Biological and Clinical Measurements Following Systemic Leakage When a Citrate or Heparin Lock is… (NCT02860299) | Clinical Trial Compass
CompletedPhase 4
Biological and Clinical Measurements Following Systemic Leakage When a Citrate or Heparin Lock is Used
France76 participantsStarted 2015-02
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* Catheter inserted in the subclavian position
* Person without national health insurance cover
* Pregnant women
* Adults under guardianship
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Level of calcaemia
Timeframe: through study completion an average of 28 days
2
Level of haemostasis
Timeframe: through study completion an average of 28 days