Device Validation Using Blood Samples for Thrombotic Thrombocytopenic Purpura

Recruiting at 1 trial location

Overseen By Shivam Joshi

Age: Any Age

Sex:

Trial Phase: Academic

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 validate a new diagnostic device for thrombotic thrombocytopenic purpura (TTP), a rare blood disorder. The focus is on hereditary TTP, where blood clots form in small vessels, leading to a low platelet count. Participants will provide a small blood sample to test this new device. This trial suits those diagnosed with hereditary TTP and who have very low ADAMTS13 enzyme activity. The study lasts about an hour, and participants receive $500 for their involvement. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could improve diagnostic methods for TTP.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this device is safe for use in blood sample analysis?

Previous studies have well established the safety of blood draws. These procedures are common in many medical settings and involve taking a small amount of blood, usually just a few drops, from a vein.

Research shows that blood draws are generally safe, and most people handle them well. Some might experience minor side effects like slight bruising, soreness, or dizziness, but these usually resolve quickly. Serious side effects are rare.

In this trial, participants will undergo only one blood draw, providing about 3 milliliters of blood. Given the commonality and usual safety of blood draws, the risk to participants is considered low.

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on validating a device using blood samples to better understand thrombotic thrombocytopenic purpura (TTP). Unlike traditional treatments for TTP, which typically involve plasma exchange and immunosuppressive therapy, this trial aims to enhance diagnostic accuracy and monitoring through the use of a novel device. The hope is that by improving the way TTP is diagnosed and managed, patients can receive more timely and precise treatments, potentially leading to better outcomes. This approach could revolutionize how TTP is monitored, making it a promising development in the field.

What evidence suggests that this device is effective for thrombotic thrombocytopenic purpura?

This trial does not test a treatment. Instead, it collects blood samples from individuals with hereditary thrombotic thrombocytopenic purpura (hTTP). The purpose is to use these samples to verify the proper functioning of a new diagnostic device. The study focuses on ensuring the device provides accurate results with known blood samples. The company behind this device already offers other similar devices. Although this is not a treatment for hTTP, it is an important step in ensuring the reliability of future diagnostic tools.

Are You a Good Fit for This Trial?

This trial is for individuals with hereditary thrombotic thrombocytopenic purpura (hTTP) who have an ADAMTS13 activity level below 1%. Participants will provide a small blood sample and receive $500 for their time.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Blood Draw

Participants complete a single blood draw for device validation

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for any immediate adverse reactions post blood draw

1 day

What Are the Treatments Tested in This Trial?

Interventions

• Blood Draw

Trial Overview The study involves a single blood draw to help validate a new diagnostic device. The company behind this has other devices on the market, and needs real patient samples to ensure the new instrument works correctly.

How Is the Trial Designed?

Group I: Participants Placebo Group 1 Intervention

Anyone with Hereditary TTP

Published Research Related to This Trial

The in vitro thrombosis model is a valuable tool for studying platelet thrombus formation, effectively simulating the four main stages of this process under various blood flow conditions.

While the model is simple and reproducible, it is important to standardize factors like collagen source and flow conditions to ensure reliable results in assessing platelet function and the effectiveness of anti-platelet therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro flow based systems to study platelet function and thrombus formation: Recommendations for standardization: Communication from the SSC on Biorheology of the ISTH. Mangin, PH., Gardiner, EE., Nesbitt, WS., et al.[2023]

A new blood collection and processing system developed for the ARIC Study showed significantly lower values of certain hemostatic factors compared to standard procedures, indicating its potential for more accurate measurements.

The system demonstrated reliability in preserving hemostatic values during temporary storage and shipping, making it suitable for multicenter clinical trials and epidemiological studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ARIC hemostasis study--I. Development of a blood collection and processing system suitable for multicenter hemostatic studies. Papp, AC., Hatzakis, H., Bracey, A., et al.[2021]

Blood assays can provide valuable insights into the activity of the hemostatic system, but the accuracy of the results heavily relies on careful sample collection and processing.

These assays are not suitable for diagnosing thrombosis; instead, they should be used primarily for studying the underlying mechanisms of thrombotic processes due to their high sensitivity and specificity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood tests for the detection of thrombosis. Effects of blood flow and location of the sampling site. Owen, J., Kaplan, KL.[2019]

Microfluidic point-of-care diagnostics can test whole blood under realistic conditions, allowing for the assessment of platelet function and coagulation in less than 1 mL of blood, which is particularly useful in emergency situations.

These devices can detect platelet inhibitors and direct oral anticoagulants (DOACs), making them suitable for rapid testing in neonatal surgeries and other high-risk scenarios involving bleeding or thrombosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Point of care whole blood microfluidics for detecting and managing thrombotic and bleeding risks. Diamond, SL., Rossi, JM.[2023]

The TEG6s system, a new point-of-care device for assessing hemostasis, shows strong correlation and comparable reference ranges with the established TEG5000 system, making it a reliable alternative for monitoring blood clotting.

TEG6s demonstrated low variability in precision testing (CV 0-13%) and offers greater ease of use, suggesting it could enhance personalized therapy in patients to minimize bleeding and thrombosis risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First report of the point-of-care TEG: A technical validation study of the TEG-6S system. Gurbel, PA., Bliden, KP., Tantry, US., 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 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]

A study involving 10 volunteers tested different centrifuge times (1, 2, 5, 10, and 15 minutes) for blood samples and found that shorter centrifuge times (5-10 minutes) can effectively reduce processing time without significantly compromising the quality of coagulation test results.

Centrifugation for 5 minutes was determined to be a suitable minimum time for routine coagulation testing, as significant variations in test results were observed only at shorter times, particularly for fibrinogen and activated partial thromboplastin time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of the centrifuge time of primary plasma tubes on routine coagulation testing. Lippi, G., Salvagno, GL., Montagnana, M., 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]

Citations