Management of AnticoagulationNCT00703963
Improved Time in Therapeutic Range With Patient Self-Testing of Their INR Compared to Usual Care
A study testing INRatio monitor by Hemosense in people with Management of Anticoagulation, run by Mayo Clinic at 1 site in United States.
Trial summary
Patients who receive a mechanical heart valve to replace a diseased heart valve must take an anticoagulation medicine the rest of their lives, and monitor their level of anticoagulation. Until recently, the testing of the level of anticoagulation was performed at medical laboratories or hospitals. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Management of Anticoagulation
- What is being tested?
- INRatio monitor by Hemosense
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Mar 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients that received a mechanical valve while in our hospital
- Age > 18 years
Who cannot join
- Pregnant or lactating women
- Patients that have genetic clotting disorders such as Factor 5
- Physical disabilities (for example, poor eyesight, tremor, or other neurological disability) that would prevent the patient from being able to perform finger stick blood sampling. (Patients may not be excluded for physical disabilities if a care giver is willing to learn and assist with performing patient self-testing.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improved Time in Therapeutic Range With Patient Self-Testing of Their INR Compared to Usual Care: A Randomized Controlled Trial
Patients who receive a mechanical heart valve to replace a diseased heart valve must take an anticoagulation medicine the rest of their lives, and monitor their level of anticoagulation. Until recently, the testing of the level of anticoagulation was performed at medical laboratories or hospitals.
The purpose of this study is to see if patients who test their level of anticoagulation by themselves at home and then call their doctor with the result have better control of their anticoagulation as compared to patients whose anticoagulation is checked only by their physician.
Read the detailed description
Prosthetic replacement of diseased heart valves is a routine procedure, and mechanical heart valves have excellent hemodynamic performance and durability. However, mechanical valves are thrombogenic, necessitating lifelong anticoagulation. Hazards of anticoagulation include bleeding when it is excessive or thromboembolism when the intensity of anticoagulation is below the recommended level. Monitoring the level of anticoagulation is accomplished by analyzing the International Normalized Ratio. Until recently, this was performed at medical laboratories or hospitals, but recent literature suggests that patient self-testing of oral anticoagulation improves patient compliance, medical outcomes, and quality of life.
The objective of this study is to evaluate the time in therapeutic range of patients who self-test their INR compared to patients receiving the usual care. Additionally, we will evaluate the educational components and corollaries of self-testing.
Two hundred consecutively enrolled adults, having undergone implantation of a mechanical heart valve, will be randomized to either self-testing or usual care. Those randomized to the self-testing group will undergo self-testing instruction prior to hospital dismissal. For three months after hospital discharge, subject will record their INR results obtained by self-testing or as prescribed by their primary physician. They will then submit the record of the INR results and complete a survey.
- Conditions
- Management of Anticoagulation
- Being tested
- INRatio monitor by Hemosense, Usual Care
- Keywords
- International normalized ratio (INR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INRatio monitor by HemosenseDevice
Home testing monitor to test patients INR by placing a capillary drop of blood from the finger onto a test strip. The test strip is then inserted into the INRatio point-of-care self-testing coagulometer. After approximately 2 minutes of analysis, the INR value will be presented on the meter's display.
Usual CareOther
Usual care is defined as that care currently received by patients into whom mechanical heart valves are placed. Typically, these patients undergo frequent checks of their INR level until the therapeutic range is achieved. Then periodic INR levels are drawn at the discretion of the managing physician.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Subjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital. Receives: Other: Usual Care |
| Patient Self Testing | Active comparator | Subjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital. Receives: Device: INRatio monitor by Hemosense |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percentage of Time in Therapeutic Range
Measured: baseline to 3 months
Secondary outcomes (2)
Mean Percentage of INR Tests Within the Therapeutic Range
Measured: baseline to 3 months
Mean Number of INR Tests Performed
Measured: baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2008 (estimated)
- Study startMar 2007
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Management of AnticoagulationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- LivaNova
- Responsible party
- Principal investigator, Hartzell V. Schaff, Mayo Clinic
- Investigators
- Hartzell V Schaff, M.D. CS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00703963
- Sponsor's protocol ID
- 07-001398
- Status last verified
- Aug 2014
- First submitted
- 10 Jun 2008
- Last updated
- 28 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Thompson JL, Burkhart HM, Daly RC, Dearani JA, Joyce LD, Suri RM, Schaff HV. Anticoagulation early after mechanical valve replacement: improved management with patient self-testing. J Thorac Cardiovasc Surg. 2013 Sep;146(3):599-604. doi: 10.1016/j.jtcvs.2012.03.088. Epub 2012 Aug 24.
PubMed 22921821
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Time in Therapeutic Range With Patient Self-Testing of Their INR Compared to Usual Care: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00703963
- Acronym / sponsor ID
- 07-001398
- Conditions
- Management of Anticoagulation
- Keywords
- International normalized ratio (INR)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- LivaNova
- Study start
- Mar 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 24 Jun 2008 (estimated)
- Results
- Posted 28 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients who receive a mechanical heart valve to replace a diseased heart valve must take an anticoagulation medicine the rest of their lives, and monitor their level of anticoagulation. Until recently, the testing of the level of anticoagulation was performed at medical laboratories or hospitals.
The purpose of this study is to see if patients who test their level of anticoagulation by themselves at home and then call their doctor with the result have better control of their anticoagulation as compared to patients whose anticoagulation is checked only by their physician.
Detailed description
Prosthetic replacement of diseased heart valves is a routine procedure, and mechanical heart valves have excellent hemodynamic performance and durability. However, mechanical valves are thrombogenic, necessitating lifelong anticoagulation. Hazards of anticoagulation include bleeding when it is excessive or thromboembolism when the intensity of anticoagulation is below the recommended level. Monitoring the level of anticoagulation is accomplished by analyzing the International Normalized Ratio. Until recently, this was performed at medical laboratories or hospitals, but recent literature suggests that patient self-testing of oral anticoagulation improves patient compliance, medical outcomes, and quality of life.
The objective of this study is to evaluate the time in therapeutic range of patients who self-test their INR compared to patients receiving the usual care. Additionally, we will evaluate the educational components and corollaries of self-testing.
Two hundred consecutively enrolled adults, having undergone implantation of a mechanical heart valve, will be randomized to either self-testing or usual care. Those randomized to the self-testing group will undergo self-testing instruction prior to hospital dismissal. For three months after hospital discharge, subject will record their INR results obtained by self-testing or as prescribed by their primary physician. They will then submit the record of the INR results and complete a survey.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Other: Usual CareSubjects will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital. |
| Patient Self Testing | Active comparator | Device: INRatio monitor by HemosenseSubjects will be testing their INR at home using an FDA approved device (INRatio monitor by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number; their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients that received a mechanical valve while in our hospital
- Age > 18 years
Key exclusion criteria (3 listed)
- Pregnant or lactating women
- Patients that have genetic clotting disorders such as Factor 5
- Physical disabilities (for example, poor eyesight, tremor, or other neurological disability) that would prevent the patient from being able to perform finger stick blood sampling. (Patients may not be excluded for physical disabilities if a care giver is willing to learn and assist with performing patient self-testing.)
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 |
|---|---|---|
| INRatio monitor by HemosenseHome testing monitor to test patients INR by placing a capillary drop of blood from the finger onto a test strip. The test strip is then inserted into the INRatio point-of-care self-testing coagulometer. After approximately 2 minutes of analysis, the INR value will be presented on the meter's display. | Device | Patient Self Testing |
| Usual CareUsual care is defined as that care currently received by patients into whom mechanical heart valves are placed. Typically, these patients undergo frequent checks of their INR level until the therapeutic range is achieved. Then periodic INR levels are drawn at the discretion of the managing physician. | Other | Usual Care |
Primary outcome
Mean Percentage of Time in Therapeutic Range
Time frame: baseline to 3 months
2 secondary outcomes
Mean Percentage of INR Tests Within the Therapeutic Range
Time frame: baseline to 3 months
Mean Number of INR Tests Performed
Time frame: baseline to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22921821Thompson JL, Burkhart HM, Daly RC, Dearani JA, Joyce LD, Suri RM, Schaff HV. Anticoagulation early after mechanical valve replacement: improved management with patient self-testing. J Thorac Cardiovasc Surg. 2013 Sep;146(3):599-604. doi: 10.1016/j.jtcvs.2012.03.088. Epub 2012 Aug 24.
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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.
Hartzell V Schaff, M.D. CS principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INRatio monitor by Hemosense in people with Management of Anticoagulation, run by Mayo Clinic 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 28 Aug 2014. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Percentage of Time in Therapeutic Range (time frame: baseline to 3 months). 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 NCT00703963, 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 28 Aug 2014.