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Completed

NCT Number: NCT02860299

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

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.

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Key information

Conditions

Acute Renal Insufficiency Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU Dijon Bourgogne

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

citrate 4%

Drug

Unfractionated heparin

Drug

Blood sample

Biological

Primary outcomes

  1. Level of calcaemia

    Time frame: through study completion an average of 28 days

  2. Level of haemostasis

    Time frame: through study completion an average of 28 days

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study 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

Acronym: VERROU HEMOST

Important dates

Study start
2015
Primary completion
2016
First posted
Aug 9, 2016
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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