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

NCT02860299 | Completed Phase 4

• 1 other identifier: Bovet AOI 2015
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Renal Insufficiency

Keywords

patients

Outcome Measures

Primary Outcomes (2)

• Level of calcaemia

  through study completion an average of 28 days

• Level of haemostasis

  through study completion an average of 28 days

Study Arms (2)

Citrate lock

EXPERIMENTAL

Drug: citrate 4%; Biological: blood sample

Heparin lock

ACTIVE COMPARATOR

Drug: unfractionated heparin; Biological: blood sample

Interventions

citrate 4% DRUG

Citrate lock

unfractionated heparin DRUG

Heparin lock

blood sample BIOLOGICAL

Citrate lock; Heparin lock

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

Location

Related Publications (1)

• Bovet J, Soudry-Faure A, Merdji H, Ksiazek E, Quenot JP, Meziani F, Cransac A, Helms J. Evaluation of anti-Xa activity after injection of a heparin lock for dialysis catheters in intensive care: A prospective observational study. Thromb Res. 2020 Apr;188:82-84. doi: 10.1016/j.thromres.2020.02.006. Epub 2020 Feb 11. No abstract available.

  PMID: 32109772 RESULT

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Heparin; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: August 9, 2016
• Study Start: February 1, 2015
• Primary Completion: January 1, 2016
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

FR (1)