COAGHEMO: Evaluation of the Validity of the Prothrombin Time Internation Normalised Ratio (PT/INR) Measured at the point-of Care on the Arterial Bloodline of Haemodialysis Extracorporeal Blood Flow
Sponsor
University Hospital, Brest (Other)
Overall Status
Unknown status
CT.gov ID
NCT02902848
Collaborator
(none)
30
1
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the INR value of hemodialyzed patient coagulation state (prothrombin time) measured inside the therapeutical zone and thanks to a portable monitor. The values obtained at the point of care will be compared to the standard biological assessment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Study Start Date
:
Mar 1, 2015
Anticipated Primary Completion Date
:
Mar 1, 2017
Outcome Measures
Primary Outcome Measures
- correlation ratio between point-of-care PT/INR value and standard laboratory assessement [5 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Age > 18
-
Haemodialyzed patient whose INR needs to be monitored
-
Patient not objecting to participate in the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU Brest | Brest | France | 29200 |
Sponsors and Collaborators
- University Hospital, Brest
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT02902848
Other Study ID Numbers:
- COAGHEMO
First Posted:
Sep 16, 2016
Last Update Posted:
Sep 16, 2016
Last Verified:
Sep 1, 2016