Clinical trial NCT06477016: OsciPulse D-dimer Pilot Trial
Official title: A Randomized Pilot Study of the Efficacy of the OsciPulse System for the Reduction of Serum D-dimer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Stroke
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: OsciFlex LLC
First posted: 2024-06-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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.

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.

Primary outcomes:
measure: Change in serum d-dimer levels.
timeFrame: 7 days
Secondary outcomes:
measure: Tolerability of the OsciPulse device in the stroke population
timeFrame: 7 days
measure: Safety of the OsciPulse device in the stroke population
timeFrame: 7 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: HUP Neurology Dept. of Stroke and Neurocritical Care- University of Pennsylvania
state: Pennsylvania
Study officials:
References: