Non- Clinical Coagulation Activation During Hemodialysis

Completed

• Conditions: End Stage Renal Disease; Hemodialysis Complication; Kidney Diseases
• Interventions: Procedure: blood sample

• Registration Number: NCT04063423
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief Summary

Every patient included in the study will undergo 1 conventional hemodialysis treatment, ie 1 study visit. During the conventional hemodialysis treatment lasting 4 hours, 2 blood samples will be taken at different time points (5 minutes after dialysis start and 240 minutes after dialysis = at the end of the dialysis session) to evaluate coagulation activation (TAT, PF1+2). Hemodialysis session parameters (arterial and venous pressure, TMP, OCM, BVM and prefilter pressure) will be noted at different time points (T5, T30, T60, T120, T180, T240). After discontinuation of the dialysis session, total cell volume will be measured using the Renatron II system® and the number of open fibers will be determined using micro-CT scanning.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-25
• Study First Submitted: 2019-01-22
• Primary Completion: 2019-05-01
• Study Completion: 2019-05-01
• Status Verified: 2019-08
• Study First Submitted QC: 2019-08-20
• Last Update Submitted: 2019-08-20
• Study First Posted: 2019-08-21
• Last Update Posted: 2019-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• ≥ 18 years of age.
• Patients able and agree to provide signed informed consent.

Exclusion Criteria

• Known allergy for polysulphone dialysis membrane.
• Use of vitamin K antagonists or novel oral anticoagulant therapy.
• Use of chronic heparin treatment, UFH or LMWH.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
hemodialysis study session	blood sample	* 4h hemodialysis session using standard polysulphone dialyzer and Nikkiso dialysis monitors * Minimal dose of unfractionated heparin (UFH) with loading dose 500IE and maintenance 500IE/h, stopped 60 minutes before session end in case of AVF use. * Standard bicarbonate-based ultrapure dialysate. Na, K, Ca, bicarbonate concentrations according to the patient's routine dialysis prescription. * The blood flow rate maximized as per routine nursing care. * Dialysate flow rate fixed at 500 ml/min. * Dialysate temperature between 35.5°C and 36.5°C. * Ultrafiltration according to patient's dry weight and supported ultrafiltration rate. * At the end of the dialysis session the blood will be returned (100ml/min) to the patient.

Primary Outcome Measures

Name	Time	Method
open fibers	From first hemodialysis study session until interpretation of scan results, up to 6 months	number of open fibers of dialyzer counted after microCT scanning of dialyzer membrane. Dialyzers were collected after the hemodialysis study treatment. All patients underwent their study treatments between October - December 2018. All micro CT scans were performed using the same scanner in Fabruary and March 2019.
TAT	From first hemodialysis study session until interpretation of biological results, up to 6 months	thrombin antithrombin complex levels (mcg/L). Samples for TAT measurement were taken during the single hemodialysis study treatment. All patients underwent their study treatments between October - December 2018. All analyses were performed in batch in January 2019.

Trial Locations

Locations (1)

UZ Brussel; 🇧🇪 Jette, Belgium