ASSET - a Double-Blind, Randomized Placebo-Controlled Clinical Investigation With Alteco® LPS Adsorber

NCT02335723 | Terminated

• 1 other identifier: ALT-CI-01
• Study Type: interventional
• Target: 15
• Locations: 3 countries
• Sites: 6

Brief Summary

The primary objective of this clinical investigation is to investigate the feasibility and possible benefits of the Alteco® LPS Adsorber in treating patients with septic shock with presumed endotoxemia of abdominal or urogenital origin.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• Characterization of all reported USADEs and ASADEs.

  6-28 days

Secondary Outcomes (14)

• Relative change from baseline in plasma endotoxin (p-endotoxin) levels during (i.e. at 2 hours) and immediately after end (i.e. at 6 hours) of treatment with device, on both Day 1 and Day 2.

  2 days

• Relative change from baseline in SOFA score

  6-28 days

• Relative change from baseline in renal function

  6-28 days

• Relative change from baseline in liver function

  6-28 days

• Relative change from baseline in circulatory support

  6-28 days

Study Arms (2)

Alteco LPS Adsorber

ACTIVE COMPARATOR

Hemoperfusion and Standard therapy

Device: Alteco LPS Adsorber

Placebo

PLACEBO COMPARATOR

Placebo and Standard therapy. The placebo comparator device differs from Alteco® LPS Adsorber only in that no peptide component (i.e. active component) has been attached to the matrix.

Device: Placebo

Interventions

Alteco LPS Adsorber DEVICE

Alteco® LPS Adsorber is a Class IIa medical device developed in accordance with existing international standards. Alteco® LPS Adsorber does not contain any pharmaceutical or toxic components. Alteco® LPS Adsorber is used for the adsorption of LPS as endotoxins. The capturing component is a specially designed synthetic peptide developed for adsorption of endotoxin. The capturing component has high affinity to Lipid A, i.e. a constant component in the endotoxin molecule, which ensures efficient reduction of endotoxins from different bacterial species.

Alteco LPS Adsorber

Placebo DEVICE

Exactly the same as Alteco LPS Adsorber but no peptide component has been attached to the matrix (i.e. there is no adsorber functionality)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have suspected severe infection of abdominal or urogenital origin for which the subject is receiving intravenous antimicrobial therapy as the main reason for organ support
• Subjects, males or females, must be 18 years or older.
• Subjects or legally acceptable representatives, as appropriate, are willing and able to provide signed informed consent.
• Appropriate vascular access must have been obtained.
• Subjects must have received ≥ 30 mL/kg of intravenous fluid within the six (6) hours prior to randomization.
• Subjects must have plasma/serum lactate \>2 mmol/L despite adequate resuscitation AND a continuous requirement for vasopressor support
• Subjects must be able to initiate the clinical investigation intervention within 12 hours of fulfilment of the illness severity criteria.

You may not qualify if:

• Vasopressor therapy (at any dose) for longer than 12 hours (not included the time spent in the operation theatre) prior to the start of treatment with the investigational device.
• Pre-existing uncorrectable medical condition as:
• Poorly controlled neoplasms or hematologic disease (i.e. indication of disseminated cancer outside the suspected primary tumour and hematologic disease not in remission,
• End-stage cardiac disease,
• Cardiac arrest requiring cardiopulmonary resuscitation or with pulseless electrical activity or asystole within the past 7 days
• End-stage lung disease
• End-stage liver disease
• HIV/AIDS with known end-stage processes
• Other uncorrectable medical condition(s) deemed by the Clinical Investigator to hinder the subject to adhere to the fulfilment of the activities described in the Clinical Investigation Plan.
• Extreme illness, i.e. subjects is moribund and death is perceived to be imminent (within 24 hours).
• Recent or current participation (≤ 30 days) in another interventional sepsis trial.
• Recent or current treatment (≤ 30 days) with an adsorption product, including Alteco® LPS Adsorber.
• Treatment with an investigational medicinal product for any indication within the last 30 days before enrolment in the clinical investigation.
• Pregnancy.
• Contraindications to the use heparin or protamine

Sponsors & Collaborators

• Alteco Medical AB: lead
• TFS Trial Form Support: collaborator
• Uppsala University: collaborator

Study Sites (6)

Kuopio University Hospital

Kuopio, 70210, Finland

Location

Tampere University Hospital

Tampere, 33521, Finland

Location

Haukeland Universitetssykehus

Bergen, 5021, Norway

Location

Oslo Universitetssykehus

Oslo, 0372, Norway

Location

Linköping University Hospital

Linköping, SE-58185, Sweden

Location

Uppsala University Hospital

Uppsala, SE-751 81, Sweden

Location

Related Publications (2)

• Lipcsey M, Tenhunen J, Pischke SE, Kuitunen A, Flaatten H, De Geer L, Sjolin J, Frithiof R, Chew MS, Bendel S, Kawati R, Larsson A, Mollnes TE, Tonnessen TI, Rubertsson S. Endotoxin Removal in Septic Shock with the Alteco LPS Adsorber Was Safe But Showed no Benefit Compared to Placebo in the Double-Blind Randomized Controlled Trial-the Asset Study. Shock. 2020 Aug;54(2):224-231. doi: 10.1097/SHK.0000000000001503.

  PMID: 31880758 DERIVED

• Lipcsey M, Tenhunen J, Sjolin J, Frithiof R, Bendel S, Flaatten H, Kawati R, Kuitunen A, Tonnessen TI, Rubertsson S. Abdominal Septic Shock - Endotoxin Adsorption Treatment (ASSET) - endotoxin removal in abdominal and urogenital septic shock with the Alteco(R) LPS Adsorber: study protocol for a double-blinded, randomized placebo-controlled trial. Trials. 2016 Dec 8;17(1):587. doi: 10.1186/s13063-016-1723-4.

  PMID: 27931259 DERIVED

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Sten Rubertsson, Professor

  Uppsala University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2014
• First Posted: January 12, 2015
• Study Start: September 1, 2015
• Primary Completion: April 28, 2017
• Study Completion: April 28, 2017
• Last Updated: March 7, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2); NO (2); FI (2)