NCT06477016

OsciPulse D-dimer Pilot Trial

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2025-02-12
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2024-06-27
• Last updated: 2026-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study