Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06505616
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-06-05
Brief Title:
SOLFA Study to Explore the Thrombogenicity of a Dialyzer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
SOLFA Study A Multicenter Open-label Prospective Randomized Study to Explore the Clotting Propensity of Solacea Dialyser Comparing With Synthetic Membranes
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
This is a prospective multicenter randomized crossover non-masked study that included 32 patients from 4 Spanish hospitals
The objective of the present work is to evaluate the impact on the thrombogenicity of the haemodialysis circuit by comparing synthetic haemodialysers against the ATA membrane of the Solacea
Study population Patients over 18 years of age in a chronic haemodialysis program who had been on dialysis for more than three months were included All patients provided informed consent The study was approved by the local Ethics Committee and was conducted according to the principles of the Declaration of Helsinki The exclusion criteria were allergies to synthetic membranes and allergies to heparin patients receiving anticoagulant treatment women Pregnant breastfeeding or patients with cognitive impairment
In each of the two phases of six consecutive two-week HD sessions patients were dialyzed according to their usual schedule with the haemodialyser assigned after randomization synthetic vs ATA membrane During the six sessions of both phases the dose of heparin was progressively reduced 100 usual heparin dose in the first session until sixth session without heparin
After each session carried out a visual inspection of the venous chamber and the haemodialyser and assigned a coagulation score previously published Dialyser score from 0 completly clean 0 coagulated fibers to 4 100 coagulated fibers Venous chamber score from 0 clean without clotting to 3 complete oclusión dialysis is not possible
Demographic data and dialysis parameters were also collected The dialyzers from 8 patients were collected at the beginning and end of each study arm and scanned with a reference non-invasive micro-CT Computed Tomography scanning technique
The objective of the present work is to evaluate the impact on the thrombogenicity of the haemodialysis circuit by comparing synthetic haemodialysers against the ATA membrane of the Solacea
Study population Patients over 18 years of age in a chronic haemodialysis program who had been on dialysis for more than three months were included All patients provided informed consent The study was approved by the local Ethics Committee and was conducted according to the principles of the Declaration of Helsinki The exclusion criteria were allergies to synthetic membranes and allergies to heparin patients receiving anticoagulant treatment women Pregnant breastfeeding or patients with cognitive impairment
In each of the two phases of six consecutive two-week HD sessions patients were dialyzed according to their usual schedule with the haemodialyser assigned after randomization synthetic vs ATA membrane During the six sessions of both phases the dose of heparin was progressively reduced 100 usual heparin dose in the first session until sixth session without heparin
After each session carried out a visual inspection of the venous chamber and the haemodialyser and assigned a coagulation score previously published Dialyser score from 0 completly clean 0 coagulated fibers to 4 100 coagulated fibers Venous chamber score from 0 clean without clotting to 3 complete oclusión dialysis is not possible
Demographic data and dialysis parameters were also collected The dialyzers from 8 patients were collected at the beginning and end of each study arm and scanned with a reference non-invasive micro-CT Computed Tomography scanning technique
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None