OsciPulse D-dimer Efficacy Trial

A Randomized Pilot Study of the Efficacy of the OsciPulse System for the Reduction of Serum D-dimer

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.

Study Overview

• Status: Withdrawn
• Conditions: Ischemic Stroke; Venous Thromboses
• Intervention / Treatment: Device: Flowtron ACS900; Device: OsciPulse system

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.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19146
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. 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
2. Subjects who received tPA therapy for their stroke
3. Pregnancy or within 6 weeks of postpartum period
4. Limitation of life support, life expectancy < 7 days, or in hospice care
5. A head-unit is unavailable for the first 24 hours or more
6. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Arm; Subjects will receive standard of care intermittent compression therapy using the current devices used in the clinical space.	Device: Flowtron ACS900; The Arjo Flowtron ACS900 intermittent pneumatic compression system provides compression the calf to augment venous blood flow.
Experimental: Study Arm; Subjects will receive compression therapy from the OsciPulse system.	Device: OsciPulse system; The OsciPulse system is a pneumatic compression system designed to provide intermittent compression to the limbs to augment venous blood flow.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: OsciFlex LLC
• Collaborators: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2022
• Primary Completion (Estimated): December 1, 2022
• Study Completion (Estimated): March 1, 2023

Study Registration Dates

• First Submitted: May 20, 2022
• First Submitted That Met QC Criteria: May 20, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Embolism and Thrombosis; Stroke; Ischemic Stroke; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: OSC-VTE-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: The data will be available following publication of the study results. The data will be available for 24 months.
• IPD Sharing Access Criteria: The data will be available to university or non-profit researchers.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No