Ignite Creation Date:
2024-07-17 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06477016
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-20
Brief Title:
OsciPulse D-dimer Pilot Trial
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
A Randomized Pilot Study of the Efficacy of the OsciPulse System for the Reduction of Serum D-dimer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
This is a single site randomized open label two arm study The patient population will be randomly divided into two arms with one receiving the OsciPulse System and the other receiving standard intermittent compression therapy
Both arms will have the therapy applied within 24 hours of admission and continue during their hospital stay until day 7 or discharge whichever is shorter unless clinically required to be removed Daily d-dimer levels will be assessed until day 7 or discharge If required beyond day 7 standard compression therapy will be provided An interim analysis will be performed after 20 subjects are enrolled to evaluate the speed of enrollment and data variability and quality If indicated enrollment will be increased up to 40
Both arms will have the therapy applied within 24 hours of admission and continue during their hospital stay until day 7 or discharge whichever is shorter unless clinically required to be removed Daily d-dimer levels will be assessed until day 7 or discharge If required beyond day 7 standard compression therapy will be provided An interim analysis will be performed after 20 subjects are enrolled to evaluate the speed of enrollment and data variability and quality If indicated enrollment will be increased up to 40
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None