Influence of Edoxaban on Coagulability and Thrombin Generation: An in Vitro Study Focusing on Thrombelastography
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02448901|
Recruitment Status : Unknown
Verified May 2015 by Paul A. Gurbel, LifeBridge Health.
Recruitment status was: Recruiting
First Posted : May 20, 2015
Last Update Posted : May 20, 2015
The influence of different doses of edoxaban on physical characteristics of the clot and thrombin generation kinetics in blood samples will be studied by in vitro spiking of blood samples collected from patients treated for heart failure (with and without hypercoagulability) and from healthy volunteers (with and without hypercoagulability). This in vitro experiment will help us to:
(i) detect qualitative anticlotting properties of edoxaban. (ii) quantify the anticlotting properties of edoxaban.
|Condition or disease||Intervention/treatment|
|Heart Failure||Drug: Edoxaban|
- On the day of experiment blood samples will be collected in 3.2% citrate tubes.
- One citrated blood tube will be centrifuged to collect plasma for biomarker measurements (C-reactive protein (CRP), fibrinogen, von Willebrand factor (vWF), interleukin (IL)-6, p-selectin, plasminogen activator inhibitor (PAI)-1, matrix metalloproteinase (MMP)-9).
- Blood samples will be incubated with different concentrations of edoxaban (no edoxaban, subtherapeutic range - 30 nM, therapeutic range -300 nM, and supratherapeutic range- 900 nM) (3).
A) Cora® Hemostasis Analyzer System (Cora®) will be used to assess qualitative and quantitative assessment of the hemostatic properties of a blood sample in the presence or absence of edoxaban. The CORA is an integrated computer module with Ethernet connection capability and provides continuous resonance-frequency viscoelasticity measurements using a disposable four-channel microfluidic cartridge to determine simultaneous maximal platelet-fibrin clot strength, fibrin clot strength, and response to antiplatelet agents or anticoagulants. The cartridge has four channels - citrated Kaolin (CK) channel that measures platelet-fibrin clot strength, anti-Xa channel, DTI channel and FFC channel that measures contribution of functional fibrinogen.
In addition, using the V-curve software, the following parameters of thrombin generation kinetics will be evaluated from the CK channel- R - Period of time of latency from the time that the blood was placed in the TEG® analyzer until the initial fibrin formation. This represents the enzymatic portion of coagulation.
K - K time is a measure of the speed to reach a certain level of clot strength. This represents clot kinetics.
alpha - measures the rapidity of fibrin build-up and cross-linking (clot strengthening). This represents fibrinogen level.
MA - Maximum Amplitude is a direct function of the maximum dynamic properties of fibrin and platelet bonding via GPIIb/IIIa and represents the ultimate strength of the fibrin clot. This represents platelet function/aggregation.
TMRTG - Time to maximum rate of thrombus generation. MRTG - Maximum rate of thrombus generation. TG - Total thrombus generated. TMRL - Time to maximum rate of lysis MRL - Maximum rate of lysis L - Total lysis D - Delta is the difference between R time and the time of initial split point (SP, mins) of the TEG tracing (R - SP), representing the time interval of greatest clot growth secondary to peak thrombin generation.
B) Calibrated Automated Thrombogram® (CAT) System: Lag time, peak thrombin production, mean velocity rate index and endogenous thrombin potential (ETP) will be assessed by calibrated automated thrombogram in platelet poor plasma (Thrombinoscope by Stago).
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Influence of Edoxaban on Coagulability and Thrombin Generation: An in Vitro Study Focusing on Thrombelastography|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||February 2016|
|Estimated Study Completion Date :||March 2016|
- Drug: Edoxaban
In vitro study. Various concentrations of Edoxoban added to blood sample and testedOther Name: DU-176b, trade names Savaysa, Lixiana
- Assessment of clot physiology of a blood sample in the presence and absence of edoxaban by point of care thrombelastography (TEG-6s) [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02448901
|Contact: Kevin P Bliden, BS, MBAfirstname.lastname@example.org|
|Contact: Udaya Tantry, PhDemail@example.com|
|United States, Maryland|
|Sinai Center for Thrombosis Research||Recruiting|
|Baltimore, Maryland, United States, 21215|
|Contact: Kevin Bliden, MBA 410-601-4795 firstname.lastname@example.org|
|Principal Investigator:||paul gurbel, MD||Sinai Center for Thrombosis Research|