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SOLFA Study to Explore the Thrombogenicity of a Dialyzer

NCT06505616 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-07-17

No results posted yet for this study

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™.

Conditions

  • End Stage Renal Disease on Dialysis

Interventions

DEVICE

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

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.

Sponsors & Collaborators

  • Fundación Senefro

    lead OTHER

Principal Investigators

  • Marta Puerta, MD · University Hospital Infanta Leonor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-17
Primary Completion
2022-02-10
Completion
2023-05-20

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06505616 on ClinicalTrials.gov