Extracorporeal Membrane Oxygenation ComplicationSAFE MRINCT05469139
Assessing Brain Injury Using Portable Magnetic Resonance Imaging (MRI)
An observational study of Extracorporeal Membrane Oxygenation Complication and Acute Brain Injury, run by Johns Hopkins University at 2 sites in United States.
Trial summary
This study aims to assess the feasibility of assessing acute brain injury using a portable low field MRI in patients on ECMO. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extracorporeal Membrane Oxygenation Complication, Acute Brain Injury
- What is being tested?
- Portable MRI acquisition
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Dec 2021to 11 Mar 2024
- 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: Adults patients on extracorporeal membrane oxygenation support (ECMO)
Who may be able to join
- Adults age 18 and over
- Patient supported with extracorporeal membrane oxygenation support (ECMO)
- Legally authorized representative has provided written informed consent
Who cannot join
- Patient has a contraindication for MRI such as:
- Implants such as pacemaker, defibrillator, implanted insulin pump, deep brain stimulator, vagus nerve stimulator, cochlear implant, or programmable shunt
- MRI incompatible surgical hardware such as staples, screws. ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, cochlear implant
- artificial hearts or heart valves with steel parts
- metal fragments
- shrapnel
Show all 13Show fewer
- tattoos near the eye
- permanent make-up
- steel implants
- or other irremovable ferromagnetic objects
- Patient weight is over 440 lbs (or 200kg)
- Patient has Intra Aortic Balloon Pump (IABP), Implanted Ventricular Assist Device (VAD), or Percutaneous Ventricular Assist Device
- Patient is pregnant
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
University of Texas Health Science Center
Houston, Texas, 77030
About this study
Official title: Assessing Brain Injury Using Portable Magnetic Resonance Imaging in Patients With Extracorporeal Membrane Oxygenation
This study aims to assess the feasibility of assessing acute brain injury using a portable low field MRI in patients on ECMO.
Read the detailed description
Extracorporeal membrane oxygenation (ECMO) is a life-saving therapy increasingly used in patients with refractory cardiopulmonary failure. The Extracorporeal Life Support Organization (ELSO) registry recently reported a 58% survival rate among patients who receive ECMO support, showing a significant mortality benefit in patients who would have not survived without ECMO. However, acute brain injury (ABI) is common in patients with ECMO support and leads to devastating consequences with significant morbidity and mortality. The mortality increases more than two-fold when ABI is present for both venoarterial (VA) and venovenous (VV) ECMO patients. The poor prognosis of ABI and neurological complications would suggest potential benefit from stringent and possibly even protocolized neurological monitoring to prevent or minimize further harm. This is particularly important as recent evidence promotes extracorporeal cardiopulmonary resuscitation (ECPR) as a rescue therapy for patients suffering from cardiac arrest of potentially reversible etiology. As clinical experience accumulates and ECPR becomes more widely used, neurological monitoring for complications and prognostication will be imperative for optimizing patient outcomes.
Although standardized neurological monitoring improves the detection of ABI, timely diagnosis and management for ABI in patients with ECMO support is still challenging due to the difficulty, impracticality, and danger of transporting ECMO patients to a CT scanner. Often, ECMO patients are unable to be transported to radiology suites because of the patients' persistent cardiopulmonary instability with multiple vasopressor requirements. In addition, even if head CT is performed in these patients, it is limited by poor sensitivity for detecting acute ischemic brain injury. Early neuroimaging is a key neuromonitoring aspect in the clinical evaluation of ABI. However, conventional magnetic resonance imaging (MRI) systems operate at high magnetic field strengths (1.5-3T) that require strict, access-controlled environments. Thus, limited access to timely brain scan with images of sufficient quality remains a significant barrier to effectively monitoring the occurrence and progression of ABI in ECMO.
Recent advances in low-field and portable MRI technology have enabled the acquisition of clinically meaningful imaging in the presence of ferromagnetic materials. A very low magnetic field strength, 64 magnetization transfer (mT), approximately 1/23 the field strength of a conventional MRI) provides a 5 Gauss line (safety zone) that is only about 2.5 feet from the center of the scanner. In a previous report, researchers were able to demonstrate the feasibility of a low-field, portable MRI in complex clinical care settings, such as intensive care units, without any adverse events or complications. In addition to reduced projectile motion, the use of low-field MRI may mitigate other safety concerns associated with high-field MRI, such as peripheral nerve stimulation (from gradients), a radiofrequency absorption and heating and acoustic noise.
The objective of this study is to assess acute brain injury with low-field, portable MRI of brain in patients with ECMO support.
This study will use the Hyperfine portable MRI machine which has FDA 510(k) clearance and is intended for use in intensive care units. The investigators' hypothesis is that low-field, portable MRI can detect ABI in patients with ECMO support, which may decrease the morbidity of patients on ECMO.
- Being tested
- Portable MRI acquisition
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portable MRI acquisitionDiagnostic test
Patients on ECMO will undergo a portable MRI of the brain
| Study group | Role | What they receive |
|---|---|---|
| Portable MRI group | Patients on ECMO who undergo portable MRI to assess brain injury within 24-48 hours of ECMO initiation Receives: Diagnostic Test: Portable MRI acquisition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute brain injury as assessed by head CT scan
compare results of routinely performed head CT scans with results from a low field MRI to determine whether acute brain injury can be assessed using a low field MRI in patients with ECMO support.
Measured: 48 hours from ECMO initiation
Secondary outcomes (4)
prevalence of early acute brain injury as assessed by MRI scan
use interpretations of low field MRI scans to determine the prevalence of early acute brain injury of patients with ECMO support at 24 hours
Measured: 24 hours from ECMO initiation
Image Quality
compare image quality of low field MRI scans with the image quality of routinely performed head CT scans to assess the image quality of MR images for infarcts and hemorrhages
Measured: 48 hours from ECMO initiation
Impact of early detection as assessed by MRI
assess anticoagulation strategies following low field MRI to determine the impact of early detection of acute brain injury on anticoagulation strategy
Measured: 48 hours from ECMO initiation
Association of Transcranial doppler ultrasound with ischemic infarct
measure transcranial doppler ultrasounds and correlate the findings with the results of low field MRI to assess for an association between Transcranial doppler ultrasound (TCD) microembolic signal (MES) and the presence of ischemic infarct on MRI.
Measured: 48 hours from ECMO initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start10 Dec 2021
- Primary completion30 Nov 2023
- Study completion11 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Extracorporeal Membrane Oxygenation ComplicationStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Hyperfine
- Responsible party
- Sponsor
- Investigators
- Sung Min Cho, DO, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05469139
- Sponsor's protocol ID
- IRB00285716
- Acronym
- SAFE MRI
- Status last verified
- Mar 2024
- First submitted
- 19 Jul 2022
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Clinical Study report will be available upon completion of the study analysis
Publications
McCarthy FH, McDermott KM, Kini V, Gutsche JT, Wald JW, Xie D, Szeto WY, Bermudez CA, Atluri P, Acker MA, Desai ND. Trends in U.S. Extracorporeal Membrane Oxygenation Use and Outcomes: 2002-2012. Semin Thorac Cardiovasc Surg. 2015 Summer;27(2):81-8. doi: 10.1053/j.semtcvs.2015.07.005. Epub 2015 Jul 22.
PubMed 26686427Thiagarajan RR, Barbaro RP, Rycus PT, Mcmullan DM, Conrad SA, Fortenberry JD, Paden ML; ELSO member centers. Extracorporeal Life Support Organization Registry International Report 2016. ASAIO J. 2017 Jan/Feb;63(1):60-67. doi: 10.1097/MAT.0000000000000475.
PubMed 27984321Cho SM, Canner J, Caturegli G, Choi CW, Etchill E, Giuliano K, Chiarini G, Calligy K, Rycus P, Lorusso R, Kim BS, Sussman M, Suarez JI, Geocadin R, Bush EL, Ziai W, Whitman G. Risk Factors of Ischemic and Hemorrhagic Strokes During Venovenous Extracorporeal Membrane Oxygenation: Analysis of Data From the Extracorporeal Life Support Organization Registry. Crit Care Med. 2021 Jan 1;49(1):91-101. doi: 10.1097/CCM.0000000000004707.
PubMed 33148951Cho SM, Canner J, Chiarini G, Calligy K, Caturegli G, Rycus P, Barbaro RP, Tonna J, Lorusso R, Kilic A, Choi CW, Ziai W, Geocadin R, Whitman G. Modifiable Risk Factors and Mortality From Ischemic and Hemorrhagic Strokes in Patients Receiving Venoarterial Extracorporeal Membrane Oxygenation: Results From the Extracorporeal Life Support Organization Registry. Crit Care Med. 2020 Oct;48(10):e897-e905. doi: 10.1097/CCM.0000000000004498.
PubMed 32931195Brooks SC, Anderson ML, Bruder E, Daya MR, Gaffney A, Otto CW, Singer AJ, Thiagarajan RR, Travers AH. Part 6: Alternative Techniques and Ancillary Devices for Cardiopulmonary Resuscitation: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S436-43. doi: 10.1161/CIR.0000000000000260. No abstract available.
PubMed 26472994Cho SM, Ziai W, Mayasi Y, Gusdon AM, Creed J, Sharrock M, Stephens RS, Choi CW, Ritzl EK, Suarez J, Whitman G, Geocadin RG. Noninvasive Neurological Monitoring in Extracorporeal Membrane Oxygenation. ASAIO J. 2020 Apr;66(4):388-393. doi: 10.1097/MAT.0000000000001013.
PubMed 31045914Sheth KN, Mazurek MH, Yuen MM, Cahn BA, Shah JT, Ward A, Kim JA, Gilmore EJ, Falcone GJ, Petersen N, Gobeske KT, Kaddouh F, Hwang DY, Schindler J, Sansing L, Matouk C, Rothberg J, Sze G, Siner J, Rosen MS, Spudich S, Kimberly WT. Assessment of Brain Injury Using Portable, Low-Field Magnetic Resonance Imaging at the Bedside of Critically Ill Patients. JAMA Neurol. 2020 Sep 8;78(1):41-7. doi: 10.1001/jamaneurol.2020.3263. Online ahead of print.
PubMed 32897296Campbell-Washburn AE, Ramasawmy R, Restivo MC, Bhattacharya I, Basar B, Herzka DA, Hansen MS, Rogers T, Bandettini WP, McGuirt DR, Mancini C, Grodzki D, Schneider R, Majeed W, Bhat H, Xue H, Moss J, Malayeri AA, Jones EC, Koretsky AP, Kellman P, Chen MY, Lederman RJ, Balaban RS. Opportunities in Interventional and Diagnostic Imaging by Using High-Performance Low-Field-Strength MRI. Radiology. 2019 Nov;293(2):384-393. doi: 10.1148/radiol.2019190452. Epub 2019 Oct 1.
PubMed 31573398Formica D, Silvestri S. Biological effects of exposure to magnetic resonance imaging: an overview. Biomed Eng Online. 2004 Apr 22;3:11. doi: 10.1186/1475-925X-3-11.
PubMed 15104797Hartwig V, Giovannetti G, Vanello N, Lombardi M, Landini L, Simi S. Biological effects and safety in magnetic resonance imaging: a review. Int J Environ Res Public Health. 2009 Jun;6(6):1778-98. doi: 10.3390/ijerph6061778. Epub 2009 Jun 10.
PubMed 19578460Shellock FG, Crues JV. Aneurysm clips: assessment of magnetic field interaction associated with a 0.2-T extremity MR system. Radiology. 1998 Aug;208(2):407-9. doi: 10.1148/radiology.208.2.9680568.
PubMed 9680568Alorainy IA, Albadr FB, Abujamea AH. Attitude towards MRI safety during pregnancy. Ann Saudi Med. 2006 Jul-Aug;26(4):306-9. doi: 10.5144/0256-4947.2006.306. No abstract available.
PubMed 16885635
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Brain Injury Using Portable Magnetic Resonance Imaging in Patients With Extracorporeal Membrane Oxygenation
- ClinicalTrials.gov ID
- NCT05469139
- Acronym / sponsor ID
- SAFE MRI / IRB00285716
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Hyperfine
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 11 Mar 2024 (actual)
- First posted
- 21 Jul 2022 (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 study aims to assess the feasibility of assessing acute brain injury using a portable low field MRI in patients on ECMO.
Detailed description
Extracorporeal membrane oxygenation (ECMO) is a life-saving therapy increasingly used in patients with refractory cardiopulmonary failure. The Extracorporeal Life Support Organization (ELSO) registry recently reported a 58% survival rate among patients who receive ECMO support, showing a significant mortality benefit in patients who would have not survived without ECMO. However, acute brain injury (ABI) is common in patients with ECMO support and leads to devastating consequences with significant morbidity and mortality. The mortality increases more than two-fold when ABI is present for both venoarterial (VA) and venovenous (VV) ECMO patients. The poor prognosis of ABI and neurological complications would suggest potential benefit from stringent and possibly even protocolized neurological monitoring to prevent or minimize further harm. This is particularly important as recent evidence promotes extracorporeal cardiopulmonary resuscitation (ECPR) as a rescue therapy for patients suffering from cardiac arrest of potentially reversible etiology. As clinical experience accumulates and ECPR becomes more widely used, neurological monitoring for complications and prognostication will be imperative for optimizing patient outcomes.
Although standardized neurological monitoring improves the detection of ABI, timely diagnosis and management for ABI in patients with ECMO support is still challenging due to the difficulty, impracticality, and danger of transporting ECMO patients to a CT scanner. Often, ECMO patients are unable to be transported to radiology suites because of the patients' persistent cardiopulmonary instability with multiple vasopressor requirements. In addition, even if head CT is performed in these patients, it is limited by poor sensitivity for detecting acute ischemic brain injury. Early neuroimaging is a key neuromonitoring aspect in the clinical evaluation of ABI. However, conventional magnetic resonance imaging (MRI) systems operate at high magnetic field strengths (1.5-3T) that require strict, access-controlled environments. Thus, limited access to timely brain scan with images of sufficient quality remains a significant barrier to effectively monitoring the occurrence and progression of ABI in ECMO.
Recent advances in low-field and portable MRI technology have enabled the acquisition of clinically meaningful imaging in the presence of ferromagnetic materials. A very low magnetic field strength, 64 magnetization transfer (mT), approximately 1/23 the field strength of a conventional MRI) provides a 5 Gauss line (safety zone) that is only about 2.5 feet from the center of the scanner. In a previous report, researchers were able to demonstrate the feasibility of a low-field, portable MRI in complex clinical care settings, such as intensive care units, without any adverse events or complications. In addition to reduced projectile motion, the use of low-field MRI may mitigate other safety concerns associated with high-field MRI, such as peripheral nerve stimulation (from gradients), a radiofrequency absorption and heating and acoustic noise.
The objective of this study is to assess acute brain injury with low-field, portable MRI of brain in patients with ECMO support.
This study will use the Hyperfine portable MRI machine which has FDA 510(k) clearance and is intended for use in intensive care units. The investigators' hypothesis is that low-field, portable MRI can detect ABI in patients with ECMO support, which may decrease the morbidity of patients on ECMO.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Portable MRI group | – | Diagnostic Test: Portable MRI acquisitionPatients on ECMO who undergo portable MRI to assess brain injury within 24-48 hours of ECMO initiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults patients on extracorporeal membrane oxygenation support (ECMO)
Key inclusion criteria (3 listed)
- Adults age 18 and over
- Patient supported with extracorporeal membrane oxygenation support (ECMO)
- Legally authorized representative has provided written informed consent
Key exclusion criteria (13 listed)
- Patient has a contraindication for MRI such as:
- Implants such as pacemaker, defibrillator, implanted insulin pump, deep brain stimulator, vagus nerve stimulator, cochlear implant, or programmable shunt
- MRI incompatible surgical hardware such as staples, screws. ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, cochlear implant
- artificial hearts or heart valves with steel parts
- metal fragments
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 |
|---|---|---|
| Portable MRI acquisitionPatients on ECMO will undergo a portable MRI of the brain | Diagnostic test | Portable MRI group |
Primary outcome
Acute brain injury as assessed by head CT scan
Time frame: 48 hours from ECMO initiation
compare results of routinely performed head CT scans with results from a low field MRI to determine whether acute brain injury can be assessed using a low field MRI in patients with ECMO support.
4 secondary outcomes
prevalence of early acute brain injury as assessed by MRI scan
Time frame: 24 hours from ECMO initiation
Image Quality
Time frame: 48 hours from ECMO initiation
Impact of early detection as assessed by MRI
Time frame: 48 hours from ECMO initiation
Association of Transcranial doppler ultrasound with ischemic infarct
Time frame: 48 hours from ECMO initiation
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 13 Mar 2024.
- Background: PubMed 26686427McCarthy FH, McDermott KM, Kini V, Gutsche JT, Wald JW, Xie D, Szeto WY, Bermudez CA, Atluri P, Acker MA, Desai ND. Trends in U.S. Extracorporeal Membrane Oxygenation Use and Outcomes: 2002-2012. Semin Thorac Cardiovasc Surg. 2015 Summer;27(2):81-8. doi: 10.1053/j.semtcvs.2015.07.005. Epub 2015 Jul 22.
- Background: PubMed 27984321Thiagarajan RR, Barbaro RP, Rycus PT, Mcmullan DM, Conrad SA, Fortenberry JD, Paden ML; ELSO member centers. Extracorporeal Life Support Organization Registry International Report 2016. ASAIO J. 2017 Jan/Feb;63(1):60-67. doi: 10.1097/MAT.0000000000000475.
- Background: PubMed 33148951Cho SM, Canner J, Caturegli G, Choi CW, Etchill E, Giuliano K, Chiarini G, Calligy K, Rycus P, Lorusso R, Kim BS, Sussman M, Suarez JI, Geocadin R, Bush EL, Ziai W, Whitman G. Risk Factors of Ischemic and Hemorrhagic Strokes During Venovenous Extracorporeal Membrane Oxygenation: Analysis of Data From the Extracorporeal Life Support Organization Registry. Crit Care Med. 2021 Jan 1;49(1):91-101. doi: 10.1097/CCM.0000000000004707.
- Background: PubMed 32931195Cho SM, Canner J, Chiarini G, Calligy K, Caturegli G, Rycus P, Barbaro RP, Tonna J, Lorusso R, Kilic A, Choi CW, Ziai W, Geocadin R, Whitman G. Modifiable Risk Factors and Mortality From Ischemic and Hemorrhagic Strokes in Patients Receiving Venoarterial Extracorporeal Membrane Oxygenation: Results From the Extracorporeal Life Support Organization Registry. Crit Care Med. 2020 Oct;48(10):e897-e905. doi: 10.1097/CCM.0000000000004498.
- Background: PubMed 26472994Brooks SC, Anderson ML, Bruder E, Daya MR, Gaffney A, Otto CW, Singer AJ, Thiagarajan RR, Travers AH. Part 6: Alternative Techniques and Ancillary Devices for Cardiopulmonary Resuscitation: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S436-43. doi: 10.1161/CIR.0000000000000260. No abstract available.
- Background: PubMed 31045914Cho SM, Ziai W, Mayasi Y, Gusdon AM, Creed J, Sharrock M, Stephens RS, Choi CW, Ritzl EK, Suarez J, Whitman G, Geocadin RG. Noninvasive Neurological Monitoring in Extracorporeal Membrane Oxygenation. ASAIO J. 2020 Apr;66(4):388-393. doi: 10.1097/MAT.0000000000001013.
- Background: PubMed 32897296Sheth KN, Mazurek MH, Yuen MM, Cahn BA, Shah JT, Ward A, Kim JA, Gilmore EJ, Falcone GJ, Petersen N, Gobeske KT, Kaddouh F, Hwang DY, Schindler J, Sansing L, Matouk C, Rothberg J, Sze G, Siner J, Rosen MS, Spudich S, Kimberly WT. Assessment of Brain Injury Using Portable, Low-Field Magnetic Resonance Imaging at the Bedside of Critically Ill Patients. JAMA Neurol. 2020 Sep 8;78(1):41-7. doi: 10.1001/jamaneurol.2020.3263. Online ahead of print.
- Background: PubMed 31573398Campbell-Washburn AE, Ramasawmy R, Restivo MC, Bhattacharya I, Basar B, Herzka DA, Hansen MS, Rogers T, Bandettini WP, McGuirt DR, Mancini C, Grodzki D, Schneider R, Majeed W, Bhat H, Xue H, Moss J, Malayeri AA, Jones EC, Koretsky AP, Kellman P, Chen MY, Lederman RJ, Balaban RS. Opportunities in Interventional and Diagnostic Imaging by Using High-Performance Low-Field-Strength MRI. Radiology. 2019 Nov;293(2):384-393. doi: 10.1148/radiol.2019190452. Epub 2019 Oct 1.
- Background: PubMed 15104797Formica D, Silvestri S. Biological effects of exposure to magnetic resonance imaging: an overview. Biomed Eng Online. 2004 Apr 22;3:11. doi: 10.1186/1475-925X-3-11.
- Background: PubMed 19578460Hartwig V, Giovannetti G, Vanello N, Lombardi M, Landini L, Simi S. Biological effects and safety in magnetic resonance imaging: a review. Int J Environ Res Public Health. 2009 Jun;6(6):1778-98. doi: 10.3390/ijerph6061778. Epub 2009 Jun 10.
- Background: PubMed 9680568Shellock FG, Crues JV. Aneurysm clips: assessment of magnetic field interaction associated with a 0.2-T extremity MR system. Radiology. 1998 Aug;208(2):407-9. doi: 10.1148/radiology.208.2.9680568.
- Background: PubMed 16885635Alorainy IA, Albadr FB, Abujamea AH. Attitude towards MRI safety during pregnancy. Ann Saudi Med. 2006 Jul-Aug;26(4):306-9. doi: 10.5144/0256-4947.2006.306. No abstract available.
- Individual participant dataSharing planned: No. Clinical Study report will be available upon completion of the study analysis
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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.
Sung Min Cho, DO principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extracorporeal Membrane Oxygenation Complication and Acute Brain Injury, run by Johns Hopkins University at 2 sites 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 3 inclusion and 13 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 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Acute brain injury as assessed by head CT scan (time frame: 48 hours from ECMO initiation). 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 NCT05469139, which also lists 12 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 13 Mar 2024.