HealthyPhase 1Aspirin-BVTNCT01047722
In-Vivo Bleeding Volume Test for Platelet-Aspirin Interaction
A Phase 1 study testing Aspirin ingestion followed by doing a Bleeding Volume Test in people with Healthy, run by Klein, Jeffrey A., M.D. at 2 sites in United States.
Trial summary
Purpose of the present research project is to study a new in-vivo test for abnormal platelet function and to study the effect of certain drugs on clinical bleeding. This is a randomized clinical trial of a new in-vivo test of platelet function known as the bleeding volume test(BVT)which relies on an on-line… Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Aspirin ingestion followed by doing a Bleeding Volume Test
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2010to Oct 2015
- 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 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult male and female
- Ages 18 to 89 years old
Who cannot join
- Any history of HIV, Hepatitis C or presence of a blood-borne infectious disease
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Private practice office
Newport Beach, California, 92660
Capistrano Surgery Center
San Juan Capistrano, California, 92675
About this study
Official title: Bleeding Volume Test: A Double-Blind Crossover Randomized Clinical Trial of an In-Vivo On-Line Test for Aspirin Effect and Resistance
Purpose of the present research project is to study a new in-vivo test for abnormal platelet function and to study the effect of certain drugs on clinical bleeding. This is a randomized clinical trial of a new in-vivo test of platelet function known as the bleeding volume test(BVT)which relies on an on-line measurement system. This trial will assess the sensitivity and specificity of the new BVT by studying the effects of aspirin which is known to affect platelet function in-vivo. This is not a clinical trial of drugs. This is a clinical trial of a novel in-vivo on-line laboratory test.
The BVT measures the total volume of blood in the discrete blotches of blood on the blotter paper during the BT test and thus the BVT gleans valuable additional information from the bleeding time test (BTT)procedure. We hypothesize that the BV test will be a more accurate, specific and sensitive test for diagnosing platelet function abnormalities and for detecting a person's bleeding tendency compared to the BTT, and commercially available in-vitro platelet function tests.
Read the detailed description
Purpose of the present research project is to study a new in-vivo test for abnormal platelet function and to study the effect of certain drugs on clinical bleeding. This is a randomized clinical trial of a new in-vivo test of platelet function known as the bleeding volume (BV) test which relies on an on-line measurement system. This trial will assess the sensitivity and specificity of the new BV test by studying the effects of aspirin which is known to affect platelet function in-vivo. This is not a clinical trial of drugs. This is a clinical trial of a novel laboratory test. The BV test results will be compared to the results of two commercially available platelet function tests (the VerifyNow test and the PFA-100 test) which requires 10 ml of blood taken from a peripheral vein.
The bleeding volume test is an extension of the classic Ivy Bleeding Time Test (BTT). The BTT, an in-vivo test for an abnormal bleeding tendency, involves making a small standardized cut in the skin and measuring the duration of bleeding. We hypothesize that measuring both the volume of blood lost (BV) and the BT will to provide a more useful test. The BV test is expected to provide an improved in-vivo technique for 1) investigating the effects of drugs on platelet function and 2) diagnosing diseases of abnormal platelet function such as von Willebrand disease (vWD), 3) identifying patients who are aspirin-resistant in the sense that they do not benefit from the beneficial effects of aspirin in preventing thromboembolic disease (heart attack and stroke), 4) providing insight into the effects of antithrombotic drugs such as clopidogrel, lidocaine and statins (HMG-CoA reductase inhibitors). The BV test will provide an inexpensive diagnostic test and improve patient care.
- Conditions
- Healthy
- Being tested
- Aspirin ingestion followed by doing a Bleeding Volume Test, Gatorade Placebo followed by Bleeding Volume Test.
- Keywords
- platelet function test, platelets, in vivo test, aspirin, aspirin resistance, aspirin non-responsiveness, in-vivo, To assess the specificity and sensitivity of a novel in-vivo diagnostic test of platelet function, To use this test to define and assess "aspirin resistance"
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin ingestion followed by doing a Bleeding Volume TestDrug
Patient drinks a glass of Gatorade containing 325 mg of aspirin, then one hour later a bleeding volume test is performed.
Gatorade Placebo followed by Bleeding Volume Test.Procedure or surgery
Patient drinks a glass of Gatorade, then one hour later a bleeding volume test is performed.
| Study group | Role | What they receive |
|---|---|---|
| Patient drinks aspirin in Gatorade. | Active comparator | Patient drinks Gatorade containing 325 mg aspirin. Bleeding Volume Test is done one hour later. Receives: Drug: Aspirin ingestion followed by doing a Bleeding Volume Test |
| Gatorade Placebo | Placebo comparator | Patient ingests Gatorade and one hour later a Bleeding Volume Test is performed Receives: Procedure: Gatorade Placebo followed by Bleeding Volume Test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, Specificity & ROC curve characteristics of the Bleeding Volume Test
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klein, Jeffrey A., M.D.
- Responsible party
- Principal investigator, Jeffrey Alan Klein, MD, Klein, Jeffrey A., M.D.
- Investigators
- Jeffrey A Klein, MD, Principal investigator, University of Californiia, Riverside
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047722
- Sponsor's protocol ID
- 3 BVT-ASA
- Acronym
- Aspirin-BVT
- Status last verified
- Jul 2015
- First submitted
- 12 Jan 2010
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bleeding Volume Test: A Double-Blind Crossover Randomized Clinical Trial of an In-Vivo On-Line Test for Aspirin Effect and Resistance
- ClinicalTrials.gov ID
- NCT01047722
- Acronym / sponsor ID
- Aspirin-BVT / 3 BVT-ASA
- Conditions
- Healthy
- Keywords
- platelet function test, platelets, in vivo test, aspirin, aspirin resistance, aspirin non-responsiveness, in-vivo, To assess the specificity and sensitivity of a novel in-vivo diagnostic test of platelet function
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Klein, Jeffrey A., M.D.
- Study start
- Jan 2010
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 13 Jan 2010 (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.
Purpose of the present research project is to study a new in-vivo test for abnormal platelet function and to study the effect of certain drugs on clinical bleeding. This is a randomized clinical trial of a new in-vivo test of platelet function known as the bleeding volume test(BVT)which relies on an on-line measurement system. This trial will assess the sensitivity and specificity of the new BVT by studying the effects of aspirin which is known to affect platelet function in-vivo. This is not a clinical trial of drugs. This is a clinical trial of a novel in-vivo on-line laboratory test.
The BVT measures the total volume of blood in the discrete blotches of blood on the blotter paper during the BT test and thus the BVT gleans valuable additional information from the bleeding time test (BTT)procedure. We hypothesize that the BV test will be a more accurate, specific and sensitive test for diagnosing platelet function abnormalities and for detecting a person's bleeding tendency compared to the BTT, and commercially available in-vitro platelet function tests.
Detailed description
Purpose of the present research project is to study a new in-vivo test for abnormal platelet function and to study the effect of certain drugs on clinical bleeding. This is a randomized clinical trial of a new in-vivo test of platelet function known as the bleeding volume (BV) test which relies on an on-line measurement system. This trial will assess the sensitivity and specificity of the new BV test by studying the effects of aspirin which is known to affect platelet function in-vivo. This is not a clinical trial of drugs. This is a clinical trial of a novel laboratory test. The BV test results will be compared to the results of two commercially available platelet function tests (the VerifyNow test and the PFA-100 test) which requires 10 ml of blood taken from a peripheral vein.
The bleeding volume test is an extension of the classic Ivy Bleeding Time Test (BTT). The BTT, an in-vivo test for an abnormal bleeding tendency, involves making a small standardized cut in the skin and measuring the duration of bleeding. We hypothesize that measuring both the volume of blood lost (BV) and the BT will to provide a more useful test. The BV test is expected to provide an improved in-vivo technique for 1) investigating the effects of drugs on platelet function and 2) diagnosing diseases of abnormal platelet function such as von Willebrand disease (vWD), 3) identifying patients who are aspirin-resistant in the sense that they do not benefit from the beneficial effects of aspirin in preventing thromboembolic disease (heart attack and stroke), 4) providing insight into the effects of antithrombotic drugs such as clopidogrel, lidocaine and statins (HMG-CoA reductase inhibitors). The BV test will provide an inexpensive diagnostic test and improve patient care.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient drinks aspirin in Gatorade. | Active comparator | Drug: Aspirin ingestion followed by doing a Bleeding Volume TestPatient drinks Gatorade containing 325 mg aspirin. Bleeding Volume Test is done one hour later. |
| Gatorade Placebo | Placebo comparator | Procedure: Gatorade Placebo followed by Bleeding Volume Test.Patient ingests Gatorade and one hour later a Bleeding Volume Test is performed |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult male and female
- Ages 18 to 89 years old
Key exclusion criteria (1 listed)
- Any history of HIV, Hepatitis C or presence of a blood-borne infectious disease
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 |
|---|---|---|
| Aspirin ingestion followed by doing a Bleeding Volume TestPatient drinks a glass of Gatorade containing 325 mg of aspirin, then one hour later a bleeding volume test is performed. | Drug | Patient drinks aspirin in Gatorade. |
| Gatorade Placebo followed by Bleeding Volume Test.Patient drinks a glass of Gatorade, then one hour later a bleeding volume test is performed. | Procedure or surgery | Gatorade Placebo |
Primary outcome
Sensitivity, Specificity & ROC curve characteristics of the Bleeding Volume Test
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2015.
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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.
Jeffrey A Klein, MD principal investigator
University of Californiia, Riverside
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aspirin ingestion followed by doing a Bleeding Volume Test in people with Healthy, run by Klein, Jeffrey A., M.D. at 2 sites 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 1 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: status not confirmed, as of the sponsor's last update on 21 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
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?
Sensitivity, Specificity & ROC curve characteristics of the Bleeding Volume Test (time frame: one year). 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 Jul 2015.