Ignite Creation Date:
2024-05-06 @ 7:52 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02614573
Status:
COMPLETED
Last Update Posted:
2016-08-25
First Post:
2015-11-19
Brief Title:
International Normalised Ratio Evaluation by Generalist Practitioners in Full-time Care Establishments for the Elderly
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Organization:
Centre Hospitalier Universitaire de Nīmes
Study Overview
Official Title:
International Normalised Ratio Evaluation by Generalist Practitioners in Full-time Care Establishments for the Elderly a Pilot Study
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INR-Cap pilote
Brief Summary:
The main objective of this study is to evaluate for a 6-month observation period the concordance in terms of clinical decision making concerning therapeutic adjustment as determined by a weekly capillary International Normalised Ratio INR monitoring strategy versus the usual strategy in a population of dependent elderly people in nursing homes treated with anti-vitamin K AVK
Detailed Description:
The secondary objectives of this study are to
A Estimate the intra-patient variability of capillary INR measures
B Estimate the time spent in the target INR TTR window of dependent elderly patients in nursing homes under AVK treatment and with a capillary INR monitoring strategy
C Estimate the number of venous thromboembolic events and bleeding events over the 6-month observation period
A Estimate the intra-patient variability of capillary INR measures
B Estimate the time spent in the target INR TTR window of dependent elderly patients in nursing homes under AVK treatment and with a capillary INR monitoring strategy
C Estimate the number of venous thromboembolic events and bleeding events over the 6-month observation period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-A01056-43 | OTHER | RCB number | None |