Thrombosis and Haemorrhage in Chronic Hemodialysis Patients

Completed

• Conditions: Chronic Renal Failure

• Registration Number: NCT02897258
• Lead Sponsor: Central Hospital, Nancy, France

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.

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).

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Study First Submitted: 2016-08-30
• Status Verified: 2016-09
• Study First Submitted QC: 2016-09-07
• Last Update Submitted: 2016-09-07
• Study First Posted: 2016-09-13
• Last Update Posted: 2016-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Male or female aged 18 and over,
• In end-stage renal disease,
• Initiating a first hemodialysis replacement therapy in Lorraine between 01/01/2009 and 31/12/2010.

Exclusion Criteria

• Evolutionary Neoplasia at start of dialysis,
• Death within 45 days of the start of dialysis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival without major clinical event	up to 54 months	In Chronic Hemodialysis Patients