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

Marija Malgaj Vrečko

Status: Active, not recruiting

Conditions: Anticoagulation; Haemodialysis; End Stage Renal Disease

Treatments: Biological: unfractionated heparin; Biological: 8% trisodium citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT04139525

0120-11/2019/3

Details and patient eligibility

About

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®).

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

unfractionated heparin and 8% trisodium citrate

Experimental group

Description:

Unfractionated heparin and 8% trisodium citrate.

Treatment:

Biological: 8% trisodium citrate

Biological: unfractionated heparin