OsciPulse D-dimer Efficacy Trial | NCT05389488

Studies
OsciPulse D-dimer Efficacy Trial

NCT05389488

Sponsor

OsciFlex LLC

Status

Withdrawn

Last Update Posted

Nov 7, 2023Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Venous Thromboses
Ischemic Stroke

Interventions

OsciPulse system
Flowtron ACS900

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

Nov 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Change in funding

Expanded Access Info

Start Date

Dec 2022Estimated

Primary Completion Date

Dec 2022Estimated

Completion Date

Mar 2023Estimated

First Submitted Date

May 20, 2022

First Submission Date that Met QC Criteria

May 20, 2022

First Posted Date

May 25, 2022Actual

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

Nov 2, 2023

Last Update Posted Date

Nov 7, 2023Actual

Name	Class
University of Pennsylvania	OTHER

Description Module

Brief Summary

The purpose of this study is to assess the safety and efficacy of the OsciPulse System in reducing serum d-dimer levels in hospitalized ischemic stroke patients.

Detailed Description

After being informed about the study and potential risks, all patients giving written informed consent will be screened for eligibility. Eligible and enrolled patients who have been admitted to the hospital for an ischemic stroke will be randomized in a non-blinded study to receive compression therapy from either standard-of-care intermittent compression garments, or the OsciPulse System. During the duration of the subject's hospital stay serum d-dimer levels will be monitored serially.

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control Arm	Active Comparator	Subjects will receive standard of care intermittent compression therapy using the current devices used in the clinical space.	Device: Flowtron ACS900
Study Arm	Experimental	Subjects will receive compression therapy from the OsciPulse system.	Device: OsciPulse system

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OsciPulse system	Device	The OsciPulse system is a pneumatic compression system designed to provide intermittent compression to the limbs to augment venous blood flow.	Study Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Relative change in serum d-dimer levels	We will measure the change in serum d-dimer levels over time as a marker of venous coagulation.	7 days

Secondary Outcomes

Measure	Description	Time Frame
Device tolerability	We will measure the number of patients that are compliant with the treatment and quantify their experience with a questionnaire.	7 days

Other Outcomes

Measure	Description	Time Frame
Device Safety event rate	We will monitor for any device related adverse events - skin ulceration, DVT/PE, limb ischemia, etc.	7 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult aged ≥ 18 years old
Admitted to the Neuro Intensive Care Unit or Intermediate Neuro Care Unit with a diagnosis of ischemic stroke
Last known normal < 24 hours.
NIH stroke score ≥5
Weakness in at least one leg (≥ 1 point on the NIHSS lower extremity motor scores, items 6A and 6B)
Prescribed mechanical therapy for DVT prophylaxis.

Exclusion Criteria:

Inability or contraindication to applying IPC to both legs such as:
- Evidence of bone fracture in lower extremities
- Burns in the lower extremities, lacerations, ulcers, active skin infection or dermatitis,
  - ischemic limb in the legs at the site of IPC placement
- Acute ischemia in the lower extremities
- Severe peripheral vascular disease
- Amputated foot or leg on one or two sides
- Compartment syndrome
- Severe lower extremity edema
- Acute deep vein thrombosis
Subjects who received tPA therapy for their stroke
Pregnancy or within 6 weeks of postpartum period
Limitation of life support, life expectancy < 7 days, or in hospice care
A head-unit is unavailable for the first 24 hours or more
At the discretion of the attending physician and / or clinical team, the subject's participation in the study is believed not to be in the best interest of the subject.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
University of Pennsylvania		Philadelphia	Pennsylvania	19146	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

Time Frame

The data will be available following publication of the study results. The data will be available for 24 months.

Access Criteria

The data will be available to university or non-profit researchers.

URL

Not provided

ID	Term
D020246	Venous Thrombosis
D000083242	Ischemic Stroke

ID	Term
D013927	Thrombosis
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases