Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2026-03-06 @ 2:04 PM
Study NCT ID:
NCT02897258
Status:
COMPLETED
Last Update Posted:
2016-09-13
First Post:
2016-08-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thrombosis and Haemorrhage in Chronic Hemodialysis Patients
Sponsor:
Central Hospital, Nancy, France
Organization:
Study Overview
Official Title:
Thrombosis and Haemorrhage in Chronic Hemodialysis Patients - T2HD
Status:
COMPLETED
Status Verified Date:
2016-09
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:
T2HD
Brief Summary:
The study T2HD "Thrombosis and Haemorrhage in chronic hemodialysis patients" is a study of pharmacoepidemiology observational, retrospective cohort, multicenter including 12 dialysis centers for adults Lorraine.
The main objective is to :
Describe the prescribing practices of drugs anticoagulants and antiplatelet agents in chronic hemodialysis patients in the Lorraine region.
The second objective is to :
Study the impact of these practices on the survival and the occurrence of major clinical events, thrombotic and hemorrhagic.
The main objective is to :
Describe the prescribing practices of drugs anticoagulants and antiplatelet agents in chronic hemodialysis patients in the Lorraine region.
The second objective is to :
Study the impact of these practices on the survival and the occurrence of major clinical events, thrombotic and hemorrhagic.
Detailed Description:
All adult patients aged 18 and over who started a new hemodialysis replacement therapy in Lorraine between 01/01/2009 and 31/12/2010 are identified from the registry REIN (Epidemiology and Information Network in nephrology). The latter are included in the study T2HD to the initiation of dialysis and followed until the date point 30/06/2013.
The outcome was survival without major clinical event. Are considered major clinical events: acute coronary syndrome, acute limb ischemia, deep venous thrombosis, arterial thrombosis, pulmonary embolism, thrombosis First, ischemic or hemorrhagic stroke, the digestive hemorrhage, and severe bleeding.
Statistical analysis will compare event-free survival of patients in 4 groups. Patients will be censored at the time of the occurrence of a kidney transplant, a dialysis method of change, a dialysis withdrawal, a move outside Lorraine, or date point if they are still alive . To minimize bias maximum indication, patients of different groups will be matched on propensity score (probability for a given patient to be treated by antiplatelet and / or anticoagulant).
The outcome was survival without major clinical event. Are considered major clinical events: acute coronary syndrome, acute limb ischemia, deep venous thrombosis, arterial thrombosis, pulmonary embolism, thrombosis First, ischemic or hemorrhagic stroke, the digestive hemorrhage, and severe bleeding.
Statistical analysis will compare event-free survival of patients in 4 groups. Patients will be censored at the time of the occurrence of a kidney transplant, a dialysis method of change, a dialysis withdrawal, a move outside Lorraine, or date point if they are still alive . To minimize bias maximum indication, patients of different groups will be matched on propensity score (probability for a given patient to be treated by antiplatelet and / or anticoagulant).
Study Oversight
Has Oversight DMC:
False
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?: