OsciPulse D-dimer Efficacy Trial

• Sponsor: OsciFlex LLC (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05389488
• Collaborator: University of Pennsylvania (Other)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 9
• Patients Per Site Per Month: 4.5

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety and efficacy of the OsciPulse System in reducing serum d-dimer levels in hospitalized ischemic stroke patients.

Condition or Disease	Intervention/Treatment	Phase
Venous Thromboses; Ischemic Stroke	Device: OsciPulse system; Device: Flowtron ACS900	Phase 2

Detailed Description

After being informed about the study and potential risks, all patients giving written informed consent will be screened for eligibility. Eligible and enrolled patients who have been admitted to the hospital for an ischemic stroke will be randomized in a non-blinded study to receive compression therapy from either standard-of-care intermittent compression garments, or the OsciPulse System. During the duration of the subject's hospital stay serum d-dimer levels will be monitored serially.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Randomized Pilot Study of the Efficacy of the OsciPulse System for the Reduction of Serum D-dimer
• Anticipated Study Start Date: Jun 1, 2022
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control Arm Subjects will receive standard of care intermittent compression therapy using the current devices used in the clinical space.	Device: Flowtron ACS900; The Arjo Flowtron ACS900 intermittent pneumatic compression system provides compression the calf to augment venous blood flow.
Experimental: Study Arm Subjects will receive compression therapy from the OsciPulse system.	Device: OsciPulse system; The OsciPulse system is a pneumatic compression system designed to provide intermittent compression to the limbs to augment venous blood flow.

Outcome Measures

Primary Outcome Measures

1. Relative change in serum d-dimer levels [7 days]

   We will measure the change in serum d-dimer levels over time as a marker of venous coagulation.

Secondary Outcome Measures

1. Device tolerability [7 days]

   We will measure the number of patients that are compliant with the treatment and quantify their experience with a questionnaire.

Other Outcome Measures

1. Device Safety event rate [7 days]

   We will monitor for any device related adverse events - skin ulceration, DVT/PE, limb ischemia, etc.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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, items 6A and 6B)

6. Prescribed mechanical therapy for DVT prophylaxis.

Exclusion Criteria:

1. Inability or contraindication to applying IPC to both legs such as:

• Evidence of bone fracture in lower extremities

• Burns in the lower extremities, lacerations, ulcers, active skin infection or dermatitis,

• ischemic limb in the legs at the site of IPC placement

• Acute ischemia in the lower extremities

• Severe peripheral vascular disease

• Amputated foot or leg on one or two sides

• Compartment syndrome

• Severe lower extremity edema

• Acute deep vein thrombosis

1. Subjects who received tPA therapy for their stroke

2. Pregnancy or within 6 weeks of postpartum period

3. Limitation of life support, life expectancy < 7 days, or in hospice care

4. A head-unit is unavailable for the first 24 hours or more

5. 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

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19146

Sponsors and Collaborators

• OsciFlex LLC
• University of Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: OsciFlex LLC
• ClinicalTrials.gov Identifier: NCT05389488
• Other Study ID Numbers: OSC-VTE-003
• First Posted: May 25, 2022
• Last Update Posted: May 25, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Ischemic Stroke; Thrombosis; Venous Thrombosis

Study Results

No Results Posted as of May 25, 2022