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

Sponsors and Collaborators:	National Heart, Lung, and Blood Institute (NHLBI) Transfusion Medicine/Hemostasis Clinical Research Network
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00233246

Purpose

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:

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.
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.
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.

Condition	Intervention	Phase
Blood Coagulation Disorders	Procedure: FFP Infusion	Phase III

Genetics Home Reference related topics: hemophilia

MedlinePlus related topics: Bleeding Disorders Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Placebo Control
Official Title:	Study of Hemostasis and Invasive Procedures (SHIP: A TMH CTN Study)

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:

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

Estimated Enrollment:	1300
Study Start Date:	March 2006

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Eligibility

Ages Eligible for Study:	4 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233246

Locations

United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10021
United States, North Carolina
University of North Carolina Hospital
Chapel Hill, North Carolina, United States, 27514
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Presbyterian and Shadyside Hospital
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
University of Texas SW Medical Center
Dallas, Texas, United States, 75390
United States, Washington
Puget Sound Blood Center Div of Research
Seattle, Washington, United States, 98104
United States, Wisconsin
Blood Center of SE Wisconsin
Milwaukee, Wisconsin, United States, 53201

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Transfusion Medicine/Hemostasis Clinical Research Network

Investigators

Principal Investigator:	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 Medical Center
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

More Information

No publications provided

Study ID Numbers:	326, U01 HL72028, U01 HL72072, U01 HL72191, U01 HL72196, U01 HL72248, U01 HL72289, U01 HL72290, U01 HL72291, U01 HL72299, U01 HL72305, U01 HL72331, U01 HL72346, U01 HL72355, U01 HL72359, U01 HL072283
Study First Received:	October 3, 2005
Last Updated:	December 20, 2006
ClinicalTrials.gov Identifier:	NCT00233246 History of Changes
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Hemorrhagic Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases

Hemorrhage
Hemostatic Disorders
Hemostatics

Additional relevant MeSH terms:

Hemorrhagic Disorders
Hematologic Diseases
Blood Coagulation Disorders

Vascular Diseases
Cardiovascular Diseases
Hemostatic Disorders

ClinicalTrials.gov processed this record on May 07, 2009