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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02860299
Recruitment Status : Completed
First Posted : August 9, 2016
Last Update Posted : August 9, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

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.

Condition or disease Intervention/treatment Phase
Acute Renal Insufficiency Drug: citrate 4% Drug: unfractionated heparin Biological: blood sample Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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
Study Start Date : February 2015
Actual Primary Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Experimental: Citrate lock Drug: citrate 4%
Biological: blood sample
Active Comparator: Heparin lock Drug: unfractionated heparin
Biological: blood sample



Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860299


Locations
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France
CHU Dijon Bourgogne
Dijon, France, 21079
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02860299    
Other Study ID Numbers: Bovet AOI 2015
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: July 2016
Keywords provided by Centre Hospitalier Universitaire Dijon:
patients
Additional relevant MeSH terms:
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Renal Insufficiency
Acute Kidney Injury
Kidney Diseases
Urologic Diseases
Heparin
Calcium heparin
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents