Evaluation of Contact Phase Activation During Hemodialysis

NCT03090984 | Completed

• 1 other identifier: UZB-NEF-2016-contactphase
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

End Stage Renal Disease

Keywords

Hemodialysis; Coagulation activation

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (4)

• Change in overall coagulation activation induced by hemodialysis treatment, assessed by measurement of plasma TAT.

  Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.

• Change in overall coagulation activation induced by hemodialysis treatment, assessed by measurement of plasma PF1+2.

  Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.

• Change in overall coagulation activation induced by hemodialysis treatment, assessed by measurement of plasma d-dimers.

  Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.

• Change in extrinsic coagulation activation during hemodialysis treatment assessed by measurement of plasma Tissue Factor

  Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.

Study Arms (3)

PMMA (BKU)

ACTIVE COMPARATOR

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)

PS (Phylter)

ACTIVE COMPARATOR

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)

AN69ST (Evodial)

ACTIVE COMPARATOR

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)

Interventions

PMMA (BKU) DEVICE

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.

PMMA (BKU)

PS (Phylter) DEVICE

At serial time points before, during and after each study hemodialysis session using a Phylter dialyzer, blood samples will be drawn for coagulation activation

PS (Phylter)

AN69ST (Evodial) DEVICE

At serial time points before, during and after each study hemodialysis session using an Evodial dialyzer, blood samples will be drawn for coagulation activation

AN69ST (Evodial)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Jette, 1090, Belgium

Location

Related Publications (1)

• Natale P, Palmer SC, Ruospo M, Longmuir H, Dodds B, Prasad R, Batt TJ, Jose MD, Strippoli GF. Anticoagulation for people receiving long-term haemodialysis. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD011858. doi: 10.1002/14651858.CD011858.pub2.

  PMID: 38189593 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karlien François, MD

  UZ Brussel, Department of Nephrology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: March 27, 2017
• Study Start: May 8, 2017
• Primary Completion: July 24, 2017
• Study Completion: July 24, 2017
• Last Updated: August 15, 2017

Record last verified: 2017-08

Locations

BE (1)