Acute Renal InsufficiencyPhase 4VERROU HEMOSTNCT02860299
Biological and Clinical Measurements Following Systemic Leakage When a Citrate or Heparin Lock is Used
A Phase 4 study testing citrate 4%, unfractionated heparin and blood sample in people with Acute Renal Insufficiency, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
In the VERROUREA study, there were two cases of an abnormal increase in TCA. In theory no leakage of the lock into the bloodstream should have been seen. Lock leakage could have particularly serious, and especially clinical, repercussions in these patients who already have a high risk of haemorrhage given the numerous… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Renal Insufficiency
- What is being tested?
- citrate 4%, unfractionated heparin and blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to Jan 2016
- Phase
- Phase 4
- 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
Who may be able to join
- Patient aged > 18 years
- Requiring dialysis for acute kidney failure
- In whom a first non-tunnelled catheter has been inserted
- In the jugular or femoral position
- Once informed consent has been obtained from the patient, a family member or a person of trust
Who cannot join
- Patients with active and poorly-controlled bleeding
- Known allergy to citrate
- Liver failure (Factor V <30%)
- Thrombopenia < 30 000/mm3 in the absence of planned corrective measures at the time of randomization
- Known or suspected heparin-induced thrombopenia
- Positive blood cultures without treatment or with inappropriate treatment at the time of randomization
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- Catheter inserted in the subclavian position
- Person without national health insurance cover
- Pregnant women
- Adults under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Systemic Leakage When a Heparin or Citrate Lock is Injected and Biological and Clinical Repercussions: Ancillary Study of the VERROU-REA Randomized Controlled Trial
In the VERROUREA study, there were two cases of an abnormal increase in TCA. In theory no leakage of the lock into the bloodstream should have been seen. Lock leakage could have particularly serious, and especially clinical, repercussions in these patients who already have a high risk of haemorrhage given the numerous associated comorbidities. The aim of this study is to investigate the leakage of locks into the bloodstream by measuring, before and after injection of the lock, the evolution of haemostasis tests and calcaemia. The findings will complete safety data already collected in the VERROU REA study.
- Conditions
- Acute Renal Insufficiency
- Being tested
- citrate 4%, unfractionated heparin, blood sample
- Keywords
- patients
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
citrate 4%Drug
unfractionated heparinDrug
blood sampleBiological
| Study group | Role | What they receive |
|---|---|---|
| Citrate lock | Experimental | Not described Receives: Drug: citrate 4%; Biological: blood sample |
| Heparin lock | Active comparator | Not described Receives: Drug: unfractionated heparin; Biological: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of calcaemia
Measured: through study completion an average of 28 days
Level of haemostasis
Measured: through study completion an average of 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startFeb 2015
- Primary completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Renal InsufficiencyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02860299
- Sponsor's protocol ID
- Bovet AOI 2015
- Acronym
- VERROU HEMOST
- Status last verified
- Mar 2026
- First submitted
- 2 Aug 2016
- Last updated
- 12 Mar 2026
- Results posted
- No
Publications
Bovet J, Soudry-Faure A, Merdji H, Ksiazek E, Quenot JP, Meziani F, Cransac A, Helms J. Evaluation of anti-Xa activity after injection of a heparin lock for dialysis catheters in intensive care: A prospective observational study. Thromb Res. 2020 Apr;188:82-84. doi: 10.1016/j.thromres.2020.02.006. Epub 2020 Feb 11. No abstract available.
PubMed 32109772
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Systemic Leakage When a Heparin or Citrate Lock is Injected and Biological and Clinical Repercussions: Ancillary Study of the VERROU-REA Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02860299
- Acronym / sponsor ID
- VERROU HEMOST / Bovet AOI 2015
- Conditions
- Acute Renal Insufficiency
- Keywords
- patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jan 2016 (actual)
- First posted
- 9 Aug 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.
In the VERROUREA study, there were two cases of an abnormal increase in TCA. In theory no leakage of the lock into the bloodstream should have been seen. Lock leakage could have particularly serious, and especially clinical, repercussions in these patients who already have a high risk of haemorrhage given the numerous associated comorbidities. The aim of this study is to investigate the leakage of locks into the bloodstream by measuring, before and after injection of the lock, the evolution of haemostasis tests and calcaemia. The findings will complete safety data already collected in the VERROU REA study.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Citrate lock | Experimental | Drug: citrate 4%, Biological: blood sample |
| Heparin lock | Active comparator | Drug: unfractionated heparin, Biological: blood sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient aged > 18 years
- Requiring dialysis for acute kidney failure
- In whom a first non-tunnelled catheter has been inserted
- In the jugular or femoral position
- Once informed consent has been obtained from the patient, a family member or a person of trust
Key exclusion criteria (10 listed)
- Patients with active and poorly-controlled bleeding
- Known allergy to citrate
- Liver failure (Factor V <30%)
- Thrombopenia < 30 000/mm3 in the absence of planned corrective measures at the time of randomization
- Known or suspected heparin-induced thrombopenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| citrate 4% | Drug | Citrate lock |
| unfractionated heparin | Drug | Heparin lock |
| blood sample | Biological | Citrate lock, Heparin lock |
Primary outcome
Level of calcaemia
Time frame: through study completion an average of 28 days
Level of haemostasis
Time frame: through study completion an average of 28 days
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 12 Mar 2026.
- Results publication: PubMed 32109772Bovet J, Soudry-Faure A, Merdji H, Ksiazek E, Quenot JP, Meziani F, Cransac A, Helms J. Evaluation of anti-Xa activity after injection of a heparin lock for dialysis catheters in intensive care: A prospective observational study. Thromb Res. 2020 Apr;188:82-84. doi: 10.1016/j.thromres.2020.02.006. Epub 2020 Feb 11. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing citrate 4%, unfractionated heparin and blood sample in people with Acute Renal Insufficiency, run by Centre Hospitalier Universitaire Dijon at 1 site in 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 5 inclusion and 10 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 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Level of calcaemia (time frame: through study completion an average of 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02860299, which also lists 1 linked publication.
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 12 Mar 2026.