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

End Stage Renal Disease Clinical Trial

Official title:

Comparison of Citrate and Heparin Anticoagulation During Hemodialysis With Medium Cut-off Polyarylethersulphone- Polyvinylpirrolidone (Theranova) Membrane

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04139525
• Other study ID #: 0120-11/2019/3
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 15, 2020
• Est. completion date: December 2022

Study information

• Verified date: June 2022
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anticoagulation
• End Stage Renal Disease
• Haemodialysis
• Kidney Failure, Chronic

Intervention

Biological:
• unfractionated heparin
A bolus of 30 I.U./kg at the start of hemodialysis, followed by 18 I.U./kg per every hour of hemodialysis.
• 8% trisodium citrate
8% trisodium citrate in the dose of 150 ml/h.

Locations

Country	Name	City	State
Slovenia	University Medical Centre Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
Marija Malgaj Vrecko

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clearance of beta-2 microglobulin	Overall and instantaneous clearance of beta-2 microglobulin.	At the end of each hemodialysis procedure.
Primary	Clearance of phosphate	Overall and instantaneous clearance of phosphate.	At the end of each hemodialysis procedure.
Primary	Serum concentration of C3a, C5a, myeloperoxidase and PF-4	Blood for the laboratory measurements will be taken from the arterial line.	At the start, after 15 minutes and at the end of each hemodialysis procedure.
Secondary	Clearance of urea	Overall and instantaneous clearance of urea.	At the end of each hemodialysis procedure.
Secondary	Clearance of creatinine	Overall and instantaneous clearance of creatinine.	At the end of each hemodialysis procedure.
Secondary	Clearance of p-cresol	Overall and instantaneous clearance of p-cresol.	At the end of each hemodialysis procedure.
Secondary	White blood cell count	Blood for the laboratory measurements will be taken from the arterial line.	At the start, after 15 minutes and at the end of each hemodialysis procedure.
Secondary	Blood platelet count	Blood for the laboratory measurements will be taken from the arterial line.	At the start, after 15 minutes and at the end of each hemodialysis procedure.