RECRUITING

OsciPulse D-dimer Pilot Trial

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-02-12

Study Completion:2026-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06477016

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Steven Messe, MD

CONTACT

215-662-3363

Steven.Messe@pennmedicine.upenn.edu

Nicole Denney, MS

CONTACT

810-831-1044

Nicole.Denney@Pennmedicine.upenn.edu

Study Locations (Sites)

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

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-12

Study Completion Date2026-02

Study Record Updates

Study Start Date2025-02-12

Study Completion Date2026-02

Terms related to this study

Additional Relevant MeSH Terms

Ischemic Stroke