Back to resultsOsciPulse D-dimer Efficacy Trial
Primary Purpose
Venous Thromboses, Ischemic Stroke
Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
OsciPulse system
Flowtron ACS900
Sponsored by
About this trial
This is an interventional prevention trial for Venous Thromboses
Eligibility Criteria
Inclusion Criteria:
- Adult aged ≥ 18 years old
- Admitted to the Neuro Intensive Care Unit or Intermediate Neuro Care Unit with a diagnosis of ischemic stroke
- Last known normal < 24 hours.
- NIH stroke score ≥5
- Weakness in at least one leg (≥ 1 point on the NIHSS lower extremity motor scores, items 6A and 6B)
- Prescribed mechanical therapy for DVT prophylaxis.
Exclusion Criteria:
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
- Subjects who received tPA therapy for their stroke
- Pregnancy or within 6 weeks of postpartum period
- Limitation of life support, life expectancy < 7 days, or in hospice care
- A head-unit is unavailable for the first 24 hours or more
- 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.
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Arm
Study Arm
Arm Description
Subjects will receive standard of care intermittent compression therapy using the current devices used in the clinical space.
Subjects will receive compression therapy from the OsciPulse system.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Device tolerability
We will measure the number of patients that are compliant with the treatment and quantify their experience with a questionnaire.
Full Information
NCT ID
NCT05389488
First Posted
May 20, 2022
Last Updated
September 19, 2022
Sponsor
OsciFlex LLC
Collaborators
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT05389488
Brief Title
OsciPulse D-dimer Efficacy Trial
Official Title
A Randomized Pilot Study of the Efficacy of the OsciPulse System for the Reduction of Serum D-dimer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
March 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OsciFlex LLC
Collaborators
University of Pennsylvania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboses, Ischemic Stroke
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
Subjects will receive standard of care intermittent compression therapy using the current devices used in the clinical space.
Arm Title
Study Arm
Arm Type
Experimental
Arm Description
Subjects will receive compression therapy from the OsciPulse system.
Intervention Type
Device
Intervention Name(s)
OsciPulse system
Intervention Description
The OsciPulse system is a pneumatic compression system designed to provide intermittent compression to the limbs to augment venous blood flow.
Intervention Type
Device
Intervention Name(s)
Flowtron ACS900
Intervention Description
The Arjo Flowtron ACS900 intermittent pneumatic compression system provides compression the calf to augment venous blood flow.
Primary Outcome Measure Information:
Title
Relative change in serum d-dimer levels
Description
We will measure the change in serum d-dimer levels over time as a marker of venous coagulation.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Device tolerability
Description
We will measure the number of patients that are compliant with the treatment and quantify their experience with a questionnaire.
Time Frame
7 days
Other Pre-specified Outcome Measures:
Title
Device Safety event rate
Description
We will monitor for any device related adverse events - skin ulceration, DVT/PE, limb ischemia, etc.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult aged ≥ 18 years old
Admitted to the Neuro Intensive Care Unit or Intermediate Neuro Care Unit with a diagnosis of ischemic stroke
Last known normal < 24 hours.
NIH stroke score ≥5
Weakness in at least one leg (≥ 1 point on the NIHSS lower extremity motor scores, items 6A and 6B)
Prescribed mechanical therapy for DVT prophylaxis.
Exclusion Criteria:
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
Subjects who received tPA therapy for their stroke
Pregnancy or within 6 weeks of postpartum period
Limitation of life support, life expectancy < 7 days, or in hospice care
A head-unit is unavailable for the first 24 hours or more
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.
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eileen M Maloney-Wilensky, ACNP, MSN
Phone
215-662-6462
Email
Eileen.Maloney@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Leah Coghlan, BSN, RN
Phone
215-615-5436
Email
Leah.Coghlan@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Steven R Messe, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
The data will be available following publication of the study results. The data will be available for 24 months.
IPD Sharing Access Criteria
The data will be available to university or non-profit researchers.
Learn more about this trial
OsciPulse D-dimer Efficacy Trial
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