Variability in Micro-CT Imaging Results to Quantify Dialyzer Clotting

NCT06140563 | Completed

• 1 other identifier: ONZ-2023-0201
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Different cross-over studies have been performed investigating dialyzer fiber patency in different dialysis setups. Herewith, post dialysis micro computed tomography (CT) images of the dialyzer were compared. For the best interpretation of such results, one should have an idea about the intrapatient variability. There is also no clue about the impact of long distance transportation and long cold storage on the reproducibility of the micro CT images. Another bottle neck is that, up till now, no biochemical parameter or test has been found associated with the outcome of dialyzer fiber patency post dialysis. The present study therefore aims at determining the intrapatient variability and the impact on the micro CT results of long distance transportation and long cold storage of the dialyzers. Also, whole blood thrombin generation tests are performed to look for associations with the micro CT results.

Conditions

Hemodialysis Complication; Anticoagulants

Keywords

dialyzer fiber clotting

Outcome Measures

Primary Outcomes (1)

• Intrapatient variability of dialyzer fiber patency

  The intrapatient variability of the dialyzer fiber patency (i.e. percentage open fibers post dialysis) and the intraclass correlation coefficient (ICC) of fiber patency are calculated from the results of the post dialysis micro CT images of the dialyzer, as scanned after three consecutive dialysis sessions with the same anticoagulation dosing: one week with full anticoagulation and one week with reduced (1/4) anticoagulation. Outcome = intrapatient variability of the percentage open fibers. Tool = micro CT scanning and computer-based determination of fiber patency.

  2 months

Secondary Outcomes (3)

• Impact of dialyzer storage and transport on micro CT images of dialyzer fibers

  3 months

• Association between whole blood thrombin generation test and fiber patency

  2 months

• Difference in fiber patency using normal versus reduced anticoagulation dosing.

  2 months

Study Arms (2)

Normal anticoagulation dosing

EXPERIMENTAL

Patients are dialyzed during three consecutive hemodialysis sessions with an FX800 Cordiax dialyzer, blood flow of 300mL/min, dialysate flow of 500mL/min and ultrafiltration according to the needs of the patient. At the start of the dialysis session, the normal amount of anticoagulation is administered.

Other: anticoagulation dosing

Reduced anticoagulation dosing

EXPERIMENTAL

Patients are dialyzed during three consecutive hemodialysis sessions with an FX800 Cordiax dialyzer, blood flow of 300mL/min, dialysate flow of 500mL/min and ultrafiltration according to the needs of the patient. At the start of the dialysis session, only one quarter of the normal amount of anticoagulation is administered.

Other: anticoagulation dosing

Interventions

anticoagulation dosing OTHER

In one arm the normal amount of anticoagulation is administered at the dialysis start, while this is only a quarter of the normal amount of anticoagulation in the other arm.

Normal anticoagulation dosing; Reduced anticoagulation dosing

Eligibility Criteria

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

You may qualify if:

• stable chronic hemodialysis patient
• well functioning vascular access

You may not qualify if:

• ultrafiltration rate higher than 4 litre per session
• use of antiplatelets or anticoagulants (apart from acetylsalicylic acid)
• known coagulation disorder
• active inflammation
• malignancy

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Study Officials

• Wim Van Biesen, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 20, 2023
• Study Start: January 8, 2024
• Primary Completion: January 31, 2024
• Study Completion: February 15, 2024
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)