OsciPulse D-dimer Efficacy Trial

NCT05389488 | Withdrawn Phase 2 FDA Device

• 1 other identifier: OSC-VTE-003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Thromboses; Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Device tolerability

  7 days

Other Outcomes (1)

• Device Safety event rate

  7 days

Study Arms (2)

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

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

Flowtron ACS900 DEVICE

The Arjo Flowtron ACS900 intermittent pneumatic compression system provides compression the calf to augment venous blood flow.

Control Arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• OsciFlex LLC: lead
• University of Pennsylvania: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19146, United States

Location

MeSH Terms

Conditions

Venous Thrombosis; Ischemic Stroke

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: May 25, 2022
• Study Start: December 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: March 1, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

US (1)