Does Plasma Reduce Bleeding in Patients Undergoing Invasive Procedures

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-26

Study Completion Date

2020-11-30

Brief Summary

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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.

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Detailed Description

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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

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Blood Coagulation Disorders Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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)

Group Type EXPERIMENTAL

Fresh frozen plasma transfusion

Intervention Type BIOLOGICAL

Pre-procedure fresh frozen plasma transfusion (15 cc per Kg to a maximum of 5 units)

No transfusion

No transfusions prior to the procedure

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fresh frozen plasma transfusion

Pre-procedure fresh frozen plasma transfusion (15 cc per Kg to a maximum of 5 units)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No