NCT02897258

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
Last Updated

September 13, 2016

Status Verified

September 1, 2016

Enrollment Period

2.4 years

First QC Date

August 30, 2016

Last Update Submit

September 7, 2016

Conditions

Chronic Renal Failure

Keywords

DialysisThrombosisHaemorrhage

Outcome Measures

Primary Outcomes (1)

  • Survival without major clinical event

    In Chronic Hemodialysis Patients

    up to 54 months

Study Arms (4)

Without anticoagulant/antiplatelet

Treated with antiplatelet only

Treated with anticoagulant only

With antiplatelet/anticoagulant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kidney Failure, ChronicThrombosisHemorrhage

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Nathalie THILLY

    n.thilly@chru-nancy.fr

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 30, 2016

First Posted

September 13, 2016

Study Start

January 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

September 13, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share