Blood Collection Device Validation for Patients on Blood Thinners

Not currently recruiting at 1 trial location

Age: Any Age

Sex:

Trial Phase: Academic

Must be taking: Anticoagulants

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to validate a new line of blood collection tubes to address shortages in healthcare facilities. Participants will assist a medical device company in obtaining FDA approval for these tubes, potentially increasing their market availability. The trial seeks individuals who regularly take blood thinners such as Pradaxa® or Xarelto® and can travel to a lab for a blood draw. Participants will receive compensation for their time and effort. As an unphased trial, participants can contribute to innovative solutions that may enhance healthcare resources.

Will I have to stop taking my current medications?

No, you will not have to stop taking your current medications. The trial specifically looks for participants who are currently on anticoagulants (blood thinners).

What prior data suggests that this blood collection device is safe for patients on blood thinners?

Research has shown that blood collection tubes are generally safe for use. Medical labs commonly use these tubes to collect blood for tests. Specific safety data regarding their use with blood thinners like Pradaxa®, Xarelto®, or Eliquis® is not available. However, these tubes are widely used without known safety issues.

This trial does not test a new drug or treatment but focuses on blood collection tubes, which are standard tools in healthcare. The goal is to ensure these tubes function effectively even when patients take blood thinners. Since blood thinners can increase bleeding risk, it is crucial to confirm the tubes' safety with these medications.

In summary, although direct safety data from past studies on using blood collection tubes with blood thinners is lacking, these tubes remain a common and well-accepted part of medical testing.

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new method for blood collection in patients taking blood thinners like Warfarin or Low Molecular Weight Heparin. The blood collection tubes being tested could potentially offer a more reliable and accurate way to measure blood levels in these patients. Unlike traditional blood collection methods that may be affected by anticoagulants, these new tubes are designed to minimize interference, leading to better monitoring and management of patients on blood thinners. This innovation could enhance safety and treatment efficacy, making it a promising advance in patient care.

What evidence suggests that this blood collection device is effective for patients on blood thinners?

This study focuses on ensuring that blood collection tubes function effectively for individuals on blood thinners. Although these tubes are not a treatment, research has shown that reliable blood collection is vital for accurate medical tests. Accurate tests are crucial for managing conditions requiring blood thinners. The goal is to ensure these tubes perform as expected, allowing doctors to trust blood test results.

Additionally, this trial addresses a shortage by approving more tubes for use. This step is important in ensuring everyone can access the tests they need.

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are taking blood thinners like Pradaxa®, Xarelto®, Eliquis®, Coumadin®, Normiflo ®, Fragmin®, or Lovenox®. Participants need to be able to travel to a lab for a blood draw.

Inclusion Criteria

I am currently taking blood thinners like Pradaxa, Xarelto, or Coumadin.

I can travel to a lab for blood tests.

I am taking Warfarin or Low Molecular Weight Heparin.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Blood Collection

Participants undergo a blood draw to test the new blood collection tubes

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any adverse reactions following the blood draw

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Blood Collection Tubes

Trial Overview The study aims to validate new blood collection tubes by drawing about 3.5 tablespoons of blood from participants on anticoagulants, helping address the shortage of these tubes in healthcare.

How Is the Trial Designed?

Group I: Participants Placebo Group 1 Intervention

Anyone on Warfarin or Low Molecular Weight Heparin

Published Research Related to This Trial

A study comparing blood collection methods found that both manual agitation with a scale and automated monitors produced equivalent results in terms of blood volume accuracy and quality of blood products, with no products failing quality control.

Automated blood collection devices were found to be more expensive and faced practical challenges, suggesting that manual methods may be just as effective and more cost-efficient for blood collection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparative validation of manual and automated methods for mixing and volume control of total blood samples]. Folléa, G., Bigey, F., Jacob, D., et al.[2019]

Proper blood sample collection and handling are critical for reliable test results, especially for clot-based tests, which require specific techniques to avoid issues like prolonged venous stasis and hemolysis.

Underfilling blood collection tubes can lead to significant biases in test results, with specific fill percentages identified for accurate coagulation testing: 89% for activated partial thromboplastin time, 78% for fibrinogen, and 67% for coagulation factor VIII.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality standards for sample collection in coagulation testing. Lippi, G., Salvagno, GL., Montagnana, M., et al.[2022]

A new smartphone-based device for measuring INR levels from whole blood samples offers a low-cost and portable solution for monitoring blood coagulation, which is crucial for patients on blood-thinning medications.

The device has been tested with both control and clinical blood samples, showing high accuracy and reliability, which could lead to improved patient outcomes through more frequent and convenient monitoring of coagulation status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Foldable low-cost point-of-care device for testing blood coagulation using smartphones. Xu, W., Althumayri, M., Mohammad, A., et al.[2023]

The new blood sampling device was evaluated with 60 blood units and found to be comparable in quality to the traditional 'cut and drip' method, while also allowing for quicker donor sample collection without affecting blood unit collection time.

The device improved safety and standardization by using vacuum tubes, ensuring sterility and eliminating reported needle-stick incidents among phlebotomists, thus enhancing the overall blood donation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SampLink: a new system for the collection of donor blood samples. Shinar, E., Michlin, H.[2019]

A study involving healthy volunteers compared traditional coagulation assays (bleeding time and light transmission aggregometry) with three point-of-care devices (Multiplate®, Platelet Function Analyzer-100®, and VerifyNow®) to assess platelet function after treatment with aspirin or clopidogrel.

The point-of-care devices demonstrated equal or greater effectiveness in quantifying platelet aggregation compared to traditional methods, suggesting they are reliable and easier alternatives for clinical drug development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized clinical trial comparing point-of-care platelet function assays and bleeding time in healthy subjects treated with aspirin or clopidogrel. Chen, F., Maridakis, V., O'neill, EA., et al.[2018]

The HemaSpot™ blood collection device shows strong accuracy in measuring HbA1c levels, with results from dried blood spots correlating well with traditional venous blood samples, based on a study of 128 adults with diabetes.

Patient acceptance is high, with 69.2% of participants expressing willingness to use the HemaSpot system, indicating it could be a convenient alternative for blood glucose monitoring, especially for those unable to visit clinics regularly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HbA1c determination from HemaSpot™ blood collection devices: comparison of home prepared dried blood spots with standard venous blood analysis. Hall, JM., Fowler, CF., Barrett, F., et al.[2022]

Citations