NCT00288808

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2005

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

October 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 8, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

April 27, 2015

Status Verified

April 1, 2015

Enrollment Period

8 months

First QC Date

February 6, 2006

Last Update Submit

April 24, 2015

Conditions

Blood Coagulation Disorder

Keywords

BloodCoagulationPT/InRWarfarinMechanical Valve

Outcome Measures

Primary Outcomes (1)

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

Interventions

Hemosense (PT/InR point of care device)DEVICE

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \- All pediatric patient requiring Warfarin therapy.

You may not qualify if:

  • Subjects older then 18 year of age.
  • Pregnant subjects.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Strong Medical Center

Rochester, New York, 14642, United States

Location

Related Publications (1)

  • 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.

    PMID: 11805005BACKGROUND

MeSH Terms

Conditions

Blood Coagulation DisordersThrombosis

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Peter H Chang, D.O.

    University of Rochester Strong Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 6, 2006

First Posted

February 8, 2006

Study Start

October 1, 2005

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

April 27, 2015

Record last verified: 2015-04

Locations

US(1)