Comparison of Citrate and Heparin Anticoagulation During Hemodialysis With MCO PES-PVP (Theranova) Membrane

Not Applicable

• Conditions: Anticoagulation; Haemodialysis; End Stage Renal Disease

• Registration Number: NCT04139525
• Lead Sponsor: Marija Malgaj Vrečko

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.

Study Timeline

• Study First Submitted: 2019-10-12
• Study First Submitted QC: 2019-10-24
• Study First Posted: 2019-10-25
• Study Start: 2020-09-15
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-04
• Last Update Posted: 2022-06-07
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Clearance of phosphate	At the end of each hemodialysis procedure.	Overall and instantaneous clearance of phosphate.
Clearance of beta-2 microglobulin	At the end of each hemodialysis procedure.	Overall and instantaneous clearance of beta-2 microglobulin.
Serum concentration of C3a, C5a, myeloperoxidase and PF-4	At the start, after 15 minutes and at the end of each hemodialysis procedure.	Blood for the laboratory measurements will be taken from the arterial line.

Secondary Outcome Measures

Name	Time	Method
White blood cell count	At the start, after 15 minutes and at the end of each hemodialysis procedure.	Blood for the laboratory measurements will be taken from the arterial line.
Clearance of p-cresol	At the end of each hemodialysis procedure.	Overall and instantaneous clearance of p-cresol.
Clearance of urea	At the end of each hemodialysis procedure.	Overall and instantaneous clearance of urea.
Clearance of creatinine	At the end of each hemodialysis procedure.	Overall and instantaneous clearance of creatinine.
Blood platelet count	At the start, after 15 minutes and at the end of each hemodialysis procedure.	Blood for the laboratory measurements will be taken from the arterial line.

Trial Locations

Locations (1)

University Medical Centre Ljubljana; 🇸🇮 Ljubljana, Slovenia