Safety and Efficacy of SCD in AKI or ARDS Patients Associ... | NCT04395911

Studies
Safety and Efficacy of SCD in AKI or ARDS Patients Associated With COVID-19 Infections

NCT04395911

Sponsor

SeaStar Medical

Status

Completed

Last Update Posted

Aug 5, 2021Actual

Enrollment

22Actual

Phase

Not Applicable

Conditions

AKI
ARDS
COVID

Interventions

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 10, 2020Actual

Primary Completion Date

Jul 5, 2021Actual

Completion Date

Jul 21, 2021Actual

First Submitted Date

May 17, 2020

First Submission Date that Met QC Criteria

May 18, 2020

First Posted Date

May 20, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 4, 2021

Last Update Posted Date

Aug 5, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Label	Type	Description	Intervention Names
SCD	Other	Cytopheretic device	Device: SCD

Name	Type	Description	Arm Group Labels	Other Names
SCD	Device	cytopheretic device	SCD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality at Day 60	All cause mortality at Day 60	60 days post treatment
Dialysis Dependency	Dialysis Dependency at Day 60	60 days post treatment
Ventilation at Day 28	Ventilation free survival at Day 28	28 days post treatment

Secondary Outcomes

Measure	Description	Time Frame
Dialysis Dependency	Dialysis Dependency at Day 28	28 days post treatment
Mortality at Day 28	All cause mortality at Day 28	28 days post treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Informed consent obtained
Positive COVID-19 test
Must be receiving medical care in an intensive care nursing situation
Non-pregnant females
Intent to deliver full supportive care through aggressive management utilizing all available therapies for a minimum of 96 hours.
Platelet count >30,000/mm3 at Screening
Clinical diagnosis of AKI requiring CRRT or ARDS

Exclusion Criteria:

Cardiovascular instability that precludes initiation of continuous renal replacement therapy (CRRT).
Irreversible brain damage based on available historical and clinical information.
Presence of any solid organ transplant at any time.
Patients with stem cell transplant in the previous 100 days or who have not engrafted.
Acute or chronic use of circulatory support device other than ECMO such as LVADs, RVADs, BIVADs.
Metastatic malignancy which is actively being treated or may be treated with chemotherapy or radiation during the subsequent three month period after study treatment.
Chronic immunosuppression defined as >20 mg prednisone qd alone without other immunosuppressant medications (ie (cyclophosphamide, azathioprine, methotrexate, rituximab, mycophenolate, cyclosporine).
Patient is moribund or chronically debilitated for whom full supportive care is not indicated.
Concurrent enrollment in another interventional clinical trial. Patients enrolled in observational studies (NO TEST DEVICE OR DRUG USED) are allowed to participate.
Any reason the Investigator deems exclusionary.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
University of Kentucky		Lexington	Kentucky	40506	United States
University of Michigan

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Unidentified participant data collected for this study will be submitted to a CRO for data analysis. All data will be submitted to the Sponsor.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Time Frame

Data will be collected throughout the study conduct.

Access Criteria

Participant data will be accessible to the Investigational Site and CRO through a secured electronic data capture system. CRO personnel will be responsible for data verification. De-identified Participant information will be accessible to the CRO and the Sponsor.

URL

Not provided