Back to resultsNOAC Plasma Concentration and Blood Coagulation in Healthy Volunteers (EdoRot)
Primary Purpose
Blood Coagulation Disorder
Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Edoxaban 60 MG
Sponsored by
About this trial
This is an interventional basic science trial for Blood Coagulation Disorder
Eligibility Criteria
Inclusion Criteria:
healthy
Exclusion Criteria:
intolerance of the study drug history of bleeding disorder or similar
Sites / Locations
- Turku University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Rotem
Arm Description
Outcomes
Primary Outcome Measures
correlation of edoxaban peak plasma concentrations and viscoelastic analysis
viscoelastic test values and blood coagulation laboratory parameters
Secondary Outcome Measures
Full Information
NCT ID
NCT03666650
First Posted
September 8, 2018
Last Updated
September 13, 2019
Sponsor
Turku University Hospital
Collaborators
Helsinki University Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03666650
Brief Title
NOAC Plasma Concentration and Blood Coagulation in Healthy Volunteers
Acronym
EdoRot
Official Title
Relationship of Edoxaban Plamsa Concentration and Blood Coagulation in Healthy Volunteers Using Standard Laboratory Tests and Viscoelastic Analysis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
November 26, 2018 (Actual)
Primary Completion Date
January 8, 2019 (Actual)
Study Completion Date
January 8, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turku University Hospital
Collaborators
Helsinki University Central Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Relationship of edoxaban plasma concentration and blood coagulation in healthy volunteers using standard laboratory tests and viscoelastic analysis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Coagulation Disorder
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rotem
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Edoxaban 60 MG
Intervention Description
Viscoelastic analysis and standard laboratory tests after edoxaban ingestion
Primary Outcome Measure Information:
Title
correlation of edoxaban peak plasma concentrations and viscoelastic analysis
Description
viscoelastic test values and blood coagulation laboratory parameters
Time Frame
1 day
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy
Exclusion Criteria:
intolerance of the study drug history of bleeding disorder or similar
Facility Information:
Facility Name
Turku University Hospital
City
Turku
State/Province
Varsinais-Suomi
ZIP/Postal Code
20500
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
NOAC Plasma Concentration and Blood Coagulation in Healthy Volunteers
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