Non- Clinical Coagulation Activation During Hemodialysis (NC-Coact)

Non- Clinical Coagulation Activation During Hemodialysis: a Cross-sectional Study Evaluating Agreement and Correlation Between Hemodialysis Session Parameters, Biological Markers and Objective Measurements of Hemodialyzers: "NC-coact"

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.

Study Overview

• Status: Completed
• Conditions: Kidney Diseases; End Stage Renal Disease; Hemodialysis Complication
• Intervention / Treatment: Procedure: blood sample

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• Belgium
  • Jette, Belgium, 1090
    • UZ Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with end stage renal disease treated with hemodialysis

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

hemodialysis study session; 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.

Procedure: blood sample; Blood sample at start and at the end of the dialysis session; membrane scoring after dialysis; total cell volume measurement of dialyzer after dialysis; micro-CT of dialyzer after dialysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TAT	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.	From first hemodialysis study session until interpretation of biological results, up to 6 months
open fibers	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.	From first hemodialysis study session until interpretation of scan results, up to 6 months

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2018
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: January 22, 2019
• First Submitted That Met QC Criteria: August 20, 2019
• First Posted (Actual): August 21, 2019

Study Record Updates

• Last Update Posted (Actual): August 21, 2019
• Last Update Submitted That Met QC Criteria: August 20, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: coagulation; clotting
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: UZB-NEF-2018-NC-COACT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No