OsciPulse D-dimer Pilot Trial

NCT ID: NCT06477016

Last Updated: 2025-06-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-12
• Study Completion Date: 2026-02-28

Brief Summary

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.

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.

Conditions

Ischemic Stroke

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

OsciPulse

Intervention Type: DEVICE

Non-invasive device that provides rapid pulses of compression of the calves to modify venous blood flow patterns in immobilized persons.

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.

Intermittent Pneumatic Compression

Intervention Type: DEVICE

Non-invasive device that provides rapid pulses of compression of the calves to modify venous blood flow patterns in immobilized persons.

Interventions

OsciPulse

Non-invasive device that provides rapid pulses of compression of the calves to modify venous blood flow patterns in immobilized persons.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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)

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 (e.g. Alteplase or Tenecteplase) 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 last known normal. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OsciFlex LLC

INDUSTRY

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

HUP Neurology Dept. of Stroke and Neurocritical Care- University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Steven Messe, MD

Role: CONTACT

Steven.Messe@pennmedicine.upenn.edu

215-662-3363

Nicole Denney, MS

Role: CONTACT

Nicole.Denney@Pennmedicine.upenn.edu

810-831-1044

Facility Contacts

Steven Messe, MD

Role: primary

Steven.Messe@pennmedicine.upenn.edu

215-662-3363

Other Identifiers

OSC-VTE-003

Identifier Type: -

Identifier Source: org_study_id