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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.
 
ClinicalTrials.gov Identifier: NCT00288808
Recruitment Status : Terminated (insufficient enrollment)
First Posted : February 8, 2006
Last Update Posted : April 27, 2015
Sponsor:
Information provided by:
University of Rochester

Tracking Information
First Submitted Date  ICMJE February 6, 2006
First Posted Date  ICMJE February 8, 2006
Last Update Posted Date April 27, 2015
Study Start Date  ICMJE October 2005
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2006)
The compariative accuracy between Point of Care device and standard of care method of determining PT/InR (Laboratory testing using Venous blood Draw)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison Between Point of Care Device and Venous Blood International Normalized Ratio Measurements.
Official Title  ICMJE Comparison Between Point of Care Device and Venous Blood International Normalized Ratio Measurements for Pediatric Patients on Anticoagulation Therapy.
Brief Summary Investigate the validity of Hemosense System in pediatric patients on anticoagulation therapy.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Blood Coagulation Disorder
Intervention  ICMJE Device: Hemosense (PT/InR point of care device)
Study Arms  ICMJE Not Provided
Publications * Poller L, Keown M, Chauhan N, van den Besselaar AM, Meeuwisse-Braun J, Tripodi A, Clerici M, Jespersen J. European concerted action on anticoagulation. Use of plasma samples to derive international sensitivity index for whole-blood prothrombin time monitors. Clin Chem. 2002 Feb;48(2):255-60.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: February 6, 2006)
200
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2006
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

- All pediatric patient requiring Warfarin therapy.

Exclusion Criteria:

  1. Subjects older then 18 year of age.
  2. Pregnant subjects.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00288808
Other Study ID Numbers  ICMJE 11787
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Rochester
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter H Chang, D.O. University of Rochester Strong Memorial Hospital
PRS Account University of Rochester
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP