Blood Collection Device Validation for Patients Taking Blood Thinners

Age: Any Age
Sex:
Trial Phase: Academic
Must be taking: Anticoagulants
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 6 JurisdictionsThis treatment is already approved in other countries

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 do not have to stop taking your current medications. The trial specifically seeks participants who are currently on anticoagulants (blood thinners).

What data supports the effectiveness of this treatment for patients taking blood thinners?

The research highlights the importance of proper venipuncture techniques and the use of appropriate devices to ensure high-quality blood samples, which is crucial for accurate testing, especially in patients on blood thinners. Proper sample collection can prevent issues like prolonged bleeding and ensure reliable test results.12345

Is blood collection safe for people on blood thinners?

Blood collection, also known as blood draw or venipuncture, is generally considered safe for most people, including those on blood thinners. However, there may be a slightly increased risk of bruising or bleeding at the site where the needle is inserted.678910

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

This blood collection device is unique because it allows patients on blood thinners to monitor their INR levels using a portable, smartphone-based system, reducing the need for frequent hospital visits. It uses a 3D printed platform and smartphone technology to provide a cost-effective and convenient option for blood coagulation monitoring at home.211121314

Eligibility Criteria

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

Inclusion Criteria

I am taking Warfarin or Low Molecular Weight Heparin.
I am 18 years old or older.
I am currently taking blood thinners like Pradaxa, Xarelto, or similar.
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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 Draw
Trial OverviewThe study aims to validate new blood collection tubes by drawing about 3.5 tablespoons of blood from participants on anticoagulants. This could help address the shortage of these tubes in US healthcare.
Participant Groups
1Treatment groups
Placebo Group
Group I: ParticipantsPlacebo Group1 Intervention
Anyone on Warfarin or Low Molecular Weight Heparin

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Findings from Research

The quality of venipuncture significantly affects thromboelastography (TEG) results, particularly the R parameter, with suboptimal venipuncture leading to a faster initiation of clot formation in dogs.
Using an initial discard tube can mitigate the effects of traumatic venipuncture, as the differences in TEG results were less pronounced in subsequent samples after discarding the first one.
Effect of venipuncture quality on thromboelastography.Garcia-Pereira, BL., Scott, MA., Koenigshof, AM., et al.[2022]
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.
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.
Quality standards for sample collection in coagulation testing.Lippi, G., Salvagno, GL., Montagnana, M., et al.[2022]

References

Effect of venipuncture quality on thromboelastography. [2022]
HbA1c determination from HemaSpot™ blood collection devices: comparison of home prepared dried blood spots with standard venous blood analysis. [2022]
Quality standards for sample collection in coagulation testing. [2022]
A biomedical device to improve pediatric vascular access success. [2010]
Vacuum-venipuncture skills: time required and importance of tube order. [2021]
Early opioid prescription and subsequent disability among workers with back injuries: the Disability Risk Identification Study Cohort. [2022]
Adult spine deformity surgery in elderly patients: are outcomes worse in patients 75 years and older? [2022]
Impact of annual urodynamic evaluations on guiding bladder management in individuals with spinal cord injuries. [2021]
Prevalence of secondary medical complications and risk factors for pressure ulcers after traumatic spinal cord injury during acute care in South Africa. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Worker recovery expectations and fear-avoidance predict work disability in a population-based workers' compensation back pain sample. [2009]
Foldable low-cost point-of-care device for testing blood coagulation using smartphones. [2023]
Portable robot for autonomous venipuncture using 3D near infrared image guidance. [2019]
[Comparative validation of manual and automated methods for mixing and volume control of total blood samples]. [2019]
SampLink: a new system for the collection of donor blood samples. [2019]