Variability of Whole Blood Clotting Time Measurements in Ex Vivo Human Blood Samples Spiked With Anticoagulants
|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: NCT03296982|
Recruitment Status : Completed
First Posted : September 29, 2017
Last Update Posted : November 17, 2017
|Condition or disease||Intervention/treatment|
|Healthy||Other: Blood drawn by direct venipuncture Drug: edoxaban Drug: Enoxaparin Drug: Saline sham|
Twelve healthy volunteers aged 18 to 65 years (6 subjects per spiking anticoagulant) will be enrolled. A total of 8 blood samples (12 mL/sample) will be collected by direct venipuncture. The samples from will be spiked with predetermined concentrations of edoxaban or enoxaparin (baseline, saline control and 6 specified concentrations of anticoagulant).
Each blood sample will be tested for whole blood clotting time (WBCT), Point of Care activated partial thromboplastin time (aPTT) and prothrombin time (PT).
|Study Type :||Observational|
|Actual Enrollment :||12 participants|
|Official Title:||A Study to Determine the Inter/Intra Observer and Intra-Subject Variability of Whole Blood Clotting Time Measurements in Ex Vivo Human Blood Samples Spiked With Anticoagulants|
|Study Start Date :||December 2014|
|Primary Completion Date :||February 2015|
|Study Completion Date :||February 2015|
Blood will be sampled by direct venipuncture on 8 occasions.
Other: Blood drawn by direct venipuncture
Subjects will have blood sampled (12 mL/sample) a total of 8 times by direct venipuncture. Samples will be spiked with predetermined concentrations of anticoagulants, or saline sham.Drug: edoxaban Drug: Enoxaparin Drug: Saline sham
- Distribution and variability of WBCT measurements [ Time Frame: 1 day ]Assessment of the analytical measurement range, reproducibility and precision of WBCT measurement in human blood spiked with predetermined concentrations of enoxparin and edoxaban
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): NCT03296982
|Principal Investigator:||Scott Rasmussen, MD||Quintiles Phase 1 Services, LLC Overland Park KS|