An interventional study of Heparin free dialysis technique and Evodial in Chronic Kidney Disease and Patients Requiring Heparin Free Dialysis Treatments, sponsored by Vantive Health LLC. Completed at 10 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-14.
Sponsored by Vantive Health LLC · Not applicable, Interventional, and Treatment
The study hypothesis is that with Evodial in patients requiring heparin free dialysis, the heparin free treatment can be performed easily (without saline flushes or blood predilution) and is at least not inferior and maybe superior to the standard care heparin free treatment in terms of clotting.
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Exclusion Criteria:
Standard of care: can be either saline flushes or predilution (on-line or bags)
Other: Heparin free dialysis technique
Device: Evodial
Saline flushes or predilution
Also known as: Standard of care
Evodial dialyer
Clotting of the dialysis session
To evaluate the rate of successful treatments, clotting in the air traps will be evaluated using a scale grading from 1 to 4 and previously described in the literature. The first heparin free dialysis treatment will be considered successful when there is: * No complete occlusion of air traps or dialyzer rendering dialysis impossible (grade 4 of the scale), * No additional saline flushes to prevent clotting, * No change of dialyzer or blood lines because of clotting * No premature stop (early rinse-back) because of clotting
Time frame: During first dialysis session_Dialysis duration: 4 hours
Clotting during consecutive dialysis session
As for the first heparin free dialysis treatment, treatments will be considered successful when there is : * No complete occlusion of air traps or dialyzer rendering dialysis impossible (grade 4 of the scale), * No additional saline flushes to prevent clotting, * No change of dialyzer or blood lines because of clotting * No premature stop (early rinse-back) because of clotting.
Time frame: 2nd and 3rd consecutive dialysis sessions
Follow up of clotting during the dialysis sessions
* Grade 1: No detectable clotting * Grade 2: Minimal clot formation (Presence of fibrinous ring) * Grade 3: Clot formation (up to 5 cm) but dialysis still possible * Grade 4: complete occlusion of air traps or dialyzer rendering dialysis impossible
Time frame: During all dialysis sessions
Efficacy: Ultrafiltration
Measurement of urea, creatinine and ionogramm, UF achieved
Time frame: During all dialysis sessions
Ease of use
Collection of saline flushes performed (volume and time)
Time frame: During all dialysis sessions
Incidence of AEs/SAEs
Follow-up of AEs/SAEs
Time frame: During all dialysis sessions
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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