Blood Coagulation DisorderPhase 1NCT00288808
Comparison Between Point of Care Device and Venous Blood International Normalized Ratio Measurements.
A Phase 1 study testing Hemosense (PT/InR point of care device) in people with Blood Coagulation Disorder, run by University of Rochester at 1 site in United States.
Trial summary
Investigate the validity of Hemosense System in pediatric patients on anticoagulation therapy. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Blood Coagulation Disorder
- What is being tested?
- Hemosense (PT/InR point of care device)
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Jun 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All pediatric patient requiring Warfarin therapy.
Who cannot join
- Subjects older then 18 year of age.
- Pregnant subjects.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Strong Medical Center
Rochester, New York, 14642
About this study
Official title: Comparison Between Point of Care Device and Venous Blood International Normalized Ratio Measurements for Pediatric Patients on Anticoagulation Therapy.
Investigate the validity of Hemosense System in pediatric patients on anticoagulation therapy.
Read the 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.
- Conditions
- Blood Coagulation Disorder
- Being tested
- Hemosense (PT/InR point of care device)
- Keywords
- Blood, Coagulation, PT/InR, Warfarin, Mechanical Valve
- Medical subject headings
- Blood Coagulation Disorders, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemosense (PT/InR point of care device)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
The compariative accuracy between Point of Care device and standard of care method of determining PT/InR (Laboratory testing using Venous blood Draw)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2006 (estimated)
- Study startOct 2005
- Primary completionJun 2006
- Study completionJun 2006
Why it stopped: insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood Coagulation DisorderStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Investigators
- Peter H Chang, D.O., Principal investigator, University of Rochester Strong Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00288808
- Sponsor's protocol ID
- 11787
- Status last verified
- Apr 2015
- First submitted
- 6 Feb 2006
- Last updated
- 27 Apr 2015
- Results posted
- No
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.
PubMed 11805005
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Point of Care Device and Venous Blood International Normalized Ratio Measurements for Pediatric Patients on Anticoagulation Therapy.
- ClinicalTrials.gov ID
- NCT00288808
- Acronym / sponsor ID
- 11787
- Conditions
- Blood Coagulation Disorder
- Keywords
- Blood, Coagulation, PT/InR, Warfarin, Mechanical Valve
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient enrollment
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 8 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All pediatric patient requiring Warfarin therapy.
Key exclusion criteria (2 listed)
- Subjects older then 18 year of age.
- Pregnant subjects.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemosense (PT/InR point of care device) | Device | – |
Primary outcome
The compariative accuracy between Point of Care device and standard of care method of determining PT/InR (Laboratory testing using Venous blood Draw)
Results and safety
The study was stopped early (reason given: insufficient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2015.
- Background: PubMed 11805005Poller 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter H Chang, D.O. principal investigator
University of Rochester Strong Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hemosense (PT/InR point of care device) in people with Blood Coagulation Disorder, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: insufficient enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The compariative accuracy between Point of Care device and standard of care method of determining PT/InR (Laboratory testing using Venous blood Draw). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00288808, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2015.