NCT02860299

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Centre Hospitalier Universitaire Dijon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Renal Insufficiency

Interventions

Type	Name	Description
DRUG	citrate 4%
DRUG	unfractionated heparin
BIOLOGICAL	blood sample

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-01-01
• First posted: 2016-08-09
• Last updated: 2026-03-12

Locations

1 site across 1 country: France