Evaluation of Contact Phase Activation During Hemodialysis

End Stage Renal Disease Clinical Trial

— c-phact  

Official title:

Evaluation of Contact Phase Activation During Hemodialysis Using Different Dialysis Membranes: a Prospective Randomized Crossover Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03090984
• Other study ID #: UZB-NEF-2016-contactphase
• Status: Completed
• Phase: N/A
• First received: February 10, 2017
• Last updated: August 11, 2017
• Start date: May 8, 2017
• Est. completion date: July 24, 2017

Study information

• Verified date: August 2017
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Every patient included in the study will undergo 3 standardised hemodialysis treatments, each using a different dialysis membrane (PMMA, PS, AN69ST). The order of the membranes used will be randomized.

During each conventional and standardised hemodialysis treatment, 6 blood samples will be taken at different time points (T0, T5, T15, T30, T90, T240) to evaluate coagulation activation (TAT, PF1+2, d-dimers, TF) and, more specifically, activation of the contact phase pathway of coagulation (kallikrein, fXIa, fXIIa).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 24, 2017
• Est. primary completion date: July 24, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients treated with hemodialysis since at least three months.

• Hemodialysis treatment schedule of 3 x 4 hours weekly.

• Arteriovenous fistula (AVF) use for vascular access.

• Treatment with oral acetylsalicylic acid 80 or 100mg q every day.

• = 18 years of age.

• Patients able and agree to provide signed informed consent.

Exclusion Criteria:

• Use of vitamin K antagonists or novel oral anticoagulant therapy.

• Use of chronic heparin treatment, UFH or LMWH.

• Use of clopidogrel.

• Use of ACE-inhibitors.

• Known allergy against one of the dialysis membranes used during this study (PMMA:

BKU®, Toray; PS: Phylter®, Bellco; AN69ST: Evodial®, Gambro).

• Known heparin-induced trombopenia type 2.

• Active infection and/or ongoing systemic antimicrobial treatment.

• Presence of central venous catheter, tunnelled or non-tunnelled and/or AV graft.

• Hospitalized patients.

• Planned surgery during study period.

• Mean Qb of <300ml/min during one of the last 3 dialysis sessions before inclusion.

• Vascular access dysfunction defined as (a) known AV access outflow tract stenosis, (b) planned vascular access intervention, (c) planned vascular access conversion.

• Planned conversion of dialysis modality during study period.

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Device:
• PMMA (BKU)
At serial time points before, during and after each study hemodialysis session using a BKU dialyzer, blood samples will be drawn for coagulation activation analyses.
• PS (Phylter)
At serial time points before, during and after each study hemodialysis session using a Phylter dialyzer, blood samples will be drawn for coagulation activation
• AN69ST (Evodial)
At serial time points before, during and after each study hemodialysis session using an Evodial dialyzer, blood samples will be drawn for coagulation activation

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	Change in contact phase activation induced by hemodialysis treatment, assessed by measurement of plasma kallikrein.	ELISA testing for plasma kallikrein (pg/mL).	Blood samples are taken before hemodialysis treatment start and 5minutes (min), 15min, 30min, 90min and 240min after hemodialysis treatment start.
Primary	Change in contact phase activation induced by hemodialysis treatment, assessed by measurement of plasma fXIa.	Chromogenic test for plasma fXIa (mIU/mL).	Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.
Primary	Change in contact phase activation induced by hemodialysis treatment, assessed by measurement of plasma fXIIa.	ELISA testing for plasma fXIIa (pg/mL).	Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.
Secondary	Change in overall coagulation activation induced by hemodialysis treatment, assessed by measurement of plasma TAT.	ELISA testing for plasma TAT (µg/L).	Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.
Secondary	Change in overall coagulation activation induced by hemodialysis treatment, assessed by measurement of plasma PF1+2.	ELISA testing for plasma PF1+2 (pmol/L).	Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.
Secondary	Change in overall coagulation activation induced by hemodialysis treatment, assessed by measurement of plasma d-dimers.	Immunoassay for plasma d-dimers (ng/mL)	Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.
Secondary	Change in extrinsic coagulation activation during hemodialysis treatment assessed by measurement of plasma Tissue Factor	ELISA testing for plasme Tissue Factor (pg/mL)	Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.