NCT03673241

Brief Summary

This is a non-blinded randomized study that will investigate whether the use of a novel, non-invasive perfusion enhancement system (The Guardian System) impacts motor recovery and hospital length of stay in acute ischemic stroke patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 17, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

October 30, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2019

Completed
Last Updated

September 17, 2018

Status Verified

September 1, 2018

Enrollment Period

3 months

First QC Date

September 13, 2018

Last Update Submit

September 13, 2018

Conditions

Ischemic Stroke

Keywords

Ischemic StrokeMotor RecoveryLength of Stay Reduction

Outcome Measures

Primary Outcomes (1)

  • Length of Stay Reduction in Acute Ischemic Stroke Patients in the Control and Study Arm Groups

    The length of stay of acute ischemic stroke patients measured from the time of randomization until the the date of discharge or date of death from any cause, whichever came first.

    The time frame will be up to and including 24 months

Study Arms (2)

Control Group

NO INTERVENTION

The Control Group will receive the standard support surface mattresses/bed surfaces and recovery chairs without the non-invasive perfusion enhancement system (The Guardian System)

Study Arm

EXPERIMENTAL

The Study Arm will have the non-invasive perfusion enhancement system placed on their beds and recovery chairs. Patients will be utilizing the systems while lying in bed or sitting in the chair.

Device: Guardian System

Interventions

Guardian SystemDEVICE

The Study arm will have the Guardian system applied to their bed and recovery chair with the intent for the patient to have the inflatable surface utilized underneath them .

Study Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Only Acute Ischemic Stroke Patients
  • Baseline Modified Rankin Score of less than or equal to 0-2
  • Remains hemiplegic (left or right) with motor component score on National Institute of Stroke Health Scale of 2-4 on arm/leg with or without thrombectomy/tissue plasminogen activator
  • Insured (Medicare or private)

You may not qualify if:

  • Dementia or Alzheimer Diagnosis
  • Concurrent hemodialysis
  • Obesity with Body Mass Index greater than 33
  • Baseline Modified Rankin Score of 3 to 5
  • Patients requiring ventilator support of greater than 2 days
  • Peripheral neuropathy
  • Concurrent deep vein thrombosis or venous thromboembolism
  • Presence of concurrent pre-existing pressure injury
  • Prolonged inconsistent use of perfusion therapy defined as two or more consecutive hours off of the perfusion enhancement device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Good Samaritan Hospital

San Jose, California, 95124, United States

Location

Related Publications (9)

  • Lakhan SE, Kirchgessner A, Hofer M. Inflammatory mechanisms in ischemic stroke: therapeutic approaches. J Transl Med. 2009 Nov 17;7:97. doi: 10.1186/1479-5876-7-97.

    PMID: 19919699BACKGROUND

  • Bharucha JB, Seaman L, Powers M, Kelly E, Seaman R, Forcier L, McGinnis J, Nodiff I, Pawlak B, Snyder S, Nodiff S, Patel R, Squitieri R, Wang L. A Prospective Randomized Clinical Trial of a Novel, Noninvasive Perfusion Enhancement System for the Prevention of Hospital-Acquired Sacral Pressure Injuries. J Wound Ostomy Continence Nurs. 2018 Jul/Aug;45(4):310-318. doi: 10.1097/WON.0000000000000450.

    PMID: 29889718BACKGROUND

  • Doll DN, Barr TL, Simpkins JW. Cytokines: their role in stroke and potential use as biomarkers and therapeutic targets. Aging Dis. 2014 Oct 1;5(5):294-306. doi: 10.14336/AD.2014.0500294. eCollection 2014 Oct.

    PMID: 25276489BACKGROUND

  • Davies CA, Loddick SA, Toulmond S, Stroemer RP, Hunt J, Rothwell NJ. The progression and topographic distribution of interleukin-1beta expression after permanent middle cerebral artery occlusion in the rat. J Cereb Blood Flow Metab. 1999 Jan;19(1):87-98. doi: 10.1097/00004647-199901000-00010.

    PMID: 9886359BACKGROUND

  • Zheng Z, Yenari MA. Post-ischemic inflammation: molecular mechanisms and therapeutic implications. Neurol Res. 2004 Dec;26(8):884-92. doi: 10.1179/016164104X2357.

    PMID: 15727272BACKGROUND

  • Nour M, Scalzo F, Liebeskind DS. Ischemia-reperfusion injury in stroke. Interv Neurol. 2013 Sep;1(3-4):185-99. doi: 10.1159/000353125.

    PMID: 25187778BACKGROUND

  • Du T, Zhu YJ. The regulation of inflammatory mediators in acute kidney injury via exogenous mesenchymal stem cells. Mediators Inflamm. 2014;2014:261697. doi: 10.1155/2014/261697. Epub 2014 Apr 15.

    PMID: 24839354BACKGROUND

  • Jiang LP, Tu Q, Wang Y, Zhang E. Ischemia-reperfusion injury-induced histological changes affecting early stage pressure ulcer development in a rat model. Ostomy Wound Manage. 2011 Feb;57(2):55-60.

    PMID: 21350273BACKGROUND

  • Eltzschig HK, Eckle T. Ischemia and reperfusion--from mechanism to translation. Nat Med. 2011 Nov 7;17(11):1391-401. doi: 10.1038/nm.2507.

    PMID: 22064429BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Fern Cudlip, MSN FNP CNRN

    Good Samaritan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fern Cudlip, MSN FNP CNRN NVRN ANVP FNCS

CONTACT

408-724-0979Fern.cudlip@hcahealthcare.com

Linda Seaman, MSN BSN RN CCRN

CONTACT

203-414-3173lseaman@turncare.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A prospective, non-blinded, randomized trial. This cohort will be divided into two groups: (1) The Control Group (2) The Study Group
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2018

First Posted

September 17, 2018

Study Start

October 30, 2018

Primary Completion

January 30, 2019

Study Completion

March 28, 2019

Last Updated

September 17, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)