Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Anticoagulation
  • End Stage Renal Disease
  • Haemodialysis
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: The research will be performed as a prospective clinical trial. Every patient will have 2 HD procedures with PES-PVP membrane in a randomized order: 1 with unfractionated heparin (UFH) and 1 with 8% trisodium citrate.Masking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

The purpose of the study is to compare the efficiency and biocompatibility of citrate and heparin anticoagulation during hemodialysis (HD) with PES-PVP membrane. The research will be performed as a prospective clinical trial and will include 35 patients. Every patient will have 2 HD procedures with ...

The purpose of the study is to compare the efficiency and biocompatibility of citrate and heparin anticoagulation during hemodialysis (HD) with PES-PVP membrane. The research will be performed as a prospective clinical trial and will include 35 patients. Every patient will have 2 HD procedures with PES-PVP membrane in a randomized order: 1 with unfractionated heparin (UFH) and 1 with 8% trisodium citrate. We will compare the efficiency of both types of anticoagulation by measuring overall and instantaneous clearances of small, middle and protein-bound molecules (urea, creatinine, phosphate, ?2-microglobulin, p-cresol). Biocompatibility will be evaluated by measuring activation of: complement (serum concentration of C3a and C5a), leukocytes (serum concentration of myeloperoxidase) and thrombocytes (serum concentration of PF4). We will also monitor complete blood count for occurrence of leukopenia and thrombocytopenia. After the HD electron microscopy of the membrane will be done in the proportion of included patients to evaluate adsorption of cells and formation of blood clots on the membrane.

Tracking Information

NCT #
NCT04139525
Collaborators
Not Provided
Investigators
Principal Investigator: Marija Malgaj Vre?ko, MD University Medical Centre Ljubljana