Clinical trial NCT04139525: Comparison of Citrate and Heparin Anticoagulation During Hemodialysis With MCO PES-PVP (Theranova) Membrane
Official title: Comparison of Citrate and Heparin Anticoagulation During Hemodialysis With Medium Cut-off Polyarylethersulphone- Polyvinylpirrolidone (Theranova) Membrane
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: End Stage Renal Disease
Haemodialysis
Anticoagulation
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare the efficiency and biocompatibility of citrate and heparin anticoagulation during hemodialysis with medium cut-off polyarylethersulphone-polyvinylpirrolidone membrane (Theranova®).

Detailed 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 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, β2-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.

Eligibility criteria: Inclusion Criteria:

* patient on chronic hemodialysis
* age 18 years old or more
* being able to give an informed consent to participate in the survey

Exclusion Criteria:

* on therapeutic anticoagulation
* citrate or heparin contraindicated
* citrate or heparin intolerance
* acute renal failure

Primary outcomes:
measure: Clearance of beta-2 microglobulin
timeFrame: At the end of each hemodialysis procedure.
measure: Clearance of phosphate
timeFrame: At the end of each hemodialysis procedure.
measure: Serum concentration of C3a, C5a, myeloperoxidase and PF-4
timeFrame: At the start, after 15 minutes and at the end of each hemodialysis procedure.
Secondary outcomes:
measure: Clearance of urea
timeFrame: At the end of each hemodialysis procedure.
measure: Clearance of creatinine
timeFrame: At the end of each hemodialysis procedure.
measure: Clearance of p-cresol
timeFrame: At the end of each hemodialysis procedure.
measure: White blood cell count
timeFrame: At the start, after 15 minutes and at the end of each hemodialysis procedure.
measure: Blood platelet count
timeFrame: At the start, after 15 minutes and at the end of each hemodialysis procedure.
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
Study officials:
affiliation: University Medical Centre Ljubljana
name: Marija Malgaj Vrečko, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vrecko MM, Pajek J, Buturovic-Ponikvar J. Use of regional citrate anticoagulation with medium cut-off membrane: pilot report. BMC Nephrol. 2022 Oct 27;23(1):346. doi: 10.1186/s12882-022-02960-y.