Acute StrokeE-NESENCT03621917
Evaluation of the Effectiveness of Thrombolytic Therapy in Acute Ischemic Stroke Patients Using NIRS
An observational study of Acute Stroke and Thrombolytic Therapy, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
Investigators aim to study effectiveness of systemic thrombolytic therapy on acute ischemic stroke patients with near infrared spectroscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke, Thrombolytic Therapy, Stroke, Ischemic
- What is being tested?
- Near-infrared spectroscopy reading
- Type of treatment
- Medical device
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2017to 1 Oct 2018
- Phase
- Observational
- 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
Study population: Any patient admited who are over 18 years old and having treated with thrombolytic due to acute ischemic stroke at Dokuz Eylul University Hospital Izmir/Turkey during one year period (15/11/2017 - 15/11/2018)
Who may be able to join
- Any patient presented to emergency deparment with acute stroke who undergoes thrombolytic therapy
- Patients with age over 18 years old
Who cannot join
- Not accepting to be included to study (including during study)
- Patients who NIRS monitoring cannot be performed for any reason (device being occupied, the absence of a practicing team, etc.)
- Patients with (hematoma, mass etc.) skin lesions in the forehead region (electrode placement site)
- Patients with jaundice on skin (which can interfere with device readings)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dokuz Eylul University Hospital
Izmir, Narlidere, 35320
About this study
Official title: Evaluation of the Effectiveness of Thrombolytic Therapy in Acute Ischemic Stroke Patients Using Near-Infrared Spectroscopy
Investigators aim to study effectiveness of systemic thrombolytic therapy on acute ischemic stroke patients with near infrared spectroscopy.
Read the detailed description
Acute ischemic stroke is characterized by cerebral vascular occlusion. Early thrombolytic therapy is an important way of treatment for these set of individuals. This condition is a serious cause of mortality and morbidity among the individuals who present to emergency department. Recombinant tissue plasminogen activator (rtPA) is the only proven treatment method in individuals with acute ischemic stroke in the first three hours. License for the use of intravenous rtPA in acute ischemic stroke in Turkey was given in 2006. Since then, no data of this drug has been submitted except for a few reports and papers.
In this study, investigators planned to evaluate the efficacy of rTPA treatment by evaluating cerebral perfusion; before, during and after in participants who will be treated with thrombolytic therapy. The evaluation will be done by using NIRS (Near-Infrared Spectroscopy) by means of non-invasively placed electrodes with readings of cerebral saturation measurement.
Individuals with acute ischemic stroke has being evaluated with NIHSS (National Institutes of Health Stroke Scale) and if appropriate, thrombolytic treatment decision is taken.Participants of this study will be selected from individuals who applied to Dokuz Eylül University Emergency Department due to acute ischemic stroke in one year period. These participants will be monitored noninvasively for routine cardiac and respiratory follow-up.
After informed voluntary consent form is signed, a non-invasive NIRS monitorization will be started due to readings from participants' forehead region. NIRS readings are harmless and does not interfere with the treatment therefore it is not possible to make any negative contribution to the treatment process via this study.
In this study, NIRS measurement results, follow-up parameters and participants' neurological status will be investigated. Participants to be treated with routine emergency thrombolytic therapy will be invastigated with near infrared spectroscopy. Routine scheduled treatment will not be intercepted or changed. The drugs to be used will be determined by the emergency department and neurology physician dealing with the participants' condition and not to be interfered by this study.
The medication and doses that the participants are scheduled to be administered by his / her physician will not be intervened in the manner and timing of the operation that requires it.
Because of the NIRS measurement is done with a simple electrode placed on forehead there will be no adverse effects on the examination nor treatment and it cannot interfere with routine approach of these therapy. In our study participants' vital parameters (blood pressure, heart rate, respiratory rate, sat O2), glasgow coma scale, NIRS values and NIHSS will be recorded during thrombolytic therapy at every 15 minutes (0.min, 15.min, 30min, 45min, 60min) and at 120 minutes. Furthermore NIRS values and imaging results will be recorded for investigation. In addition, if complications that may arise secondary to this treatment the complications' time and type will be obtained.
The obtained data will be recorded to and the results will be evaluated.
- Conditions
- Acute Stroke, Thrombolytic Therapy, Stroke, Ischemic
- Being tested
- Near-infrared spectroscopy reading
- Keywords
- near infrared spectroscopy, acute ischemic stroke, thrombolytic therapy
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-infrared spectroscopy readingDevice
Non-invasive readings will be taken from forehead with near-infrared spectroscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous Near Infrared Spectroscopy reading during thrombolytic therapy
Patients who are undergoing thrombolytic medication (which takes 1 hour) will be Monitored with NIRS device and neurological findings and device readings will be investigated afterwards, to show/if clinical changes are correlated with readings
Measured: 120 minutes
Secondary outcomes (1)
Assesment of complications with NIRS
if any complications of thrombolytic therapy occurs during treatment, time and type of those complications and NIRS readings of that time will be recorded to see if there is any correlation
Measured: During thrombolytic treatment (60 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start1 Nov 2017
- Primary completion1 Oct 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Emre Sanci, Dokuz Eylul University
- Investigators
- Nese Colak Oray, MD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621917
- Sponsor's protocol ID
- 405-SBKAEK
- Other IDs
- 2018.KB.SAG.062
- Acronym
- E-NESE
- Status last verified
- Oct 2018
- First submitted
- 4 Aug 2018
- Last updated
- 26 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Thrombolytic Therapy in Acute Ischemic Stroke Patients Using Near-Infrared Spectroscopy
- ClinicalTrials.gov ID
- NCT03621917
- Acronym / sponsor ID
- E-NESE / 405-SBKAEK
- Conditions
- Acute Stroke, Thrombolytic Therapy, Stroke, Ischemic
- Keywords
- near infrared spectroscopy, acute ischemic stroke, thrombolytic therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 9 Aug 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.
Investigators aim to study effectiveness of systemic thrombolytic therapy on acute ischemic stroke patients with near infrared spectroscopy.
Detailed description
Acute ischemic stroke is characterized by cerebral vascular occlusion. Early thrombolytic therapy is an important way of treatment for these set of individuals. This condition is a serious cause of mortality and morbidity among the individuals who present to emergency department. Recombinant tissue plasminogen activator (rtPA) is the only proven treatment method in individuals with acute ischemic stroke in the first three hours. License for the use of intravenous rtPA in acute ischemic stroke in Turkey was given in 2006. Since then, no data of this drug has been submitted except for a few reports and papers.
In this study, investigators planned to evaluate the efficacy of rTPA treatment by evaluating cerebral perfusion; before, during and after in participants who will be treated with thrombolytic therapy. The evaluation will be done by using NIRS (Near-Infrared Spectroscopy) by means of non-invasively placed electrodes with readings of cerebral saturation measurement.
Individuals with acute ischemic stroke has being evaluated with NIHSS (National Institutes of Health Stroke Scale) and if appropriate, thrombolytic treatment decision is taken.Participants of this study will be selected from individuals who applied to Dokuz Eylül University Emergency Department due to acute ischemic stroke in one year period. These participants will be monitored noninvasively for routine cardiac and respiratory follow-up.
After informed voluntary consent form is signed, a non-invasive NIRS monitorization will be started due to readings from participants' forehead region. NIRS readings are harmless and does not interfere with the treatment therefore it is not possible to make any negative contribution to the treatment process via this study.
In this study, NIRS measurement results, follow-up parameters and participants' neurological status will be investigated. Participants to be treated with routine emergency thrombolytic therapy will be invastigated with near infrared spectroscopy. Routine scheduled treatment will not be intercepted or changed. The drugs to be used will be determined by the emergency department and neurology physician dealing with the participants' condition and not to be interfered by this study.
The medication and doses that the participants are scheduled to be administered by his / her physician will not be intervened in the manner and timing of the operation that requires it.
Because of the NIRS measurement is done with a simple electrode placed on forehead there will be no adverse effects on the examination nor treatment and it cannot interfere with routine approach of these therapy. In our study participants' vital parameters (blood pressure, heart rate, respiratory rate, sat O2), glasgow coma scale, NIRS values and NIHSS will be recorded during thrombolytic therapy at every 15 minutes (0.min, 15.min, 30min, 45min, 60min) and at 120 minutes. Furthermore NIRS values and imaging results will be recorded for investigation. In addition, if complications that may arise secondary to this treatment the complications' time and type will be obtained.
The obtained data will be recorded to and the results will be evaluated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient admited who are over 18 years old and having treated with thrombolytic due to acute ischemic stroke at Dokuz Eylul University Hospital Izmir/Turkey during one year period (15/11/2017 - 15/11/2018)
Key inclusion criteria (2 listed)
- Any patient presented to emergency deparment with acute stroke who undergoes thrombolytic therapy
- Patients with age over 18 years old
Key exclusion criteria (4 listed)
- Not accepting to be included to study (including during study)
- Patients who NIRS monitoring cannot be performed for any reason (device being occupied, the absence of a practicing team, etc.)
- Patients with (hematoma, mass etc.) skin lesions in the forehead region (electrode placement site)
- Patients with jaundice on skin (which can interfere with device readings)
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 |
|---|---|---|
| Near-infrared spectroscopy readingNon-invasive readings will be taken from forehead with near-infrared spectroscopy | Device | – |
Primary outcome
Continuous Near Infrared Spectroscopy reading during thrombolytic therapy
Time frame: 120 minutes
Patients who are undergoing thrombolytic medication (which takes 1 hour) will be Monitored with NIRS device and neurological findings and device readings will be investigated afterwards, to show/if clinical changes are correlated with readings
1 secondary outcome
Assesment of complications with NIRS
Time frame: During thrombolytic treatment (60 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
- Individual participant dataSharing planned: Undecided
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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.
Nese Colak Oray, MD study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Stroke and Thrombolytic Therapy, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 26 Oct 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous Near Infrared Spectroscopy reading during thrombolytic therapy (time frame: 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2018.