CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 32 enrolled
Drug / intervention
Compared the trombogenicity of the Solacea dialyzer with synthetic dialyzers after progressively decreasing heparin until discontinuing itdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06505616
NCT06505616N/ACompleted
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SOLFA Study: A Multicenter, Open-label, Prospective, Randomized Study to Explore the Clotting Propensity of Solacea™ Dialyser Comparing With Synthetic Membranes

Fundación Senefro·interventional·Posted Jul 17, 2024·Updated Jul 17, 2024

In Brief

A clinical study evaluating Compared the trombogenicity of the Solacea dialyzer with synthetic dialyzers after progressively decreasing heparin until discontinuing it for End Stage Renal Disease on Dialysis. Completed, enrolled 32 participants across 1 site.

Detailed Summary

Prospective, multicenter, randomized, crossover, non-masked study to evaluate the impact on the thrombogenicity of the haemodialysis circuit by comparing synthetic haemodialysers against the ATA membrane of the Solacea™.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEnd Stage Renal Disease on Dialysis
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJul 17, 2024
Enrollment StartJan 17, 2022
Primary CompletionFeb 10, 2022
Study CompletionMay 20, 2023
TodayJul 2, 2026
Enrollment to primary: 23 daysPosted 2.0 years ago

Interventions

Compared the trombogenicity of the Solacea dialyzer with synthetic dialyzers after progressively decreasing heparin until discontinuing itdevice

The duration of the study was four weeks, carried out in two phases. After screening, patients were randomized to be dialyzed with the Solacea™ hemodialyzer versus the usual hemodialyzer, which in all cases had to be a synthetic membrane. In both arms, heparin was progressively decreased until it was discontinued. Afterwards the patients were crossed over to the other arm.