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

NCT04139525 | Unknown

• 1 other identifier: 0120-11/2019/3
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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®).

Conditions

End Stage Renal Disease; Haemodialysis; Anticoagulation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Clearance of urea

  At the end of each hemodialysis procedure.

• Clearance of creatinine

  At the end of each hemodialysis procedure.

• Clearance of p-cresol

  At the end of each hemodialysis procedure.

• White blood cell count

  At the start, after 15 minutes and at the end of each hemodialysis procedure.

• Blood platelet count

  At the start, after 15 minutes and at the end of each hemodialysis procedure.

Study Arms (1)

unfractionated heparin and 8% trisodium citrate

EXPERIMENTAL

Unfractionated heparin and 8% trisodium citrate.

Biological: unfractionated heparin; Biological: 8% trisodium citrate

Interventions

unfractionated heparin BIOLOGICAL

A bolus of 30 I.U./kg at the start of hemodialysis, followed by 18 I.U./kg per every hour of hemodialysis.

unfractionated heparin and 8% trisodium citrate

8% trisodium citrate BIOLOGICAL

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

unfractionated heparin and 8% trisodium citrate

Eligibility Criteria

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

You may qualify if:

• patient on chronic hemodialysis
• age 18 years old or more
• being able to give an informed consent to participate in the survey

You may not qualify if:

• on therapeutic anticoagulation
• citrate or heparin contraindicated
• citrate or heparin intolerance
• acute renal failure

Sponsors & Collaborators

• Marija Malgaj Vrečko: lead

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (1)

• 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.

  PMID: 36303108 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Heparin; trisodium citrate

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; 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

Study Officials

• Marija Malgaj Vrečko, MD

  University Medical Centre Ljubljana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The research will be performed as a prospective clinical trial. 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.

Study Record Dates

• First Submitted: October 12, 2019
• First Posted: October 25, 2019
• Study Start: September 15, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: June 7, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)