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Biological and Clinical Measurements Following Systemic Leakage When a Citrate or Heparin Lock is Used

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02860299
Acronym
VERROU HEMOST
Enrollment
76
Registered
2016-08-09
Start date
2015-02-01
Completion date
Unknown
Last updated
2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Renal Insufficiency

Keywords

patients

Brief 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.

Interventions

DRUGunfractionated heparin
BIOLOGICALblood sample

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Level of calcaemiathrough study completion an average of 28 days
Level of haemostasisthrough study completion an average of 28 days

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026