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Comparison Between Point of Care Device and Venous Blood International Normalized Ratio Measurements.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00288808
Recruitment Status : Terminated (insufficient enrollment)
First Posted : February 8, 2006
Last Update Posted : April 27, 2015
Information provided by:
University of Rochester

Brief Summary:
Investigate the validity of Hemosense System in pediatric patients on anticoagulation therapy.

Condition or disease Intervention/treatment Phase
Blood Coagulation Disorder Device: Hemosense (PT/InR point of care device) Phase 1

Detailed Description:

Over the last few decades there has been an increased use of Warfarin in the pediatric population stemming from the use of mechanical heart valves and palliative surgical procedures requiring anticoagulation therapy. Other patients with enzymatic deficiency within the coagulation cascade may develop thrombosis treated with anticoagulation, i.e. factor V Leiden deficiency. Prevention of poor outcome from thrombosis has required closer monitoring in the pediatric patient. In addition, absorption of Warfarin in the pediatric population is highly variable and depends on the child's age, weight, diet, and concurrent use of other medications (Desai, 2000). This makes achieving anticoagulation very difficult. "Because of the intrinsic differences in the coagulation systems in children and adults, guidelines for antithrombotic therapy in adults cannot be extrapolated to pediatrics" (Desai, 2000). Therefore, pediatric patients on anticoagulation therapy require frequent lab work to monitor their prothrombin time and international ratios (PT/INR).

There are a number of barriers to care when discussing anticoagulation therapy for pediatric patients. Frequent venous blood draws represent a painful procedure that elicit anxiety and fear which leads to noncompliance. In addition, children are more difficult to obtain blood samples because of smaller vessels, patient movement during procedure, and the volume of blood that is required for the test. Other barriers include the time delay from when the patient has the lab work drawn, to when the result get to the provider for any patient care decisions to be made.

There are a number of Point of Care devices available for near-patient testing of the PT/InR's that requires only a finger stick. These monitors have been validated against standardized laboratory testing, in order for the monitor to be certified by the FDA. Similar studies to validate finger stick methods in pediatric patients have not been completed. The aim of this project is to validate the accuracy of Hemosense, a point of care device, to venous blood PT/InR level in the pediatric population.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison Between Point of Care Device and Venous Blood International Normalized Ratio Measurements for Pediatric Patients on Anticoagulation Therapy.
Study Start Date : October 2005
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. The compariative accuracy between Point of Care device and standard of care method of determining PT/InR (Laboratory testing using Venous blood Draw)

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

- All pediatric patient requiring Warfarin therapy.

Exclusion Criteria:

  1. Subjects older then 18 year of age.
  2. Pregnant subjects.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00288808

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United States, New York
University of Rochester Strong Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
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Principal Investigator: Peter H Chang, D.O. University of Rochester Strong Memorial Hospital
Layout table for additonal information Identifier: NCT00288808    
Other Study ID Numbers: 11787
First Posted: February 8, 2006    Key Record Dates
Last Update Posted: April 27, 2015
Last Verified: April 2015
Keywords provided by University of Rochester:
Mechanical Valve
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders