OsciPulse D-dimer Efficacy Trial

NCT ID: NCT05389488

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-31
• Study Completion Date: 2023-03-31

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.

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.

Conditions

Venous Thromboses; Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control Arm

Subjects will receive standard of care intermittent compression therapy using the current devices used in the clinical space.

Group Type: ACTIVE_COMPARATOR

Flowtron ACS900

Intervention Type: DEVICE

The Arjo Flowtron ACS900 intermittent pneumatic compression system provides compression the calf to augment venous blood flow.

Study Arm

Subjects will receive compression therapy from the OsciPulse system.

Group Type: EXPERIMENTAL

OsciPulse system

Intervention Type: DEVICE

The OsciPulse system is a pneumatic compression system designed to provide intermittent compression to the limbs to augment venous blood flow.

Interventions

OsciPulse system

The OsciPulse system is a pneumatic compression system designed to provide intermittent compression to the limbs to augment venous blood flow.

Intervention Type: DEVICE

Flowtron ACS900

The Arjo Flowtron ACS900 intermittent pneumatic compression system provides compression the calf to augment venous blood flow.

Intervention Type: DEVICE

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, 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: collaborator

OsciFlex LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

OSC-VTE-003

Identifier Type: -

Identifier Source: org_study_id