Status:
COMPLETED
Regional Anticoagulation of Dialysis Circuits With a Calcium-free Citrate-containing Dialysate
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Hemodialysis Complication
Bleeding
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Critically ill patients have a high risk of bleeding but also require prolonged intermittent dialysis. Thus, a heparin-free easy-to-use alternative type of anticoagulation within the dialysis circuit ...
Detailed Description
Critically ill patients have a high risk of bleeding but also require prolonged intermittent dialysis. Several modalities are used for heparin-free dialysis sessions. Iterative saline infusion and hep...
Eligibility Criteria
Inclusion
- will be included in the study, patients
- hat require two sessions of dialysis that last for greater than 240 minutes in the 7 days following the inclusion.
- With a moderate to high risk of bleeding (platelets count below 150.000/mm3; platelet disorders; bleeding in the last 10 days, surgery or biopsy in the last 10 days or planned in the next 7 days; admission to the ICU)
- Older than 18 years of age
- That gave written informed consent
Exclusion
- will be excluded from the study, patients with
- Heparin allergy
- On-going treatment by vitamin-K antagonists (INR \> 1.2) or unfractionated heparin (anti-Xa activity \> 0.10)..
- Known allergy to the Evodial (Baxter, France) or Cordiax FX100 (Fresenius, France) membranes
- On-going treatment by angiotensin converting enzyme inhibitors
- Pregnancy or risk of pregnancy
- Patient under guardianship
Key Trial Info
Start Date :
July 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 13 2021
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT03842657
Start Date
July 5 2019
End Date
September 13 2021
Last Update
December 15 2025
Active Locations (5)
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1
Pellegrin Hospital
Bordeaux, France
2
Montpellier Hospital
Montpellier, France
3
Nimes Hospital
Nîmes, France
4
Tenon Hospital
Paris, France