OsciPulse D-dimer Efficacy Trial

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05389488
• Other study ID #: OSC-VTE-003
• Status: Withdrawn
• Phase: Phase 2
• Start date: December 2022
• Est. completion date: March 2023

Study information

• Verified date: November 2023
• Source: OsciFlex LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

2. Subjects who received tPA therapy for their stroke

3. 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 for the first 24 hours or more

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.

Related Conditions & MeSH terms

• Ischemic Stroke
• Thrombosis
• Venous Thromboses
• Venous Thrombosis

Intervention

Device:
• OsciPulse system
The OsciPulse system is a pneumatic compression system designed to provide intermittent compression to the limbs to augment venous blood flow.
• Flowtron ACS900
The Arjo Flowtron ACS900 intermittent pneumatic compression system provides compression the calf to augment venous blood flow.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
OsciFlex LLC	University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Device Safety event rate	We will monitor for any device related adverse events - skin ulceration, DVT/PE, limb ischemia, etc.	7 days
Primary	Relative change in serum d-dimer levels	We will measure the change in serum d-dimer levels over time as a marker of venous coagulation.	7 days
Secondary	Device tolerability	We will measure the number of patients that are compliant with the treatment and quantify their experience with a questionnaire.	7 days