NCT05608096

European Registry for Hemadsorption in Sepsis With the Seraph Filter

European Registry for Hemadsorption of Septic Patients With the Seraph 100 Microbind Affinity Blood Filter (ASTREA Study)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Croatian Society for Organ Support · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

Although new techniques like extracorporeal blood purification have lately emerged, septic patients still have very high hospital mortality rates. Sepsis can be induced by either viremia, bacteriemia or in some cases both. Many studies have reported the effectiveness of different hemadsorbers, but patient sample sizes have been inadequate for definitive conclusions. Secondly, there are still no clear inclusion criteria as well as criteria for when to cease hemadsorption mostly due to immune dysregulation or cascade coagulation disorders. The aim of this observational prospective registry is to evaluate the effectiveness of the Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) in the treatment of septic ICU patients and to evaluate which cluster of these patients should benefit most with this therapy.

Detailed description

Hemadsorption was introduced in everyday clinical practice before the COVID-19 pandemic. The efficacy of hemadsorption removal of endotoxins and cytokines is still, by some, controversial due to the fact that most of the studies were performed in a small number of patients with very different diagnoses, comorbidities and disease severity. Furthemore, some studies enrolled patients over a prolonged period of time with very high SOFA scores and multi-organ failure where it is difficult to expect any significant effect of any kind of organ support therapy. The COSA registry reported that the treatment of COVID-19 patients with Seraph 100 was well tolerated and observed lower mortality in the registry when compared to calculated mortality. The primary aim of this observational prospective, multi-center, multistate web-based registry is to define the effectiveness and outcome of Seraph 100 treatment(s), investigate possible advantages of early targeted treatment and to set indications/inclusion criteria for the treatment of ICU septic patients with the method of hemoadsorption.

Conditions

• Sepsis
• Acute Respiratory Distress Syndrome
• Infections - Pathogen Unspecified
• Disease
• Critical Illness
• Multi Organ Failure
• Systemic Inflammatory Response Syndrome

Interventions

Type	Name	Description
DEVICE	Hemoperfusion	Commercial membrane for extracorporeal blood purification (hemoperfusion)

Timeline

• Start date: 2022-10-25
• Primary completion: 2023-06-30
• Completion: 2025-12-30
• First posted: 2022-11-08
• Last updated: 2022-11-08

Locations

1 site across 1 country: Croatia

Regulatory

• FDA-regulated device study