Non- Clinical Coagulation Activation During Hemodialysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-25

Study Completion Date

2019-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Every patient included in the study will undergo 1 conventional hemodialysis treatment, ie 1 study visit. During the conventional hemodialysis treatment lasting 4 hours, 2 blood samples will be taken at different time points (5 minutes after dialysis start and 240 minutes after dialysis = at the end of the dialysis session) to evaluate coagulation activation (TAT, PF1+2). Hemodialysis session parameters (arterial and venous pressure, TMP, OCM, BVM and prefilter pressure) will be noted at different time points (T5, T30, T60, T120, T180, T240). After discontinuation of the dialysis session, total cell volume will be measured using the Renatron II system® and the number of open fibers will be determined using micro-CT scanning.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Coupling Between Clotting Characteristics in Chronic Hemodialysis Patients and the Hemodialyzer Patency

NCT05440201

Bleeding Coagulation

COMPLETED NA

Impact of Clotting on Dialyzer Efficiency

NCT04746391

Hemodialysis Coagulation

COMPLETED NA

Anticoagulation in Chronic Hemodialysis Patients Versus Hemodialyzer Fiber Patency, Bleedings and Quality of Life

NCT05365542

Blood Coagulation

COMPLETED

Optimisation of Anticoagulation in Patients on Nocturnal Hemodialysis

NCT05204810

Hemodialysis Coagulation

COMPLETED NA

Citrate Anticoagulation vs. Heparin-Coated Dialyzers

NCT00395824

Dialysis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Kidney Diseases End Stage Renal Disease Hemodialysis Complication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

hemodialysis study session

* 4h hemodialysis session using standard polysulphone dialyzer and Nikkiso dialysis monitors
* Minimal dose of unfractionated heparin (UFH) with loading dose 500IE and maintenance 500IE/h, stopped 60 minutes before session end in case of AVF use.
* Standard bicarbonate-based ultrapure dialysate. Na, K, Ca, bicarbonate concentrations according to the patient's routine dialysis prescription.
* The blood flow rate maximized as per routine nursing care.
* Dialysate flow rate fixed at 500 ml/min.
* Dialysate temperature between 35.5°C and 36.5°C.
* Ultrafiltration according to patient's dry weight and supported ultrafiltration rate.
* At the end of the dialysis session the blood will be returned (100ml/min) to the patient.

blood sample

Intervention Type PROCEDURE

Blood sample at start and at the end of the dialysis session; membrane scoring after dialysis; total cell volume measurement of dialyzer after dialysis; micro-CT of dialyzer after dialysis.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

blood sample

Blood sample at start and at the end of the dialysis session; membrane scoring after dialysis; total cell volume measurement of dialyzer after dialysis; micro-CT of dialyzer after dialysis.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* ≥ 18 years of age.
* Patients able and agree to provide signed informed consent.

Exclusion Criteria

* Known allergy for polysulphone dialysis membrane.
* Use of vitamin K antagonists or novel oral anticoagulant therapy.
* Use of chronic heparin treatment, UFH or LMWH.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No