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Non- Clinical Coagulation Activation During Hemodialysis

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04063423
Acronym
NC-Coact
Enrollment
32
Registered
2019-08-21
Start date
2018-10-25
Completion date
2019-05-01
Last updated
2019-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease, Hemodialysis Complication, Kidney Diseases

Keywords

clotting, coagulation

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.

Interventions

PROCEDUREblood 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.

Sponsors

Universitair Ziekenhuis Brussel
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
TATFrom first hemodialysis study session until interpretation of biological results, up to 6 monthsthrombin 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.
open fibersFrom first hemodialysis study session until interpretation of scan results, up to 6 monthsnumber 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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026