Non- Clinical Coagulation Activation During Hemodialysis

NCT04063423 | Completed

• 1 other identifier: UZB-NEF-2018-NC-COACT
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Diseases; End Stage Renal Disease; Hemodialysis Complication

Keywords

clotting; coagulation

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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

Interventions

blood sample PROCEDURE

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.

hemodialysis study session

Eligibility Criteria

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

Study Population

patients with end stage renal disease treated with hemodialysis

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Jette, 1090, Belgium

Location

MeSH Terms

Conditions

Kidney Diseases; Kidney Failure, Chronic; Thrombosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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 Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: August 21, 2019
• Study Start: October 25, 2018
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: August 21, 2019

Record last verified: 2019-08

Locations

BE (1)