OsciPulse D-dimer Efficacy Trial

Phase 2

Withdrawn

• Conditions: Venous Thromboses; Ischemic Stroke
• Interventions: Device: Flowtron ACS900; Device: OsciPulse system

• Registration Number: NCT05389488
• Lead Sponsor: OsciFlex LLC

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.

Study Timeline

• Study First Submitted: 2022-05-20
• Study First Submitted QC: 2022-05-20
• Study First Posted: 2022-05-25
• Study Start: 2022-12
• Primary Completion: 2022-12
• Study Completion: 2023-03
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-02
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Arm	Flowtron ACS900	Subjects will receive standard of care intermittent compression therapy using the current devices used in the clinical space.
Study Arm	OsciPulse system	Subjects will receive compression therapy from the OsciPulse system.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States