Fresh-Frozen Plasma Infusions to Reduce Risk of Bleeding Related to Invasive Procedures

Summary

This study will compare patients with mild to moderate prolongation of the INR test who receive FFP infusions prior to invasive hepatobiliary procedures for bleeding complications to patients who do not receive FFP infusions. Bleeding complications will be defined as meeting one or more of the following:

1. Intrahepatic hematoma greater than 1 ml/kg of patient weight as seen on post-procedure ultrasound examination performed between 4 to 30 hours after the procedure.
2. Greater than 1.6g/dL hemoglobin decline measured within 4 to 30 hours post-procedure compared with the pre-procedure value, in the absence of another identified bleeding source to account for the hemoglobin drop.
3. Need for transfusion of packed red blood cells for procedure-related bleeding while in the study.

The secondary endpoints of this study will be: 1) The need to perform subsequent procedures (angiography, embolization, additional imaging study including computerized tomography (CT) scan, surgery) to diagnose or to arrest procedure-related bleeding OR the need for subsequent medical therapies (FFP, coagulation factor concentrates, anti-fibrinolytics) to treat procedure-related bleeding between time of procedure and the end of patient's time in the study. If necessary, the relationship of procedure or therapy to procedure-related bleeding will be assessed by an adjudication panel; 2) The predictive value of INR; 3) The effect of study treatment on change in INR; 4) The cost of preventing one bleed; 5) The predictors of bleeding other than INR; 6) The number of transfusion-associated adverse events encountered to prevent one bleed; and 7) The effect of treatment on bleeding grade.

Conditions

• Blood Coagulation Disorders

Interventions

PROCEDURE

FFP Infusion

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Transfusion Medicine/Hemostasis Clinical Research Network

  collaborator NETWORK

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Susan Assmann, PhD · New England Research Institutes, Inc.

• Mark Brecher, MD · University of North Carolina Hospital

• George Buchanan, MD · University of Texas SW Medical Center

• James Bussel, MD · Weill Medical College of Cornell University

• John Hess, MD, MPH · University of Maryland, Baltimore

• Christopher D. Hillyer, MD · Emory University

• Barbara Konkle, MD · University of Pennsylvania

• David Kuter, MD · Massachusetts General Hospital

• Jeffrey McCullough, MD · University of Minnesota

• Janice McFarland, MD · Blood Center of SE Wisconsin

• Paul Ness, MD · Johns Hopkins University

• Thomas Ortel, MD, PhD · Duke University

• Sherrill J. Slichter, MD · Puget Sound Blood Center Div of Research

• Ronald Strauss, MD · University of Iowa

• Darrell Triulzi, MD · University of Pittsburgh Presbyterian and Shadyside Hospital

• James R. Stubbs, MD · Mayo Clinic

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Eligibility

Min Age

4 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-03-31

Countries

• United States

Study Locations