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

NCT ID: NCT04139525

Last Updated: 2022-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-15
• Study Completion Date: 2022-12-31

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.

Conditions

End Stage Renal Disease; Haemodialysis; Anticoagulation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

unfractionated heparin and 8% trisodium citrate

Unfractionated heparin and 8% trisodium citrate.

Group Type: EXPERIMENTAL

unfractionated heparin

Intervention Type: BIOLOGICAL

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

Intervention Type: BIOLOGICAL

8% trisodium citrate in the dose of 150 ml/h.

Interventions

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.

Intervention Type: BIOLOGICAL

8% trisodium citrate

8% trisodium citrate in the dose of 150 ml/h.

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marija Malgaj Vrečko

OTHER

Sponsor Role: lead

Responsible Party

Marija Malgaj Vrečko

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Marija Malgaj Vrečko, MD

Role: PRINCIPAL_INVESTIGATOR

University Medical Centre Ljubljana

Locations

University Medical Centre Ljubljana

Ljubljana, , Slovenia

Countries

Slovenia

References

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.

Reference Type: DERIVED

PMID: 36303108 (View on PubMed)

Other Identifiers

0120-11/2019/3

Identifier Type: -

Identifier Source: org_study_id