Non- Clinical Coagulation Activation During Hemodialysis

Completed

• Conditions: End Stage Renal Disease; Hemodialysis Complication; Kidney Diseases

• 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

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