Evaluation of Contact Phase Activation During Hemodialysis

NCT ID: NCT03090984

Last Updated: 2017-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-08
• Study Completion Date: 2017-07-24

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

PMMA (BKU)

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

PS (Phylter)

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

AN69ST (Evodial)

Intervention Type: 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

Interventions

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.

Intervention Type: 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

Intervention Type: 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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Karlien François

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karlien François, MD

Role: PRINCIPAL_INVESTIGATOR

UZ Brussel, Department of Nephrology

Locations

UZ Brussel

Jette, , Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 38189593 (View on PubMed)

Other Identifiers

UZB-NEF-2016-contactphase

Identifier Type: -

Identifier Source: org_study_id