OsciPulse D-dimer Pilot Trial

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

Pilot, randomized, non-blinded clinical trial to generate preliminary data to evaluate the impact of the OsciPulse system on serum d-dimer levels compared to standard of care intermittent compression therapy for DVT prophylaxis in patients admitted in the neuro ICU or intermediate neurological care unit with acute ischemic stroke.

Study Overview

• Status: Active, not recruiting
• Conditions: Ischemic Stroke
• Intervention / Treatment: Device: OsciPulse; Device: Intermittent Pneumatic Compression

Detailed Description

This is a single site, randomized open label two arm study. The patient population will be randomly divided into two arms, with one receiving the OsciPulse System and the other receiving standard intermittent compression therapy.

Both arms will have the therapy applied within 24 hours of admission and continue during their hospital stay until day 7 or discharge, whichever is shorter, unless clinically required to be removed. Daily d-dimer levels will be assessed until day 7 or discharge. If required beyond day 7, standard compression therapy will be provided. An interim analysis will be performed after 20 subjects are enrolled to evaluate the speed of enrollment and data variability and quality. If indicated, enrollment will be increased up to 40.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • HUP Neurology Dept. of Stroke and Neurocritical Care- University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Study Population

All subjects admitted to the Neuro ICU or Intermediate Neuro Care Unit with a diagnosis of acute stroke will be screened for enrollment.

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. < 24 hours from last known normal or treating-hospital admission.
4. NIH stroke score ≥5
5. Weakness in at least one leg (≥ 1 point on the NIHSS lower extremity motor scores)
6. Prescribed mechanical therapy for DVT prophylaxis.

Exclusion Criteria:

1. Inability or contraindication to applying IPC to both legs such as:

• Evidence of acute bone fracture in lower extremities
• Acute burns in the lower extremities, lacerations, ulcers, active skin infection or dermatitis, in the lower extremities at the site of IPC placement
• Acute ischemia or severe peripheral vascular disease in the lower extremities as evidenced by cyanotic, cool, pulselessness.
• Amputated foot or leg on one or two sides
• Compartment syndrome (acute injury causing swelling and ischemic injury)
• Severe lower extremity edema (+4 edema as documented by clinical team)
• Acute deep vein thrombosis 2. Subjects who received thrombolytic therapy for their stroke 3. Known 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 within 24 hours of study enrollment. 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
Experimental: Group A-OsciPulse System; Patients admitted to the neuro intensive care unit or intermediate neurological care unit with a diagnosis of ischemic stroke randomly assigned to Group A.	Device: OsciPulse; Non-invasive device that provides rapid pulses of compression of the calves to modify venous blood flow patterns in immobilized persons.
Active Comparator: Group B- Standard Reference Therapy; Patients admitted to the neuro intensive care unit or intermediate neurological care unit with a diagnosis of ischemic stroke randomly assigned to Group B.	Device: Intermittent Pneumatic Compression; Non-invasive device that provides rapid pulses of compression of the calves to modify venous blood flow patterns in immobilized persons.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in serum d-dimer levels.	Relative change in serum d-dimer levels for each subject from baseline to Day 7 or discharge	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability of the OsciPulse device in the stroke population	Tolerability defined as the number of patients who stop using the device prior to clinical recommendation and by quantitative scoring of subject experience questionnaires.	7 days
Safety of the OsciPulse device in the stroke population	Comparison of the rate of Adverse Events (AE) between the two groups.	7 days

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: OsciFlex LLC
• Investigators: Principal Investigator: Steven Messe, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: June 20, 2024
• First Submitted That Met QC Criteria: June 20, 2024
• First Posted (Actual): June 27, 2024

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke; Equipment and Supplies; Intermittent Pneumatic Compression Devices
• Other Study ID Numbers: OSC-VTE-003

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