ATC Study (Healthy Volunteers-Volunteers on Anticoagulants)

This study is on pause. If you want to be contacted for similar studies, you can email us at tccr@tulane.edu or join our Volunteer Research Registry using the link below:

https://medicine.tulane.edu/center-for-clinical-research/volunteer-rese…

Study Status

Paused

Enrollment Period

-

Eligibility Criteria

Age
Adult (18 - 64)
Older adult (65+)
Accepts Healthy Volunteers
Yes
Gender
Any

Contact Information

Tulane Center for Clinical Research
504-988-0200

Select a tab above for more information.

 

Who Qualifies for this Study?

Group 1: Healthy Volunteers

  • Age: 18 to 85 years old
  • Health status: Must be healthy (i.e., no known clotting disorders or current anticoagulant use)
  • Number needed: 100 participants
  • Purpose: Used to establish normal reference values and test for hypercoagulable simulations (with added fibrinogen or tPA)

 

Group 2: Anticoagulant Users

  • Age: 18 to 85 years old
  • Health status: Currently taking oral blood thinners, including:
  • Vitamin K antagonists (e.g., warfarin)
  • Low molecular weight heparin (LMWH)
  • Direct-acting oral anticoagulants (DOACs) (e.g., apixaban, rivaroxaban, dabigatran)
  • Number needed: 50 participants
  • Purpose: Used to compare clotting data from finger-prick samples with standard venous draws in a hypocoagulable population
PI Initiated (D. Khismatullin and A Drouin)

Title

Comparative analysis of peripheral venous and capillary blood by acoustic tweezing coagulometry in healthy participants and participants treated with oral anticoagulants. 

This study aims to correlate clinical laboratory coagulation tests (PT, APTT, TT, Fibrinogen, D-Dimer) with coagulation tests performed by the ATC of whole blood [and platelet poor plasma] collected by venipuncture. Aim 1b:  To correlate ATC coagulation tests of whole blood [and platelet poor plasma] collected by venipuncture with ATC coagulation tests of whole blood collected by finger prick. Aim 2a: To standardize the ATC for coagulation measurements of capillary blood. Normal reference values for ATC coagulation parameters will be obtained from measurements of capillary blood samples collected from healthy volunteers. Capillary blood samples collected from patients on anticoagulant therapy will be used to test the validity of the normal reference values (in the limit of the hypo-coagulable state). Capillary blood samples from healthy volunteers will also be spiked with different concentration of fibrinogen and tissue plasminogen activator (tPA) to test the normal reference range validity in the limit of hyper-coagulable state. Two groups of participants are needed for this study: 1) a group of healthy subjects, 18 to 85 years old, 100 participants, and 2) a group of anticoagulant subjects with oral blood thinners such as Vitamin K antagonists, low molecular weight heparin (LMWH), and direct-acting oral anticoagulants (DOACs), 18 to 85 years old, 50 participants. 

Study Overview

This study is being done to determine if testing the blood's ability to clot using the Acoustic Tweezing Coagulometry (ATC) will correlate with coagulation testing using a venous sample collected via venipuncture. Healthy volunteers will assist with standardization of coagulation values by the ATC method to determine normal reference ranges. The study will enroll 100 healthy volunteers and 50 volunteers with chronic illness and who are taking anticoagulation medications. It will involve a total of 3 visits. Blood will be collected by venipuncture as well as fingerstick. 

Conditions / Diseases

Blood clotting

Department / Organizations

Tulane Center for Clinical Research (TCCR)

Principal Investigator

Damir Khismatullin

ClinicalTrials.gov

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