Thrombosis and Haemorrhage in Chronic Hemodialysis Patients

NCT ID: NCT02897258

Last Updated: 2016-09-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-06-30

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).

Conditions

Chronic Renal Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Without anticoagulant/antiplatelet

No interventions assigned to this group

Treated with antiplatelet only

No interventions assigned to this group

Treated with anticoagulant only

No interventions assigned to this group

With antiplatelet/anticoagulant

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

GUILLEMIN Francis, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nathalie THILLY

Role: PRINCIPAL_INVESTIGATOR

n.thilly@chru-nancy.fr

Other Identifiers

T2HD-01

Identifier Type: -

Identifier Source: org_study_id