search
Back to results

Evaluation of Contact Phase Activation During Hemodialysis (c-phact)

Primary Purpose

End Stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
PMMA (BKU)
PS (Phylter)
AN69ST (Evodial)
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for End Stage Renal Disease focused on measuring Hemodialysis, Coagulation activation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UZ Brussel

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

PMMA (BKU)

PS (Phylter)

AN69ST (Evodial)

Arm Description

Patients included in the study will undergo 3 hemodialysis treatments. During the PMMA Arm, patient will be dialyzed using a BKU 1.6 (Toray) dialyzer. All study treatments will be standardized for dialysis access, priming procedure, blood and dialysate flows, anticoagulation therapy and duration of the hemodialysis session. During each study treatment, blood samples will be taken at specified time points (T0, T5, T15, T30, T90, T240) to assess overall coagulation activation (TAT, PF1+2, d-dimers), contact phase activation (kallikrein, fXIa, fXIIa), and activation of the extrinsic coagulation pathway (TF).

Patients included in the study will undergo 3 hemodialysis treatments. During the PS Arm, patient will be dialyzed using a Phylter 1.7 (Bellco) dialyzer. All study treatments will be standardized for dialysis access, priming procedure, blood and dialysate flows, anticoagulation therapy and duration of the hemodialysis session.

Patients included in the study will undergo 3 hemodialysis treatments. During the AN69ST Arm, patient will be dialyzed using a Evodial 1.6 (Gambro) dialyzer. All study treatments will be standardized for dialysis access, priming procedure, blood and dialysate flows, anticoagulation therapy and duration of the hemodialysis session.

Outcomes

Primary Outcome Measures

Change in contact phase activation induced by hemodialysis treatment, assessed by measurement of plasma kallikrein.
ELISA testing for plasma kallikrein (pg/mL).
Change in contact phase activation induced by hemodialysis treatment, assessed by measurement of plasma fXIa.
Chromogenic test for plasma fXIa (mIU/mL).
Change in contact phase activation induced by hemodialysis treatment, assessed by measurement of plasma fXIIa.
ELISA testing for plasma fXIIa (pg/mL).

Secondary Outcome Measures

Change in overall coagulation activation induced by hemodialysis treatment, assessed by measurement of plasma TAT.
ELISA testing for plasma TAT (µg/L).
Change in overall coagulation activation induced by hemodialysis treatment, assessed by measurement of plasma PF1+2.
ELISA testing for plasma PF1+2 (pmol/L).
Change in overall coagulation activation induced by hemodialysis treatment, assessed by measurement of plasma d-dimers.
Immunoassay for plasma d-dimers (ng/mL)
Change in extrinsic coagulation activation during hemodialysis treatment assessed by measurement of plasma Tissue Factor
ELISA testing for plasme Tissue Factor (pg/mL)

Full Information

First Posted
February 10, 2017
Last Updated
August 11, 2017
Sponsor
Universitair Ziekenhuis Brussel
search

1. Study Identification

Unique Protocol Identification Number
NCT03090984
Brief Title
Evaluation of Contact Phase Activation During Hemodialysis
Acronym
c-phact
Official Title
Evaluation of Contact Phase Activation During Hemodialysis Using Different Dialysis Membranes: a Prospective Randomized Crossover Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 8, 2017 (Actual)
Primary Completion Date
July 24, 2017 (Actual)
Study Completion Date
July 24, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
Hemodialysis, Coagulation activation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PMMA (BKU)
Arm Type
Active Comparator
Arm Description
Patients included in the study will undergo 3 hemodialysis treatments. During the PMMA Arm, patient will be dialyzed using a BKU 1.6 (Toray) dialyzer. All study treatments will be standardized for dialysis access, priming procedure, blood and dialysate flows, anticoagulation therapy and duration of the hemodialysis session. During each study treatment, blood samples will be taken at specified time points (T0, T5, T15, T30, T90, T240) to assess overall coagulation activation (TAT, PF1+2, d-dimers), contact phase activation (kallikrein, fXIa, fXIIa), and activation of the extrinsic coagulation pathway (TF).
Arm Title
PS (Phylter)
Arm Type
Active Comparator
Arm Description
Patients included in the study will undergo 3 hemodialysis treatments. During the PS Arm, patient will be dialyzed using a Phylter 1.7 (Bellco) dialyzer. All study treatments will be standardized for dialysis access, priming procedure, blood and dialysate flows, anticoagulation therapy and duration of the hemodialysis session.
Arm Title
AN69ST (Evodial)
Arm Type
Active Comparator
Arm Description
Patients included in the study will undergo 3 hemodialysis treatments. During the AN69ST Arm, patient will be dialyzed using a Evodial 1.6 (Gambro) dialyzer. All study treatments will be standardized for dialysis access, priming procedure, blood and dialysate flows, anticoagulation therapy and duration of the hemodialysis session.
Intervention Type
Device
Intervention Name(s)
PMMA (BKU)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
PS (Phylter)
Intervention Description
At serial time points before, during and after each study hemodialysis session using a Phylter dialyzer, blood samples will be drawn for coagulation activation
Intervention Type
Device
Intervention Name(s)
AN69ST (Evodial)
Intervention Description
At serial time points before, during and after each study hemodialysis session using an Evodial dialyzer, blood samples will be drawn for coagulation activation
Primary Outcome Measure Information:
Title
Change in contact phase activation induced by hemodialysis treatment, assessed by measurement of plasma kallikrein.
Description
ELISA testing for plasma kallikrein (pg/mL).
Time Frame
Blood samples are taken before hemodialysis treatment start and 5minutes (min), 15min, 30min, 90min and 240min after hemodialysis treatment start.
Title
Change in contact phase activation induced by hemodialysis treatment, assessed by measurement of plasma fXIa.
Description
Chromogenic test for plasma fXIa (mIU/mL).
Time Frame
Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.
Title
Change in contact phase activation induced by hemodialysis treatment, assessed by measurement of plasma fXIIa.
Description
ELISA testing for plasma fXIIa (pg/mL).
Time Frame
Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.
Secondary Outcome Measure Information:
Title
Change in overall coagulation activation induced by hemodialysis treatment, assessed by measurement of plasma TAT.
Description
ELISA testing for plasma TAT (µg/L).
Time Frame
Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.
Title
Change in overall coagulation activation induced by hemodialysis treatment, assessed by measurement of plasma PF1+2.
Description
ELISA testing for plasma PF1+2 (pmol/L).
Time Frame
Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.
Title
Change in overall coagulation activation induced by hemodialysis treatment, assessed by measurement of plasma d-dimers.
Description
Immunoassay for plasma d-dimers (ng/mL)
Time Frame
Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.
Title
Change in extrinsic coagulation activation during hemodialysis treatment assessed by measurement of plasma Tissue Factor
Description
ELISA testing for plasme Tissue Factor (pg/mL)
Time Frame
Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karlien François, MD
Organizational Affiliation
UZ Brussel, Department of Nephrology
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Brussel
City
Jette
ZIP/Postal Code
1090
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Contact Phase Activation During Hemodialysis

We'll reach out to this number within 24 hrs