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

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

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®).

Study Overview

• Status: Active, not recruiting
• Conditions: End Stage Renal Disease; Anticoagulation; Haemodialysis
• Intervention / Treatment: Biological: unfractionated heparin; Biological: 8% trisodium citrate

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • University Medical Centre Ljubljana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: unfractionated heparin and 8% trisodium citrate; Unfractionated heparin and 8% trisodium citrate.	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.; Biological: 8% trisodium citrate; 8% trisodium citrate in the dose of 150 ml/h.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clearance of beta-2 microglobulin	Overall and instantaneous clearance of beta-2 microglobulin.	At the end of each hemodialysis procedure.
Clearance of phosphate	Overall and instantaneous clearance of phosphate.	At the end of each hemodialysis procedure.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clearance of urea	Overall and instantaneous clearance of urea.	At the end of each hemodialysis procedure.
Clearance of creatinine	Overall and instantaneous clearance of creatinine.	At the end of each hemodialysis procedure.
Clearance of p-cresol	Overall and instantaneous clearance of p-cresol.	At the end of each hemodialysis procedure.
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.
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.

Collaborators and Investigators

• Sponsor: Marija Malgaj Vrečko
• Investigators: Principal Investigator: Marija Malgaj Vrečko, MD, University Medical Centre Ljubljana

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: October 12, 2019
• First Submitted That Met QC Criteria: October 24, 2019
• First Posted (Actual): October 25, 2019

Study Record Updates

• Last Update Posted (Actual): June 7, 2022
• Last Update Submitted That Met QC Criteria: June 4, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Chelating Agents; Sequestering Agents; Calcium Chelating Agents; Heparin; Calcium heparin; Citric Acid; Sodium Citrate
• Other Study ID Numbers: 0120-11/2019/3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No