Does Plasma Reduce Bleeding in Patients Undergoing Invasive Procedures

Rutgers The State University of New Jersey

Status and phase: Completed; Phase 3

Conditions: Hemorrhage; Blood Coagulation Disorders

Treatments: Biological: Fresh frozen plasma transfusion

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02637427

1R34HL125804-01A1 (U.S. NIH Grant/Contract)

Pro20150001801

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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57 participants in 2 patient groups

Fresh frozen plasma transfusion

Experimental group

Description:

Pre-procedure fresh frozen plasma transfusion (15 cc per Kg, range 10-20 cc/Kg, to a maximum of 5 units)

Treatment:

Biological: Fresh frozen plasma transfusion

No transfusion

No Intervention group

Description:

No transfusions prior to the procedure