Status:
COMPLETED
Strategies for Asymmetrical Triacetate Dialyzer Heparin-Free Effective Hemodialysis
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
NIPRO
Conditions:
Hemodialysis Complication
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Not all dialysis patients tolerate heparin anticoagulation. Heparin should be avoided in patients at high risk of bleeding. Strategies include saline infusion, citrate-containing dialysate, regional c...
Detailed Description
Anticoagulation is one of the supporting pillars of chronic hemodialysis (HD). The optimal anticoagulant regimen provides full anticoagulation of the extracorporeal circuit with minimal systemic effec...
Eligibility Criteria
Inclusion
- Patients age 18 years, or over. No maximum age is defined.
- Providing signed and dated informed consent (ICF)
- Maintenance dialysis (\> 3 months of hemodialysis)
- 'Standard' dialysis regimen (three dialysis sessions / week, dialysis duration 4 hours)
- Hemodynamic stability during 4 weeks preceding study period. Hemodynamic instability is defined as any episode of low blood pressure (asymptomatic or symptomatic requiring intervention (bolus fluid infusion, temporarily withholding or reducing ultrafiltration, preterm termination of dialysis session, resuscitation)
- Hemoglobin 9 - 12 g/dl.
Exclusion
- Any known medical disorder favoring either bleeding or clotting (e.g. atypical hemolytic uremic syndrome (aHUS), antiphospholipid syndrome, idiopathic thrombocytopenic purpura (ITP), paroxysmal nocturnal hemoglobinuria (PNH))
- Treatment with a vitamin K antagonist
- Treatment with any one of the NOACs (apixaban, rivaroxaban, edoxaban, dabigatran)
- High risk of bleeding according to the criteria of Swartz (12).
- Patients with a known allergic reaction to asymmetric triacetate
- Pregnancy
Key Trial Info
Start Date :
January 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04381234
Start Date
January 6 2018
End Date
May 5 2020
Last Update
May 21 2020
Active Locations (1)
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1
University Hospitals Leuven
Leuven, Vlaams-Brabant, Belgium, 3000