Pulmonary Embolism (Diagnosis)NCT06648837
Microvisk Continuous Blood Donation Study
A study testing Venepuncture and Collection of relevant information in people with Pulmonary Embolism (Diagnosis) and Deep Vein Thrombosis, run by Microvisk Technologies Ltd at 1 site in United Kingdom.
Trial summary
Microvisk Technologies Ltd designs and develops test systems for monitoring the effectiveness of Warfarin and Warfarin-like medications. Warfarin and Warfarin-like medications are used to reduce the risk of stroke in people with an irregular heart rhythm (Atrial Fibrillation) or with mechanical heart valve… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism (Diagnosis), Deep Vein Thrombosis, Atrial Fibrillation (AF)
- What is being tested?
- Venepuncture and Collection of relevant information
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Jan 2025to 1 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently undergoing Warfarin therapy.
- Over 18 years old
Who cannot join
- A participant is not eligible for participation if ANY of the following criteria are met:
- Participant is <18 years of age
- Participant is unable to give consent
- Participant has been treated with Unfractionated Heparin, or Low Molecular Weight Heparin, within the last 7 days
- Participant has, or is suspected of having, Anti-Phospholipid Syndrome (APS)
- Participant is pregnant, or has been in the past 12 months
- Participant is known to have HIV/AIDS, is a carrier of Hepatitis A, B or C, has had tuberculosis or a tropical disease
- Participant is suspected of intravenous drug use
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Oxford Haemophilia and Thrombosis Centre
Oxford, Oxfordshire, OX3 7LD
Susan Shapiro, 01865225316, susie.shapiro@ouh.nhs.uk
Chris Deane, 01865 225343, Christopher.Deane@ouh.nhs.uk
About this study
Official title: Continuous Blood Donation for the Development of the Microvisk PT/INR
Microvisk Technologies Ltd designs and develops test systems for monitoring the effectiveness of Warfarin and Warfarin-like medications.
Warfarin and Warfarin-like medications are used to reduce the risk of stroke in people with an irregular heart rhythm (Atrial Fibrillation) or with mechanical heart valve replacements, as well as reducing the risk of recurrent Venous Thromboembolism.
Read more
Warfarin dosing needs to be individualized. In order to correctly dose an individual in order to optimize the effectiveness of warfarin, and minimize the risk of bleeding, close monitoring of the degree of anticoagulation is required through regular blood testing. This test is known as PT/INR (Prothrombin Time/International Normalised Ratio). Simply, it is the measure of the amount of time (in seconds) it takes for your blood to clot.
Microvisk Technologies Ltd are developing new anticoagulant test strips for patients on warfarin or warfarin like medications. The blood collected as part of this study will be tested upon Microvisk's second generation Prothrombin/International Normalized Ratio (PT/INR) Test System. The donated blood will be used on ongoing development, validation, verification, and calibration projects. This study is being performed in partnership with the Oxford University Hospital (OUH) and Local Clinical Research Networks (LCRN) Thames Valley Core team, part of National Institute for Health and Care Research (NIHR).
Read the detailed description
The number of patients receiving anticoagulation therapy with warfarin and other vitamin K antagonists has been rising in recent years. Increasing life expectancy is increasing the proportion of the population having conditions such as Atrial Fibrillation and venous thrombosis, where primary and secondary prevention of thromboembolic complications are best achieved with anticoagulation.
Unpredictable pharmacokinetics, widespread interactions with drugs and food and the narrow therapeutic window make closely monitoring Vitamin K antagonists a necessity. Portable point of care (POC) coagulometers which measure PT from capillary whole blood and provide an INR reading within a few minutes are already widely available throughout North American and Europe. They give comparable results when compared to laboratory based systems are popular with patients and significantly shorten the duration of clinics. In addition, the United Kingdom Department of Health has been encouraging the use of anticoagulation services in Primary Care Trusts the aim being to provide INR monitoring in community clinics and General Practice surgeries relieving pressure on hospital services and reducing inconvenience for patients.
Although coagulometers are now commercially available the Microvisk INR Testing System has been designed to have advantages, particularly in terms of test robustness, user comfort, ease of use and reduction of user error. The present trial has been designed to develop the second generation Microvisk INR Test System; blood samples will also be used to optimise manufacturing processes and verify the quality of Test Strip Lots.
- Being tested
- Venepuncture, Collection of relevant information
- Keywords
- PT, INR, PT/INR, Warfarin, Vitamin K agonist, POC testing
- Medical subject headings
- Pulmonary Embolism, Disease, Venous Thrombosis, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenepunctureProcedure or surgery
Venepuncture to collect blood samples from Patients undergoing Warfarin Therapy, additional tubes of blood drawn during normal clinical vist.
Collection of relevant informationOther
Collect relevant information to ensure potential participant meets all inclusion/exclusion criteria.
| Study group | Role | What they receive |
|---|---|---|
| Warfarin patients | Experimental | Single Arm - blood collection by venepuncture in patients undergoing Warfarin Therapy Receives: Procedure: Venepuncture; Other: Collection of relevant information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing development of Microvisk Technologies PT/INR products
The Primary Outcome will be measured in terms of differences in International Normalised Ratio when the Generation 2 CoagMax system is tested against the lab benchtop analyser using the blood samples from the same donors.
Those differences will be reported in terms of accuracy, precision and sensitivity to interferents.
Measured: 5 years
Secondary outcomes (1)
The Secondary Outcome will be measured in terms of differences in International Normalised Ratio when the Generation 2 system is tested against the International Standard Method using the blood samples from the same donors.
A master batch of test strips will be calibrated against an International Reference Preparation (rTF/09) thromboplastin. The accuracy of the master batch will be verified using patient samples.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start13 Jan 2025 (estimated)
- Primary completion30 Oct 2029 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Embolism (Diagnosis)Studies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Microvisk Technologies Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susan Shapiro, Principal investigator, Oxford Haemophilia and Thrombosis Centre Oxford University Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06648837
- Sponsor's protocol ID
- PJP-R-0005
- Status last verified
- Oct 2024
- First submitted
- 15 Oct 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Blood Donation for the Development of the Microvisk PT/INR
- ClinicalTrials.gov ID
- NCT06648837
- Acronym / sponsor ID
- PJP-R-0005
- Keywords
- PT, INR, PT/INR, Warfarin, Vitamin K agonist, POC testing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Microvisk Technologies LtdIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2025 (estimated)
- Primary completion
- 30 Oct 2029 (estimated)
- Study completion
- 1 Nov 2029 (estimated)
- First posted
- 18 Oct 2024 (actual)
- 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.
Microvisk Technologies Ltd designs and develops test systems for monitoring the effectiveness of Warfarin and Warfarin-like medications.
Warfarin and Warfarin-like medications are used to reduce the risk of stroke in people with an irregular heart rhythm (Atrial Fibrillation) or with mechanical heart valve replacements, as well as reducing the risk of recurrent Venous Thromboembolism.
Warfarin dosing needs to be individualized. In order to correctly dose an individual in order to optimize the effectiveness of warfarin, and minimize the risk of bleeding, close monitoring of the degree of anticoagulation is required through regular blood testing. This test is known as PT/INR (Prothrombin Time/International Normalised Ratio). Simply, it is the measure of the amount of time (in seconds) it takes for your blood to clot.
Microvisk Technologies Ltd are developing new anticoagulant test strips for patients on warfarin or warfarin like medications. The blood collected as part of this study will be tested upon Microvisk's second generation Prothrombin/International Normalized Ratio (PT/INR) Test System. The donated blood will be used on ongoing development, validation, verification, and calibration projects. This study is being performed in partnership with the Oxford University Hospital (OUH) and Local Clinical Research Networks (LCRN) Thames Valley Core team, part of National Institute for Health and Care Research (NIHR).
Detailed description
The number of patients receiving anticoagulation therapy with warfarin and other vitamin K antagonists has been rising in recent years. Increasing life expectancy is increasing the proportion of the population having conditions such as Atrial Fibrillation and venous thrombosis, where primary and secondary prevention of thromboembolic complications are best achieved with anticoagulation.
Unpredictable pharmacokinetics, widespread interactions with drugs and food and the narrow therapeutic window make closely monitoring Vitamin K antagonists a necessity. Portable point of care (POC) coagulometers which measure PT from capillary whole blood and provide an INR reading within a few minutes are already widely available throughout North American and Europe. They give comparable results when compared to laboratory based systems are popular with patients and significantly shorten the duration of clinics. In addition, the United Kingdom Department of Health has been encouraging the use of anticoagulation services in Primary Care Trusts the aim being to provide INR monitoring in community clinics and General Practice surgeries relieving pressure on hospital services and reducing inconvenience for patients.
Although coagulometers are now commercially available the Microvisk INR Testing System has been designed to have advantages, particularly in terms of test robustness, user comfort, ease of use and reduction of user error. The present trial has been designed to develop the second generation Microvisk INR Test System; blood samples will also be used to optimise manufacturing processes and verify the quality of Test Strip Lots.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Warfarin patients | Experimental | Procedure: Venepuncture, Other: Collection of relevant informationSingle Arm - blood collection by venepuncture in patients undergoing Warfarin Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Currently undergoing Warfarin therapy.
- Over 18 years old
Key exclusion criteria (8 listed)
- Participant is <18 years of age
- Participant is unable to give consent
- Participant has been treated with Unfractionated Heparin, or Low Molecular Weight Heparin, within the last 7 days
- Participant has, or is suspected of having, Anti-Phospholipid Syndrome (APS)
- Participant is pregnant, or has been in the past 12 months
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 |
|---|---|---|
| VenepunctureVenepuncture to collect blood samples from Patients undergoing Warfarin Therapy, additional tubes of blood drawn during normal clinical vist. | Procedure or surgery | Warfarin patients |
| Collection of relevant informationCollect relevant information to ensure potential participant meets all inclusion/exclusion criteria. | Other | Warfarin patients |
Primary outcome
Ongoing development of Microvisk Technologies PT/INR products
Time frame: 5 years
The Primary Outcome will be measured in terms of differences in International Normalised Ratio when the Generation 2 CoagMax system is tested against the lab benchtop analyser using the blood samples from the same donors. Those differences will be reported in terms of accuracy, precision and sensitivity to interferents.
1 secondary outcome
The Secondary Outcome will be measured in terms of differences in International Normalised Ratio when the Generation 2 system is tested against the International Standard Method using the blood samples from the same donors.
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Susan Shapiro principal investigator
Oxford Haemophilia and Thrombosis Centre Oxford University Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venepuncture and Collection of relevant information in people with Pulmonary Embolism (Diagnosis) and Deep Vein Thrombosis, run by Microvisk Technologies Ltd at 1 site in United Kingdom.
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 8 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: opening soon, as of the sponsor's last update on 21 Nov 2024. 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 Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Cust (+44 01844338276, matt.cust@microvisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing development of Microvisk Technologies PT/INR products (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2024.