OsciPulse D-dimer Pilot Trial

Description

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.

Conditions

Ischemic Stroke

Study Overview

Study Details

Study overview

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.

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

OsciPulse D-dimer Pilot Trial

Condition
Ischemic Stroke
Intervention / Treatment

-

Contacts and Locations

Philadelphia

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Pennsylvania,

Study Record Dates

2026-02