Biological and Clinical Measurements Following Systemic Leakage When a Citrate or Heparin Lock is Used (VERROU HEMOST)

University Hospital Center (CHU) Dijon Bourgogne

Status and phase

Completed

Phase 4

Conditions

Acute Renal Insufficiency

Treatments

Drug: unfractionated heparin

Biological: blood sample

Drug: citrate 4%

Study type

Interventional

Funder types

Other

Identifiers

NCT02860299

Bovet AOI 2015

Details and patient eligibility

About

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.

Enrollment

76 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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