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Completed

NCT Number: NCT02897258

Thrombosis and Haemorrhage in Chronic Hemodialysis Patients

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Survival without major clinical event

    Time frame: up to 54 months

    In Chronic Hemodialysis Patients

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Thrombosis and Haemorrhage in Chronic Hemodialysis Patients - T2HD

Acronym: T2HD

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 13, 2016
Registry last updated
Sep 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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