Ischemic StrokeNCT03673241
Study of the Guardian System on Motor Recovery and Impact on Length of Stay in Ischemic Stroke Patients
A study testing Guardian System in people with Ischemic Stroke, run by TurnCare Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Guardian System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2018to 28 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Good Samaritan Hospital
San Jose, California, 95124
Fern Cudlip, MSN FNP CNRN NVRN FNCS, 408-724-0979, Fern.cudlip@hcahealthcare.com
About this study
Official title: A Randomized, Non-Blinded Clinical Trial of a Non-Invasive Perfusion Enhancement System (Guardian System) on Motor Recovery and Impact on Length of Stay in Mobility Impaired Ischemic Stroke Patients
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.
Read the detailed description
This clinical research study is a prospective, non-blinded randomized clinical trial. The study protocol and consent form have been approved by the IRB at the Study Institution. As per the study design, consecutive adult patients admitted to the neuro-intensive care unit, with acute ischemic stroke, meeting the inclusion and exclusion criteria will be consented and enrolled in the study. Both the Study and Control groups will receive the standard of care for ischemic stroke according to the hospitals' protocols, policies and procedures. After obtaining informed consent, patients in the study arm will have the non-invasive perfusion enhancement system (The Guardian System) placed on their beds and chairs. The inflatable surfaces (the enhancers) will be placed directly on the mattress and chair under the fitted sheet and bed linens. They will be secured with a non-porous, non-slip silicone attacher. An adaptive pressure controller will be attached to the perfusion enhancer through a connector set. The adaptive pressure controller will be secured to the bed foot board or side rail and have the ability to be secured to an Intravenous pole as necessary. Specific data points for each patient in the Experimental group will be entered into the Controller: they include the patient's weight in kilograms and the patient's position (bed or chair).
This study seeks to evaluate the device's effect on motor recovery and length of stay in a homogeneous ischemic stroke population that will be randomized for use of the novel non-invasive perfusion enhancement device from admission to discharge.
- Conditions
- Ischemic Stroke
- Being tested
- Guardian System
- Keywords
- Ischemic Stroke, Motor Recovery, Length of Stay Reduction
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Guardian System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The time frame will be up to and including 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start30 Oct 2018 (estimated)
- Primary completion30 Jan 2019 (estimated)
- Study completion28 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, non-blinded, randomized trial. This cohort will be divided into two groups: (1) The Control Group (2) The Study Group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TurnCare Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fern Cudlip, MSN FNP CNRN, Principal investigator, Good Samaritan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673241
- Sponsor's protocol ID
- 18-6235
- Status last verified
- Sep 2018
- First submitted
- 13 Sep 2018
- Last updated
- 17 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 19919699Bharucha 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.
PubMed 29889718Doll 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.
PubMed 25276489Davies 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.
PubMed 9886359Zheng Z, Yenari MA. Post-ischemic inflammation: molecular mechanisms and therapeutic implications. Neurol Res. 2004 Dec;26(8):884-92. doi: 10.1179/016164104X2357.
PubMed 15727272Nour M, Scalzo F, Liebeskind DS. Ischemia-reperfusion injury in stroke. Interv Neurol. 2013 Sep;1(3-4):185-99. doi: 10.1159/000353125.
PubMed 25187778Du 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.
PubMed 24839354Jiang 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.
PubMed 21350273Eltzschig HK, Eckle T. Ischemia and reperfusion--from mechanism to translation. Nat Med. 2011 Nov 7;17(11):1391-401. doi: 10.1038/nm.2507.
PubMed 22064429
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Non-Blinded Clinical Trial of a Non-Invasive Perfusion Enhancement System (Guardian System) on Motor Recovery and Impact on Length of Stay in Mobility Impaired Ischemic Stroke Patients
- ClinicalTrials.gov ID
- NCT03673241
- Acronym / sponsor ID
- 18-6235
- Conditions
- Ischemic Stroke
- Keywords
- Ischemic Stroke, Motor Recovery, Length of Stay Reduction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- TurnCare Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Oct 2018 (estimated)
- Primary completion
- 30 Jan 2019 (estimated)
- Study completion
- 28 Mar 2019 (estimated)
- First posted
- 17 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This clinical research study is a prospective, non-blinded randomized clinical trial. The study protocol and consent form have been approved by the IRB at the Study Institution. As per the study design, consecutive adult patients admitted to the neuro-intensive care unit, with acute ischemic stroke, meeting the inclusion and exclusion criteria will be consented and enrolled in the study. Both the Study and Control groups will receive the standard of care for ischemic stroke according to the hospitals' protocols, policies and procedures. After obtaining informed consent, patients in the study arm will have the non-invasive perfusion enhancement system (The Guardian System) placed on their beds and chairs. The inflatable surfaces (the enhancers) will be placed directly on the mattress and chair under the fitted sheet and bed linens. They will be secured with a non-porous, non-slip silicone attacher. An adaptive pressure controller will be attached to the perfusion enhancer through a connector set. The adaptive pressure controller will be secured to the bed foot board or side rail and have the ability to be secured to an Intravenous pole as necessary. Specific data points for each patient in the Experimental group will be entered into the Controller: they include the patient's weight in kilograms and the patient's position (bed or chair).
This study seeks to evaluate the device's effect on motor recovery and length of stay in a homogeneous ischemic stroke population that will be randomized for use of the novel non-invasive perfusion enhancement device from admission to discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective, non-blinded, randomized trial. This cohort will be divided into two groups: (1) The Control Group (2) The Study Group
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Guardian SystemThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guardian SystemThe 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 . | Device | Study Arm |
Primary outcome
Length of Stay Reduction in Acute Ischemic Stroke Patients in the Control and Study Arm Groups
Time frame: The time frame will be up to and including 24 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
- Background: PubMed 19919699Lakhan 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.
- Background: PubMed 29889718Bharucha 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.
- Background: PubMed 25276489Doll 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.
- Background: PubMed 9886359Davies 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.
- Background: PubMed 15727272Zheng Z, Yenari MA. Post-ischemic inflammation: molecular mechanisms and therapeutic implications. Neurol Res. 2004 Dec;26(8):884-92. doi: 10.1179/016164104X2357.
- Background: PubMed 25187778Nour M, Scalzo F, Liebeskind DS. Ischemia-reperfusion injury in stroke. Interv Neurol. 2013 Sep;1(3-4):185-99. doi: 10.1159/000353125.
- Background: PubMed 24839354Du 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.
- Background: PubMed 21350273Jiang 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.
- Background: PubMed 22064429Eltzschig HK, Eckle T. Ischemia and reperfusion--from mechanism to translation. Nat Med. 2011 Nov 7;17(11):1391-401. doi: 10.1038/nm.2507.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fern Cudlip, MSN FNP CNRN principal investigator
Good Samaritan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guardian System in people with Ischemic Stroke, run by TurnCare Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fern Cudlip, MSN FNP CNRN NVRN ANVP FNCS (408-724-0979, Fern.cudlip@hcahealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Stay Reduction in Acute Ischemic Stroke Patients in the Control and Study Arm Groups (time frame: The time frame will be up to and including 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03673241, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2018.