload (TACO)
timeFrame: within 2 days post procedure
measure: Number of Participants With Transfusion Related Acute Lung Injury (TRALI).
timeFrame: with 2 days post procedure
measure: Number of Participants With Major Bleed
timeFrame: with 2 days post procedure
measure: Change in International Normalized Ratio (INR) Level Post Procedure
timeFrame: day of procedure
measure: Change in INR Level Day 1
timeFrame: day 1 post procedure
measure: Change in INR Level Day 2
timeFrame: day 2 post procedure
measure: Mortality (Number of Participants)
timeFrame: in-hospital up to 7 days
measure: Number of Participants With Infection
timeFrame: within 2 days post procedure
measure: Number of Participants With ICU Admission
timeFrame: within 2 days post procedure
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University, The Johns Hopkins Hospital
state: Maryland
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
Study officials:
affiliation: Rutgers Robert Wood Johnson Medical School
name: Jeffrey L Carson, MD
role: STUDY_CHAIR
References: