Blood Collection Device Validation for Patients on Blood Thinners

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

Trial Summary

What is the purpose of this trial?

Due to worldwide supply chain issues, US health care is experiencing a global shortage of blood collection tubes. The purpose of this trial is to help a medical device manufacturer qualify their line of blood collection tubes with the FDA, which will help increase the supply of blood collection tubes on the market. We are looking for participants currently on anticoagulants such as Pradaxa®, Xarelto®, Eliquis®, Coumadin®, Normiflo ®, Fragmin®, or Lovenox®. Participants are compensated for their time and resources (up to $200 for a 3.5 tablespoon blood draw).

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 data supports the effectiveness of the blood collection tubes treatment for patients on blood thinners?

The study on a novel heparin-iloprost-based blood collection tube suggests it can effectively measure important blood components, which may indicate its usefulness for patients on blood thinners. Additionally, proper blood collection techniques, as discussed in the research, are crucial for accurate test results, supporting the importance of validated blood collection devices. ^{1 2 3 4 5}

Is the blood collection device safe for use in humans, especially for those on blood thinners?

The research highlights the importance of using proper techniques and devices for blood collection to ensure safety and reliability. It suggests that using the correct blood collection tubes and following guidelines can help prevent issues like prolonged blood flow restriction and incorrect sample handling, which are important for safe blood collection. ^{1 2 3 6 7}

How does this blood collection device differ from other treatments for patients on blood thinners?

This blood collection device is unique because it uses a novel antithrombotic formulation in a single tube to measure various blood components, which may simplify the process for patients on blood thinners by reducing the need for multiple tests and tubes. ^{1 2 4 8 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Participants Placebo Group 1 Intervention

Anyone on Warfarin or Low Molecular Weight Heparin

Findings from Research

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]

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 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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of a novel heparin-iloprost-based antithrombotic formulation blood collection tube for clinical usage. [2022]

2. England pubmed.ncbi.nlm.nih.gov

HbA1c determination from HemaSpot™ blood collection devices: comparison of home prepared dried blood spots with standard venous blood analysis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Quality standards for sample collection in coagulation testing. [2022]

4. France pubmed.ncbi.nlm.nih.gov

[Comparative validation of manual and automated methods for mixing and volume control of total blood samples]. [2019]

5. England 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. [2018]

6. Germany pubmed.ncbi.nlm.nih.gov

Comparison of Improvacuter™ tubes with BD Vacutainer™ tubes for various hormones in the aspects of stability and influence of gel separators. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Citrate phosphate dextrose adenine (CPDA-1) can be sampled from blood collection bags in a multi-dose manner. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Foldable low-cost point-of-care device for testing blood coagulation using smartphones. [2023]

9. England pubmed.ncbi.nlm.nih.gov

SampLink: a new system for the collection of donor blood samples. [2019]