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NCT02902848 Clinical Trial

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

Haemodialysis Clinical Trial

— COAGHEMO  

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02902848
Other study ID # COAGHEMO
Secondary ID
Status Recruiting
Phase N/A
First received September 8, 2016
Last updated September 13, 2016
Start date March 2015

Study information
Verified date September 2016
Source University Hospital, Brest
Contact Yannick Le meur, MD-PhD
Email yannick.lemeur@chu-brest.fr
Is FDA regulated No
Health authority France: Institutional Ethical Committee
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age > 18

- Haemodialyzed patient whose INR needs to be monitored

- Patient not objecting to participate in the study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
France CHU Brest Brest

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary correlation ratio between point-of-care PT/INR value and standard laboratory assessement 5 months No
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