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

Acute Renal Insufficiency Clinical Trial

— VERROU HEMOST  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02860299
• Other study ID #: Bovet AOI 2015
• Status: Completed
• Phase: Phase 4
• First received: August 2, 2016
• Last updated: August 8, 2016
• Start date: February 2015

Study information

• Verified date: July 2016
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Insufficiency
• Renal Insufficiency

Intervention

Drug:
• citrate 4%

• unfractionated heparin

Biological:
• blood sample

Locations

Country	Name	City	State
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of calcaemia		through study completion an average of 28 days	No
Primary	Level of haemostasis		through study completion an average of 28 days	No