NCT00233246

Brief 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. 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. 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. 3.Need for transfusion of packed red blood cells for procedure-related bleeding while in the study.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

15 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2005

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
Last Updated

June 6, 2014

Status Verified

June 1, 2014

First QC Date

October 3, 2005

Last Update Submit

June 5, 2014

Conditions

Blood Coagulation Disorders

Outcome Measures

Primary Outcomes (1)

  • Clinically significant bleeding (measured 4 to 30 hours after invasive hepatobiliary procedure)

Interventions

FFP InfusionPROCEDURE

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Undergoing one of the following percutaneous abdominal or transjugular invasive procedures: liver biopsy; liver-biliary abscess drainage; biliary tree drainage; or radio-frequency ablation of hepatic tumor
  • Platelet count greater than or equal to 70,000/microliter
  • INR greater than or equal to 1.3 and less than or equal to 1.9 (must not be based on a sample drawn within 24 hours of any prior FFP treatment)
  • A PTT less than or equal to 50 sec

You may not qualify if:

  • Use of warfarin, heparin, low molecular weight heparin, or other anticoagulant therapy within 5 days of the planned procedure (exceptions: prophylactic heparin injections into central venous catheters for catheter maintenance, prophylactic heparin (standard or low-dose) for prevention of deep venous thrombosis, and/or aspirin)
  • History of severe allergic reaction to plasma products
  • Use of any of the following second-generation anti-platelet agents: abciximab, tirofiban, clopidogrel, or ticlopidine
  • Currently receiving any dialysis
  • History of clinically significant bleeding diathesis, including Hemophilia A or B, von Willebrand's Disease, or congenital Factor VII deficiency
  • Known history of a coagulation-factor inhibitor within the month prior to the procedure (In the absence of a known history, testing is not required)
  • Active major bleeding; bleeding from gastrointestinal, pulmonary, mouth/throat, genito-urinary tract, or central nervous system sites (excludes guaiac positive stool sample without gross blood or melena, minor epistaxis, minor gum bleeding, microscopic hematuria, superficial bruises, normal menses, or minor vaginal spotting)
  • Pediatric patients requiring sedation in order to undergo a post-procedure ultrasound examination
  • Already received FFP in the 24 hours before the planned invasive procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Emory University

Atlanta, Georgia, 30322, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

University of North Carolina Hospital

Chapel Hill, North Carolina, 27514, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Presbyterian and Shadyside Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Texas SW Medical Center

Dallas, Texas, 75390, United States

Location

Puget Sound Blood Center Div of Research

Seattle, Washington, 98104, United States

Location

Blood Center of SE Wisconsin

Milwaukee, Wisconsin, 53201, United States

Location

MeSH Terms

Conditions

Blood Coagulation Disorders

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Susan Assmann, PhD

    New England Research Institutes, Inc.

    PRINCIPAL INVESTIGATOR

  • Mark Brecher, MD

    University of North Carolina Hospital

    PRINCIPAL INVESTIGATOR

  • George Buchanan, MD

    University of Texas SW Medical Center

    PRINCIPAL INVESTIGATOR

  • James Bussel, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

  • John Hess, MD, MPH

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

  • Christopher D. Hillyer, MD

    Emory University

    PRINCIPAL INVESTIGATOR

  • Barbara Konkle, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • David Kuter, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

  • Jeffrey McCullough, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

  • Janice McFarland, MD

    Blood Center of SE Wisconsin

    PRINCIPAL INVESTIGATOR

  • Paul Ness, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

  • Thomas Ortel, MD, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

  • Sherrill J. Slichter, MD

    Puget Sound Blood Center Div of Research

    PRINCIPAL INVESTIGATOR

  • Ronald Strauss, MD

    University of Iowa

    PRINCIPAL INVESTIGATOR

  • Darrell Triulzi, MD

    University of Pittsburgh Presbyterian and Shadyside Hospital

    PRINCIPAL INVESTIGATOR

  • James R. Stubbs, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2005

First Posted

October 5, 2005

Study Start

March 1, 2006

Last Updated

June 6, 2014

Record last verified: 2014-06

Locations

US(15)