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Variability of Whole Blood Clotting Time Measurements in Ex Vivo Human Blood Samples Spiked With Anticoagulants

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ClinicalTrials.gov Identifier: NCT03296982
Recruitment Status : Completed
First Posted : September 29, 2017
Last Update Posted : November 17, 2017
Sponsor:
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
Perosphere, Inc.

Brief Summary:
The study will assess the distribution and variability of whole blood clotting time (WBCT) measurement in human blood collected from healthy volunteers that is untreated and spiked with predetermined concentrations of edoxaban or enoxaparin.

Condition or disease Intervention/treatment
Healthy Other: Blood drawn by direct venipuncture Drug: edoxaban Drug: Enoxaparin Drug: Saline sham

Detailed Description:

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
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Blood Sample
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



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
healthy volunteers
Criteria

Inclusion Criteria:

  1. Signed and dated informed consent form
  2. Healthy male and female subjects aged 18 to 65 years (inclusive) with suitable veins for venipuncture -

Exclusion Criteria:

  1. Subjects who cannot communicate reliably with the Investigator
  2. History of major bleeding or major trauma within the 6 months prior to signing informed consent
  3. Propensity to bleeding (i.e. due to recent trauma, surgery, peptic ulcer, gastrointestinal bleeding or hemorrhoids)
  4. Significant infection or known inflammatory process in the 2 weeks prior to screening
  5. Active smoker or current use of any tobacco products or use within 3 months prior to signing informed consent
  6. Treatment with any investigation product or therapy within 30 days prior to screening
  7. Received non-steroidal antiinflammatory drugs or medications (including anticoagulants or aspirin) with a direct effect on hemostasis within 7 days of blood sampling
  8. Unwilling to comply with the procedures in the protocol
  9. Currently enrolled in any other study -

Information from the National Library of Medicine

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


Sponsors and Collaborators
Perosphere, Inc.
Quintiles, Inc.
Investigators
Principal Investigator: Scott Rasmussen, MD Quintiles Phase 1 Services, LLC Overland Park KS

Responsible Party: Perosphere, Inc.
ClinicalTrials.gov Identifier: NCT03296982     History of Changes
Other Study ID Numbers: PER977-01-010
First Posted: September 29, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Perosphere, Inc.:
Whole blood clotting time

Additional relevant MeSH terms:
Embolism and Thrombosis
Thrombosis
Vascular Diseases
Cardiovascular Diseases
Edoxaban
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action