Comparison of Citrate and Heparin Anticoagulation During Postdilution Hemodiafiltration

NCT07618858 | Not Yet Recruiting

• 2 other identifiers: BIOCOMP-HDF0120-610/2025-2711-5
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized crossover clinical trial will compare regional citrate anticoagulation (RCA) and standard heparin anticoagulation (HA) during postdilution hemodiafiltration (HDF) in chronic dialysis patients with end-stage kidney disease. The primary aim of the study is to evaluate biocompatibility during HDF by measuring markers of complement activation (C3a), platelet activation (PF4), and coagulation activation (thrombin-antithrombin complex, TAT). Secondary aims include comparison of solute removal efficiency, including beta-2 microglobulin, phosphate, and urea removal, as well as assessment of citrate, calcium, and magnesium kinetics during citrate anticoagulation. Twenty adult chronic dialysis patients will undergo two study HDF procedures in randomized order: one procedure using heparin anticoagulation and one procedure using regional citrate anticoagulation with a one-week interval between procedures. The study aims to improve understanding of the effects of anticoagulation methods on hemodiafiltration biocompatibility and dialysis efficiency and may contribute to optimization of citrate anticoagulation protocols in chronic hemodiafiltration patients.

Conditions

End-Stage Kidney Disease; Hemodiafiltration; Chronic Hemodialysis; Renal Failure

Keywords

Citrate anticoagulation; Heparin anticoagulation; Hemodiafiltration; Dialysis; Biocompatibility; Beta-2 microglobulin; Complement activation; Regional citrate anticoagulation; Chronic dialysis; Thrombin-antithrombin complex; Platelet factor 4

Outcome Measures

Primary Outcomes (1)

• Biocompatibility markers (C3a, PF4, TAT)

  Comparison of complement activation marker C3a, platelet factor 4 (PF4), and thrombin-antithrombin complex (TAT) concentrations between citrate and heparin anticoagulation during postdilution hemodiafiltration.

  Before hemodiafiltration, after 15 minutes of treatment, and immediately before the end of the procedure.

Secondary Outcomes (5)

• Beta-2 microglobulin removal

  Before, after 30 minutes and at the end of the procedure hemodiafiltration procedure.

• instantaneous urea clearance after 30 minutes

  after 30 minutes of dialysis

• p-cresyl sulfat removal

  P-cresyl sulfat removal before, during and to the end of procedure

• Ionized calcium kinetics

  During the 4-hour hemodiafiltration procedure

• Extracorporeal circuit clotting score

  At the end of hemodiafiltration procedure.

Study Arms (2)

Citrate anticoagulation

EXPERIMENTAL

Participants will undergo postdilution hemodiafiltration using regional citrate anticoagulation with 8% trisodium citrate infusion and calcium substitution according to ionized calcium measurements

Drug: Regional citrate anticoagulation

Heparin anticoagulation

ACTIVE COMPARATOR

Participants will undergo postdilution hemodiafiltration using standard unfractionated heparin anticoagulation according to routine clinical protocol.

Drug: Unfractionated heparin

Interventions

Regional citrate anticoagulation DRUG

Regional citrate anticoagulation using 8% trisodium citrate infusion during postdilution hemodiafiltration with calcium substitution adjusted according to ionized calcium levels.

Citrate anticoagulation

Unfractionated heparin DRUG

Standard unfractionated heparin anticoagulation administered according to routine clinical protocol during postdilution hemodiafiltration.

Heparin anticoagulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older
• End-stage kidney disease requiring maintenance postdilution hemodiafiltration
• Stable chronic hemodialysis treatment three times weekly
• Functional arteriovenous fistula

You may not qualify if:

• Therapeutic anticoagulation therapy
• Dual antiplatelet therapy
• Significant coagulopathy
• Active bleeding
• Acute kidney injury

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency

Interventions

Heparin

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Central Study Contacts

Milena MD Andonova

CONTACT

+38615228123; milena.andonova@kclj.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of Nephrology

Model Details: Participants will undergo two study hemodiafiltration procedures in randomized order: one procedure using heparin anticoagulation and one procedure using regional citrate anticoagulation, with a one-week interval between procedures.

Study Record Dates

• First Submitted: May 16, 2026
• First Posted: June 1, 2026
• Study Start: June 5, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)