Blood Collection Device Validation for Patients Taking Blood Thinners
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?
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
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Blood Collection
Participants undergo a blood draw to test the new blood collection tubes
Follow-up
Participants are monitored for any adverse reactions following the blood draw
Treatment Details
Interventions
- Blood Draw