Non- Clinical Coagulation Activation During Hemodialysis

End Stage Renal Disease Clinical Trial

— NC-Coact  

Official title:

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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04063423
• Other study ID #: UZB-NEF-2018-NC-COACT
• Status: Completed
• Start date: October 25, 2018
• Est. completion date: May 1, 2019

Study information

• Verified date: August 2019
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Renal Disease
• Hemodialysis Complication
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

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.

Locations

Country	Name	City	State
Belgium	UZ Brussel	Jette

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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