Optimisation of Anticoagulation in Patients on Nocturnal Hemodialysis

NCT05204810 | Completed

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

Brief Summary

To avoid clotting during extracorporeal treatment, an anticoagulant is added to the circuit, resulting in an increased risk for bleeding complications. In addition, there is evidence that a substantial number of fibers can become blocked before this is reflected in routinely observed parameters, or in termination of the dialysis session. In standard hemodialysis of 4 hours, the anticoagulant is administered at the beginning of dialysis. For nocturnal hemodialysis, there is no hard evidence whether anticoagulation should be administered only at the dialysis start or with an extra dosing halfway the dialysis session. The aim of this randomized cross-over study is to objectively quantify the number of patent fibers after nocturnal dialysis in two different settings: anticoagulation only at the dialysis start, and anticoagulation divided over two time points, i.e. dialysis start and halfway dialysis.

Conditions

Hemodialysis; Coagulation

Keywords

Hemodialyzer; Fibre Clotting; Nocturnal dialysis

Outcome Measures

Primary Outcomes (1)

• Percentage of open fibers in hemodialyzer

  By scanning the hemodialyzers post dialysis using a reference micro-CT scanning technique, images are obtained from dialyzer cross-sections. Black dots can be counted as open fiber. By counting the number of open fibers and relating this number with the total numerb of fibers in sterile dialyzers, the percentage of open fibers can be quantified.

  2 weeks

Secondary Outcomes (1)

• Absolute value and change of the clotting parameter antiXa at different time points during dialysis

  2 weeks

Study Arms (2)

Night_1dosis

EXPERIMENTAL

* anticoagulation at dialysis start * blood sampling 5min after start dosis, and at 1h, 4h and 8h after dialysis start * microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers

Other: Anticoagulation strategy; Other: Blood sampling; Other: Scanning of hemodialyzer with micro-computed tomography

Night_2doses

EXPERIMENTAL

* anticoagulation split over dialysis start and halfway dialysis (after 4h) * blood sampling 5min after start dosis, and at 1h, 4h (1 sample before and 1 sample after the extra anticoagulant dosis) and 8h after dialysis start * microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers

Other: Anticoagulation strategy; Other: Blood sampling; Other: Scanning of hemodialyzer with micro-computed tomography

Interventions

Anticoagulation strategy OTHER

For each session of this cross-over study, a different anticoagulation therapy is used: either 1 dose of anticoagulant or 2 doses of anticoagulant

Night_1dosis; Night_2doses

Blood sampling OTHER

During the study sessions, blood sampling is performed from the arterial blood line at different time points (5min, 60min, 240min and at the dialysis end)

Night_1dosis; Night_2doses

Scanning of hemodialyzer with micro-computed tomography OTHER

After the study sessions, the used hemodialyzers are scanned using a gold standard micro computed tomography technique.

Night_1dosis; Night_2doses

Eligibility Criteria

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

You may qualify if:

• years or older
• experienced stable dialysis sessions during the last 4 weeks
• nocturnal in-centre hemodialysis
• well functioning vascular access

You may not qualify if:

• known coagulation disorder
• active inflammation
• malignancy
• no coumarin-derived medication

Sponsors & Collaborators

• University Hospital, Ghent: lead
• University Ghent: collaborator

Study Sites (1)

Ghent University Hospital - Nephrology

Ghent, Belgium

Location

MeSH Terms

Conditions

Thrombosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Wim Van Biesen, Prof dr

  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: December 9, 2021
• First Posted: January 24, 2022
• Study Start: February 1, 2022
• Primary Completion: March 1, 2022
• Study Completion: April 1, 2022
• Last Updated: May 24, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)