Strategies for Asymmetrical Triacetate Dialyzer Heparin-Free Effective Hemodialysis

NCT04381234 | Completed Phase 2

• 1 other identifier: S61285
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Not all dialysis patients tolerate heparin anticoagulation. Heparin should be avoided in patients at high risk of bleeding. Strategies include saline infusion, citrate-containing dialysate, regional citrate anticoagulation and heparin-coated membranes. We recently studied the combination of a heparin-coated membrane and citrate-containing dialysate, with a success rate of 94% . Although this combination resulted in low rates of clotting, heparin-coated membranes are not ubiquitously available. The quest for easy to perform, safe and affordable heparin-free dialysis is on. Asymmetric cellulose triacetate (ATA) dialyzers have a low degree of platelet contact activation and might be an alternative to heparin-coated dialyzers. This is a phase II pilot study in maintenance dialysis patients. Study design is a two-arm open-label cross-over study. In Arm 1, patients were dialyzed using a 1.9 m2 ATA membrane (Solacea™-19H, Nipro Corp., Japan) in combination with citrate (1 mM) containing dialysate. In Arm 2, patients were dialyzed with the same 1.9 m2 ATA membrane, in combination with high volume predilution hemodiafiltration. The primary endpoint was the success rate to complete 4 hours of hemodialysis without preterm clotting.

Conditions

Hemodialysis Complication

Keywords

anticoagulation; clotting; hemodialysis; hemodiafiltration; citrate

Outcome Measures

Primary Outcomes (1)

• clinical patency of the hemodialysis extracorporeal circuit

  clotting of the extracorporeal circuit

  4 hours

Secondary Outcomes (3)

• Clotting of dialyser

  4 hours

• dialysis adequacy

  4hours

• Reduction ratio uremic retention solutes

  4 hours

Study Arms (2)

ATA plus citrate

EXPERIMENTAL

1.9 m2 ATA membrane (Solacea™-19H, Nipro Corp., Japan) in combination with citrate (1 mM) containing dialysate

Device: dialyzer; Combination Product: hemodialysis with citrate-containing dialysate

ATA plus predilution hemodiafiltration

ACTIVE COMPARATOR

1.9 m2 ATA membrane (Solacea™-19H, Nipro Corp., Japan), in combination with high volume predilution hemodiafiltration

Device: dialyzer; Other: predilution hemodiafiltration

Interventions

dialyzer DEVICE

Asymmetric triacetate dialyzer

Also known as: Solacea™-19H (Nipro Corp., Japan)

ATA plus citrate; ATA plus predilution hemodiafiltration

hemodialysis with citrate-containing dialysate COMBINATION_PRODUCT

acetate-free dialysate

Also known as: Selectbag citrate (1mM citrate, Baxter)

ATA plus citrate

predilution hemodiafiltration OTHER

predilution hemodiafiltration

ATA plus predilution hemodiafiltration

Eligibility Criteria

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

You may qualify if:

• Patients age 18 years, or over. No maximum age is defined.
• Providing signed and dated informed consent (ICF)
• Maintenance dialysis (\> 3 months of hemodialysis)
• 'Standard' dialysis regimen (three dialysis sessions / week, dialysis duration 4 hours)
• Hemodynamic stability during 4 weeks preceding study period. Hemodynamic instability is defined as any episode of low blood pressure (asymptomatic or symptomatic requiring intervention (bolus fluid infusion, temporarily withholding or reducing ultrafiltration, preterm termination of dialysis session, resuscitation)
• Hemoglobin 9 - 12 g/dl.

You may not qualify if:

• Any known medical disorder favoring either bleeding or clotting (e.g. atypical hemolytic uremic syndrome (aHUS), antiphospholipid syndrome, idiopathic thrombocytopenic purpura (ITP), paroxysmal nocturnal hemoglobinuria (PNH))
• Treatment with a vitamin K antagonist
• Treatment with any one of the NOACs (apixaban, rivaroxaban, edoxaban, dabigatran)
• High risk of bleeding according to the criteria of Swartz (12).
• Patients with a known allergic reaction to asymmetric triacetate
• Pregnancy

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• NIPRO: collaborator

Study Sites (1)

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Publications (1)

• Natale P, Palmer SC, Ruospo M, Longmuir H, Dodds B, Prasad R, Batt TJ, Jose MD, Strippoli GF. Anticoagulation for people receiving long-term haemodialysis. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD011858. doi: 10.1002/14651858.CD011858.pub2.

  PMID: 38189593 DERIVED

MeSH Terms

Conditions

Thrombosis

Interventions

Kidneys, Artificial; Renal Dialysis; Citric Acid

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Artificial Organs; Surgical Equipment; Equipment and Supplies; Renal Replacement Therapy; Therapeutics; Sorption Detoxification; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• bjorn D Meijers, MD, PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: open-label sequential cross-over study

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 8, 2020
• Study Start: January 6, 2018
• Primary Completion: March 10, 2019
• Study Completion: May 5, 2020
• Last Updated: May 21, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)