Blood Collection Device Validation for Patients Taking Blood Thinners

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)

Approved in 6 Jurisdictions This treatment is already approved in other countries

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 qualify a new line of blood collection tubes to help address the shortage in the U.S. Participants will test the tubes by providing a small blood sample, which is crucial for the manufacturer to gain FDA approval. The trial seeks individuals currently taking blood thinners such as Pradaxa®, Xarelto®, or Coumadin®. Participants must travel to a lab for the blood draw (also known as phlebotomy or venipuncture). Compensation of up to $200 is offered for their time and effort. As an unphased trial, participation is vital in supporting innovative solutions to improve healthcare resources.

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

Research shows that blood draws are generally safe. This study will collect blood from individuals taking blood thinners such as Pradaxa®, Xarelto®, and Eliquis®. Although these medications can increase bleeding risk, most individuals tolerate blood draws well. No specific studies have shown problems with blood collection in these cases, indicating that issues are rare. Participants will undergo a standard blood draw, involving about 3.5 tablespoons of blood. The trial also aims to address the shortage of blood collection tubes, prioritizing safety.

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to validate a blood collection device specifically for patients on blood thinners like Warfarin or Low Molecular Weight Heparin. Current blood collection methods can be challenging for these patients due to increased bleeding risks. This trial seeks to find a safer, more efficient way to collect blood without compromising the patient's health. By improving the safety and reliability of blood draws for individuals on anticoagulants, this trial has the potential to enhance patient care and monitoring.

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

The study tests new blood collection tubes for individuals taking blood thinners. It does not evaluate a specific treatment's effectiveness. Instead, the researchers aim to ensure these new tubes function well for patients using medications like Eliquis® and Coumadin®. This is crucial due to a shortage of blood collection tubes, and labs must continue performing blood tests safely and effectively for those on blood thinners. The study focuses on the safe use of these new tubes, not on treating any medical condition.

Are You a Good Fit for This Trial?

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 currently taking blood thinners like Pradaxa, Xarelto, or similar.

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

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 Draw

Trial Overview The 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.

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 new device has been developed to enhance the safety and accuracy of venipuncture by autonomously locating and accessing veins using near-infrared imaging and computer vision, which could reduce complications associated with blood draws and IV placements.

The device has shown promising results in proof-of-concept tests, demonstrating effective imaging performance in humans and accurate needle placement on a phlebotomy training model, indicating its potential for improving clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Portable robot for autonomous venipuncture using 3D near infrared image guidance. Chen, A., Nikitczuk, K., Nikitczuk, J., et al.[2019]

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]

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 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]

In a retrospective study of adult spinal deformity surgery involving patients aged 65 and older, both those aged 65-74.9 and those 75 and older showed significant improvements in radiographic parameters and pain/disability scores over a 2-year period.

There were no significant differences in complications or the need for additional surgeries between the two age groups, suggesting that age alone does not impact the safety or efficacy of spinal deformity surgery in elderly patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adult spine deformity surgery in elderly patients: are outcomes worse in patients 75 years and older? Lovato, ZR., Deckey, DG., Chung, AS., 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]

In a study of 1843 workers with low back injuries, those prescribed opioids for more than 7 days were 2.2 times more likely to experience work disability one year later, indicating a significant risk associated with prolonged opioid use.

Over one-third of the workers received an opioid prescription within 6 weeks of their injury, and more than half of these prescriptions were given at the first medical visit, highlighting the need for careful management of pain treatment in acute back injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early opioid prescription and subsequent disability among workers with back injuries: the Disability Risk Identification Study Cohort. Franklin, GM., Stover, BD., Turner, JA., et al.[2022]

In a study of 1,068 workers with work-related back pain, 18.4% were still receiving disability compensation after 6 months, indicating a significant risk of prolonged disability.

Key predictors of chronic work disability included high levels of pain and disability, low recovery expectations, and high fear-avoidance regarding work, suggesting that addressing these psychosocial factors could be crucial in preventing long-term disability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Worker recovery expectations and fear-avoidance predict work disability in a population-based workers' compensation back pain sample. Turner, JA., Franklin, G., Fulton-Kehoe, D., et al.[2009]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of venipuncture quality on thromboelastography. Garcia-Pereira, BL., Scott, MA., Koenigshof, AM., 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]

The use of a vein-viewing device significantly improved the first-attempt success rate of venipunctures in pediatric patients, increasing from 49.3% to 80.2% based on a study of 91 patients aged newborn to 17 years.

The device also reduced the average number of attempts per patient from 1.97 to 1.29 and increased the percentage of procedures completed in 15 minutes or less from 52.8% to 86.7%, indicating enhanced efficiency and effectiveness in vascular access procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A biomedical device to improve pediatric vascular access success. Hess, HA.[2010]

In a study of 141 patients with traumatic spinal cord injuries, 50.3% experienced complications, with pressure ulcers being the most common at 29.8%, highlighting a significant concern during acute care.

Risk factors for developing pressure ulcers included having a gun-shot injury, motor completeness (AIS A│B), and vertebral injury, indicating that targeted prevention strategies are needed for these high-risk groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of secondary medical complications and risk factors for pressure ulcers after traumatic spinal cord injury during acute care in South Africa. Joseph, C., Nilsson Wikmar, L.[2022]

In a study involving 30 subjects, it was found that nurses adjusted their techniques based on blood flow during venipuncture, which could impact the risk of complications like pushing the needle through the vein.

The time taken to fill blood collection tubes varied significantly depending on the nurse's skill level and the order of the tubes, indicating that experience and technique play crucial roles in the efficiency of blood collection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vacuum-venipuncture skills: time required and importance of tube order. Fujii, C.[2021]

In a study of 96 individuals with spinal cord injury (SCI), nearly 48% required at least one intervention based on annual urodynamic evaluations, highlighting the importance of these tests in managing bladder health.

The majority of interventions were urological, primarily involving medication changes, indicating that regular urodynamic studies can significantly inform treatment decisions for individuals with SCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of annual urodynamic evaluations on guiding bladder management in individuals with spinal cord injuries. Linsenmeyer, TA., Linsenmeyer, MA.[2021]

Citations