Device Validation Using Blood Samples for Thrombotic Thrombocytopenic Purpura

Recruiting in Palo Alto (17 mi)

+1 other location

Age: Any Age

Sex:

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

No Placebo Group

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

We're seeking patients with hereditary thrombotic thrombocytopenic purpura (hTTP) to complete a single blood draw in exchagne for $500. Expected duration: 1 hour. A device company that has several hemostasis and acute care in vitro diagnostic devices and products on the market. In order to bring a new instrument to market, it needs to be validated with known samples. We are looking for approximately 3 ml of whole blood from individuals diagnosed with hereditary TTP. Participants will be compensated for their time and resources.

Will I have to stop taking my current medications?

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

Is blood sample collection safe for humans?

Blood sample collection, also known as venipuncture or phlebotomy, is generally safe when proper techniques and equipment are used. Studies show that using appropriate devices and following correct procedures can ensure safety and quality in blood collection, with no significant safety issues reported for phlebotomists or donors. ^{1 2 3 4 5}

How does this treatment for Thrombotic Thrombocytopenic Purpura differ from other treatments?

This treatment involves using a device to validate blood samples for Thrombotic Thrombocytopenic Purpura, which is unique because it focuses on assessing platelet function and thrombus formation using advanced microfluidic technology. Unlike traditional methods, this approach allows for rapid and precise testing with small blood samples, potentially offering more immediate and accurate insights into the condition. ^{4 6 7 8 9}

Research Team

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Blood Draw (Procedure)

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.

Participant Groups

Group I: Participants Placebo Group 1 Intervention

Anyone with Hereditary TTP

Findings from Research

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]

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]

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]

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]

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]

References

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

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

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

Effect of venipuncture quality on thromboelastography. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Influence of the centrifuge time of primary plasma tubes on routine coagulation testing. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

ARIC hemostasis study--I. Development of a blood collection and processing system suitable for multicenter hemostatic studies. [2021]

5. England pubmed.ncbi.nlm.nih.gov

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

6. England 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. [2023]

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

Blood tests for the detection of thrombosis. Effects of blood flow and location of the sampling site. [2019]

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

Point of care whole blood microfluidics for detecting and managing thrombotic and bleeding risks. [2023]

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

First report of the point-of-care TEG: A technical validation study of the TEG-6S system. [2022]