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

U

Universitair Ziekenhuis Brussel

Status

Completed

Conditions

Hemodialysis Complication
Kidney Diseases
End Stage Renal Disease

Treatments

Procedure: blood sample

Study type

Observational

Funder types

Other

Identifiers

NCT04063423
UZB-NEF-2018-NC-COACT

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

32 participants in 1 patient group

hemodialysis study session
Description:
* 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.
Treatment:
Procedure: blood sample

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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