Thrombosis and Haemorrhage in Chronic Hemodialysis Patients (T2HD)

Thrombosis and Haemorrhage in Chronic Hemodialysis Patients - T2HD

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.

Study Overview

• Status: Completed
• Conditions: Chronic Renal Failure

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 Type: Observational
• Enrollment (Actual): 600

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients treated for end-stage renal disease by chronic hemodialysis, in one of the 12 dialysis centers for adult Lorraine region (heavy or dialysis centers medicalized units).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Without anticoagulant/antiplatelet
Treated with antiplatelet only
Treated with anticoagulant only
With antiplatelet/anticoagulant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival without major clinical event	In Chronic Hemodialysis Patients	up to 54 months

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Nathalie THILLY, n.thilly@chru-nancy.fr

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (ACTUAL): June 1, 2015
• Study Completion (ACTUAL): June 1, 2015

Study Registration Dates

• First Submitted: August 30, 2016
• First Submitted That Met QC Criteria: September 7, 2016
• First Posted (ESTIMATE): September 13, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): September 13, 2016
• Last Update Submitted That Met QC Criteria: September 7, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Thrombosis; Dialysis; Haemorrhage
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Embolism and Thrombosis; Renal Insufficiency, Chronic; Hemorrhage; Kidney Failure, Chronic; Thrombosis
• Other Study ID Numbers: T2HD-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO