Chronic Renal FailureT2HDNCT02897258
Thrombosis and Haemorrhage in Chronic Hemodialysis Patients
An observational study of Chronic Renal Failure, run by Central Hospital, Nancy, France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Renal Failure
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- Evolutionary Neoplasia at start of dialysis,
- Death within 45 days of the start of dialysis.
About this study
Official title: 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.
Read the 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
- Keywords
- Dialysis, Thrombosis, Haemorrhage
- Medical subject headings
- Kidney Failure, Chronic, Thrombosis, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Without anticoagulant/antiplatelet | Not described | |
| Treated with antiplatelet only | Not described | |
| Treated with anticoagulant only | Not described | |
| With antiplatelet/anticoagulant | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival without major clinical event
In Chronic Hemodialysis Patients
Measured: up to 54 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startJan 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal FailureStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GUILLEMIN Francis, MD, Central Hospital, Nancy, France
- Investigators
- Nathalie THILLY, Principal investigator, n.thilly@chru-nancy.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897258
- Sponsor's protocol ID
- T2HD-01
- Acronym
- T2HD
- Status last verified
- Sep 2016
- First submitted
- 30 Aug 2016
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombosis and Haemorrhage in Chronic Hemodialysis Patients - T2HD
- ClinicalTrials.gov ID
- NCT02897258
- Acronym / sponsor ID
- T2HD / T2HD-01
- Conditions
- Chronic Renal Failure
- Keywords
- Dialysis, Thrombosis, Haemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 13 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Without anticoagulant/antiplatelet | – | – |
| Treated with antiplatelet only | – | – |
| Treated with anticoagulant only | – | – |
| With antiplatelet/anticoagulant | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Evolutionary Neoplasia at start of dialysis,
- Death within 45 days of the start of dialysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival without major clinical event
Time frame: up to 54 months
In Chronic Hemodialysis Patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie THILLY principal investigator
n.thilly@chru-nancy.fr
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Renal Failure, run by Central Hospital, Nancy, France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival without major clinical event (time frame: up to 54 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2016.