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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2005 by University of Rochester.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00288808
First received: February 6, 2006
Last updated: NA
Last verified: December 2005
History: No changes posted
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by University of Rochester:

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

Estimated Enrollment: 200
Study Start Date: October 2005
Estimated Study Completion Date: September 2006
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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- All pediatric patient requiring Warfarin therapy.

Exclusion Criteria:

  1. Subjects older then 18 year of age.
  2. Pregnant subjects.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00288808

Locations
United States, New York
University of Rochester Strong Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Peter H CHANG, D.O.    585-273-5440    psschang@yahoo.com   
Principal Investigator: Peter H chang, D.O.         
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Peter H Chang, D.O. University of Rochester Strong Memorial Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00288808     History of Changes
Other Study ID Numbers: 11787
Study First Received: February 6, 2006
Last Updated: February 6, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Rochester:
Blood
Coagulation
PT/InR
Warfarin
Mechanical Valve

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on September 16, 2014