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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03090984
Recruitment Status : Completed
First Posted : March 27, 2017
Last Update Posted : August 15, 2017
Sponsor:
Information provided by (Responsible Party):
Karlien François, Universitair Ziekenhuis Brussel

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).


Condition or disease Intervention/treatment Phase
End Stage Renal Disease Device: PMMA (BKU) Device: PS (Phylter) Device: AN69ST (Evodial) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Contact Phase Activation During Hemodialysis Using Different Dialysis Membranes: a Prospective Randomized Crossover Study
Actual Study Start Date : May 8, 2017
Actual Primary Completion Date : July 24, 2017
Actual Study Completion Date : July 24, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Active Comparator: PMMA (BKU)

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).

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.

Active Comparator: PS (Phylter)
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.
Device: 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

Active Comparator: AN69ST (Evodial)
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.
Device: 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




Primary Outcome Measures :
  1. Change in contact phase activation induced by hemodialysis treatment, assessed by measurement of plasma kallikrein. [ Time Frame: Blood samples are taken before hemodialysis treatment start and 5minutes (min), 15min, 30min, 90min and 240min after hemodialysis treatment start. ]
    ELISA testing for plasma kallikrein (pg/mL).

  2. Change in contact phase activation induced by hemodialysis treatment, assessed by measurement of plasma fXIa. [ Time Frame: Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start. ]
    Chromogenic test for plasma fXIa (mIU/mL).

  3. Change in contact phase activation induced by hemodialysis treatment, assessed by measurement of plasma fXIIa. [ Time Frame: Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start. ]
    ELISA testing for plasma fXIIa (pg/mL).


Secondary Outcome Measures :
  1. Change in overall coagulation activation induced by hemodialysis treatment, assessed by measurement of plasma TAT. [ Time Frame: Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start. ]
    ELISA testing for plasma TAT (µg/L).

  2. Change in overall coagulation activation induced by hemodialysis treatment, assessed by measurement of plasma PF1+2. [ Time Frame: Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start. ]
    ELISA testing for plasma PF1+2 (pmol/L).

  3. Change in overall coagulation activation induced by hemodialysis treatment, assessed by measurement of plasma d-dimers. [ Time Frame: Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start. ]
    Immunoassay for plasma d-dimers (ng/mL)

  4. Change in extrinsic coagulation activation during hemodialysis treatment assessed by measurement of plasma Tissue Factor [ Time Frame: Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start. ]
    ELISA testing for plasme Tissue Factor (pg/mL)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090984


Locations
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Belgium
UZ Brussel
Jette, Belgium, 1090
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
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Principal Investigator: Karlien François, MD UZ Brussel, Department of Nephrology

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Responsible Party: Karlien François, MD, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT03090984    
Other Study ID Numbers: UZB-NEF-2016-contactphase
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: August 15, 2017
Last Verified: August 2017

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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
Keywords provided by Karlien François, Universitair Ziekenhuis Brussel:
Hemodialysis
Coagulation activation
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency