Traumatic Brain InjurySynapseICUNCT03257904
iNtrAcranial PreSsurE in Intensive Care (ICU) (SynapseICU)
An observational study of Traumatic Brain Injury and Subarachnoid Hemorrhage, run by University of Milano Bicocca at 1 site in Italy.
Trial summary
Intracranial pressure (ICP) monitoring is the most common neuromonitoring modality used in neurocritical care units (NCCU) around the world. Uncertainties remain around intracranial pressure monitoring both in traumatic and non-traumatic brain injury, and variation in clinical practice of intracranial pressure… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Subarachnoid Hemorrhage, Intracerebral Hemorrhage
- What is being tested?
- intracranial pressure monitoring
- Type of treatment
- Surgery or procedure
- How many people
- 2,395 participants
- Where
- 1 siteItaly
- Study dates
- 15 Mar 2018to 11 Jun 2020
- 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: Hemorrhagic stroke, including intracerebral hematoma and subarachnoid hemorrhage, Traumatic brain injury
Who may be able to join
- Age > 18 years;
- Diagnosis of an acute brain injury (ABI) due to primary hemorrhagic stroke (including intracranial hemorrhage or subarachnoid hemorrhage) or traumatic brain injury;
- Glasgow Coma Score with Eyes response = 1 (no eyes opening) and Motor score ≤5 (not following commands) at the admission to ICU or neuro-worsening within the first 48 hours with no eye opening and the Motor score decreased to ≤5.
Who cannot join
- Acute Brain Injury (ABI) who are not admitted to ICU;
- ABI due to infections of the central nervous system, ischaemic stroke or other causes not defined in the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: International Prospective Observational StudY on iNtrAcranial PreSsurE in Intensive Care (ICU) (SynapseICU)
Intracranial pressure (ICP) monitoring is the most common neuromonitoring modality used in neurocritical care units (NCCU) around the world. Uncertainties remain around intracranial pressure monitoring both in traumatic and non-traumatic brain injury, and variation in clinical practice of intracranial pressure monitoring exists between neurocritical care units.
The objectives of the study will explore intracranial pressure monitoring variation in practice to prioritise uncertainties in the clinical management of critical care patients with acute brain injury and support further collaborative hypotheses-based prospective studies.
Read the detailed description
Intracranial pressure (ICP) monitoring is the most common neuromonitoring modality used in neurocritical care units (NCCU) around the world. Uncertainties remain around intracranial pressure monitoring both in traumatic and non-traumatic brain injury, and variation in clinical practice of intracranial pressure monitoring exists between neurocritical care units.
The objectives of the study will explore intracranial pressure monitoring variation in practice to prioritise uncertainties in the clinical management of critical care patients with acute brain injury and support further collaborative hypotheses-based prospective studies.
Sample Size: This international prospective observational study aims to recruit >2000 patients in coma after acute traumatic and non-traumatic brain damage admitted to >200 Intensive Care Units.
Inclusion Criteria:
- Acute brain injury (ABI) admitted to ICU following:
- Hemorrhagic stroke, including intracerebral hematoma and subarachnoid hemorrhage,
- Traumatic brain injury (penetrating and non-penetrating).
- Age >18 years old
- Glasgow Coma Score with Eyes response = 1 (no eyes opening) and Motor score ≤5 (not following commands) at the admission to ICU or neuro-worsening within the first 48 hours with no eye opening and the Motor score decreased to ≤5
Exclusion Criteria:
- ABI who are not admitted to ICU;
- ABI due to infections of the central nervous system, ischemic stroke or other causes not defined in the inclusion criteria
Outcome measures:
Glasgow Outcome Score-Extended at 6 months
Endpoint:
The primary endpoint is the variation in clinical practice around ICP monitoring in acute brain injury patients.
Screening and recruitment: 12 weeks at each centre, or the duration required to enrol 90 patients per centre.
Follow-up: outcome measures will be collected at 6 months.
Duration of study: 2 years.
The SYNAPSE-ICU study is partly funded by ESICM (ESICM Trials Group Portfolio).
- Being tested
- intracranial pressure monitoring
- Keywords
- intracranial pressure
- Medical subject headings
- Brain Injuries, Traumatic, Subarachnoid Hemorrhage, Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intracranial pressure monitoringProcedure or surgery
measurement of intracranial pressure
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term outcome measures of neurological disability
Extended Glasgow Outcome Scale score
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start15 Mar 2018
- Primary completion31 Dec 2019
- Study completion11 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,395 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Collaborators
- European Society of Intensive Care Medicine
- Responsible party
- Principal investigator, Giuseppe Citerio, MD, University of Milano Bicocca
- Investigators
- Giuseppe Citerio, Principal investigator, University Milano Bicocca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257904
- Sponsor's protocol ID
- SynapseICU
- Acronym
- SynapseICU
- Status last verified
- Jul 2020
- First submitted
- 17 Aug 2017
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stocchetti N, Carbonara M, Citerio G, Ercole A, Skrifvars MB, Smielewski P, Zoerle T, Menon DK. Severe traumatic brain injury: targeted management in the intensive care unit. Lancet Neurol. 2017 Jun;16(6):452-464. doi: 10.1016/S1474-4422(17)30118-7.
PubMed 28504109Carney N, Totten AM, O'Reilly C, Ullman JS, Hawryluk GW, Bell MJ, Bratton SL, Chesnut R, Harris OA, Kissoon N, Rubiano AM, Shutter L, Tasker RC, Vavilala MS, Wilberger J, Wright DW, Ghajar J. Guidelines for the Management of Severe Traumatic Brain Injury, Fourth Edition. Neurosurgery. 2017 Jan 1;80(1):6-15. doi: 10.1227/NEU.0000000000001432.
PubMed 27654000Cnossen MC, Scholten AC, Lingsma HF, Synnot A, Tavender E, Gantner D, Lecky F, Steyerberg EW, Polinder S. Adherence to Guidelines in Adult Patients with Traumatic Brain Injury: A Living Systematic Review. J Neurotrauma. 2021 Apr 15;38(8):1072-1085. doi: 10.1089/neu.2015.4121. Epub 2016 Aug 25.
PubMed 26431625Helbok R, Olson DM, Le Roux PD, Vespa P; Participants in the International Multidisciplinary Consensus Conference on Multimodality Monitoring. Intracranial pressure and cerebral perfusion pressure monitoring in non-TBI patients: special considerations. Neurocrit Care. 2014 Dec;21 Suppl 2:S85-94. doi: 10.1007/s12028-014-0040-6.
PubMed 25208677Chesnut RM, Bleck TP, Citerio G, Classen J, Cooper DJ, Coplin WM, Diringer MN, Grande PO, Hemphill JC 3rd, Hutchinson PJ, Le Roux P, Mayer SA, Menon DK, Myburgh JA, Okonkwo DO, Robertson CS, Sahuquillo J, Stocchetti N, Sung G, Temkin N, Vespa PM, Videtta W, Yonas H. A Consensus-Based Interpretation of the Benchmark Evidence from South American Trials: Treatment of Intracranial Pressure Trial. J Neurotrauma. 2015 Nov 15;32(22):1722-4. doi: 10.1089/neu.2015.3976. Epub 2015 Aug 31.
PubMed 26061135Hemphill JC 3rd, Greenberg SM, Anderson CS, Becker K, Bendok BR, Cushman M, Fung GL, Goldstein JN, Macdonald RL, Mitchell PH, Scott PA, Selim MH, Woo D; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology. Guidelines for the Management of Spontaneous Intracerebral Hemorrhage: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2015 Jul;46(7):2032-60. doi: 10.1161/STR.0000000000000069. Epub 2015 May 28.
PubMed 26022637Chesnut R, Videtta W, Vespa P, Le Roux P; Participants in the International Multidisciplinary Consensus Conference on Multimodality Monitoring. Intracranial pressure monitoring: fundamental considerations and rationale for monitoring. Neurocrit Care. 2014 Dec;21 Suppl 2:S64-84. doi: 10.1007/s12028-014-0048-y.
PubMed 25208680Le Roux P, Menon DK, Citerio G, Vespa P, Bader MK, Brophy GM, Diringer MN, Stocchetti N, Videtta W, Armonda R, Badjatia N, Boesel J, Chesnut R, Chou S, Claassen J, Czosnyka M, De Georgia M, Figaji A, Fugate J, Helbok R, Horowitz D, Hutchinson P, Kumar M, McNett M, Miller C, Naidech A, Oddo M, Olson D, O'Phelan K, Provencio JJ, Puppo C, Riker R, Robertson C, Schmidt M, Taccone F; Neurocritical Care Society; European Society of Intensive Care Medicine. Consensus summary statement of the International Multidisciplinary Consensus Conference on Multimodality Monitoring in Neurocritical Care : a statement for healthcare professionals from the Neurocritical Care Society and the European Society of Intensive Care Medicine. Intensive Care Med. 2014 Sep;40(9):1189-209. doi: 10.1007/s00134-014-3369-6. Epub 2014 Aug 20.
PubMed 25138226Stocchetti N, Maas AI. Traumatic intracranial hypertension. N Engl J Med. 2014 Sep 4;371(10):972. doi: 10.1056/NEJMc1407775. No abstract available.
PubMed 25184881Wilson JT, Pettigrew LE, Teasdale GM. Structured interviews for the Glasgow Outcome Scale and the extended Glasgow Outcome Scale: guidelines for their use. J Neurotrauma. 1998 Aug;15(8):573-85. doi: 10.1089/neu.1998.15.573.
PubMed 9726257Cossu G, Messerer M, Stocchetti N, Levivier M, Daniel RT, Oddo M. Intracranial pressure and outcome in critically ill patients with aneurysmal subarachnoid hemorrhage: a systematic review. Minerva Anestesiol. 2016 Jun;82(6):684-96. Epub 2016 Apr 5.
PubMed 27045637Citerio G, Oddo M, Taccone FS. Recommendations for the use of multimodal monitoring in the neurointensive care unit. Curr Opin Crit Care. 2015 Apr;21(2):113-9. doi: 10.1097/MCC.0000000000000179.
PubMed 25689123Stocchetti N, Le Roux P, Vespa P, Oddo M, Citerio G, Andrews PJ, Stevens RD, Sharshar T, Taccone FS, Vincent JL. Clinical review: neuromonitoring - an update. Crit Care. 2013 Jan 15;17(1):201. doi: 10.1186/cc11513.
PubMed 23320763Robba C, Graziano F, Guglielmi A, Rebora P, Galimberti S, Taccone FS, Citerio G; SYNAPSE-ICU Investigators. Treatments for intracranial hypertension in acute brain-injured patients: grading, timing, and association with outcome. Data from the SYNAPSE-ICU study. Intensive Care Med. 2023 Jan;49(1):50-61. doi: 10.1007/s00134-022-06937-1. Epub 2023 Jan 9.
PubMed 36622462Dallagiacoma S, Robba C, Graziano F, Rebora P, Hemphill JC, Galimberti S, Citerio G; SYNAPSE-ICU Investigators. Intracranial Pressure Monitoring in Patients With Spontaneous Intracerebral Hemorrhage: Insights From the SYNAPSE-ICU Study. Neurology. 2022 Jul 12;99(2):e98-e108. doi: 10.1212/WNL.0000000000200568. Epub 2022 May 4.
PubMed 35508390
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Prospective Observational StudY on iNtrAcranial PreSsurE in Intensive Care (ICU) (SynapseICU)
- ClinicalTrials.gov ID
- NCT03257904
- Acronym / sponsor ID
- SynapseICU / SynapseICU
- Keywords
- intracranial pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,395 participants (actual)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Collaborators
- European Society of Intensive Care Medicine
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 11 Jun 2020 (actual)
- First posted
- 22 Aug 2017 (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.
Intracranial pressure (ICP) monitoring is the most common neuromonitoring modality used in neurocritical care units (NCCU) around the world. Uncertainties remain around intracranial pressure monitoring both in traumatic and non-traumatic brain injury, and variation in clinical practice of intracranial pressure monitoring exists between neurocritical care units.
The objectives of the study will explore intracranial pressure monitoring variation in practice to prioritise uncertainties in the clinical management of critical care patients with acute brain injury and support further collaborative hypotheses-based prospective studies.
Detailed description
Intracranial pressure (ICP) monitoring is the most common neuromonitoring modality used in neurocritical care units (NCCU) around the world. Uncertainties remain around intracranial pressure monitoring both in traumatic and non-traumatic brain injury, and variation in clinical practice of intracranial pressure monitoring exists between neurocritical care units.
The objectives of the study will explore intracranial pressure monitoring variation in practice to prioritise uncertainties in the clinical management of critical care patients with acute brain injury and support further collaborative hypotheses-based prospective studies.
Sample Size: This international prospective observational study aims to recruit >2000 patients in coma after acute traumatic and non-traumatic brain damage admitted to >200 Intensive Care Units.
Inclusion Criteria:
- Acute brain injury (ABI) admitted to ICU following:
- Hemorrhagic stroke, including intracerebral hematoma and subarachnoid hemorrhage,
- Traumatic brain injury (penetrating and non-penetrating).
- Age >18 years old
- Glasgow Coma Score with Eyes response = 1 (no eyes opening) and Motor score ≤5 (not following commands) at the admission to ICU or neuro-worsening within the first 48 hours with no eye opening and the Motor score decreased to ≤5
Exclusion Criteria:
- ABI who are not admitted to ICU;
- ABI due to infections of the central nervous system, ischemic stroke or other causes not defined in the inclusion criteria
Outcome measures:
Glasgow Outcome Score-Extended at 6 months
Endpoint:
The primary endpoint is the variation in clinical practice around ICP monitoring in acute brain injury patients.
Screening and recruitment: 12 weeks at each centre, or the duration required to enrol 90 patients per centre.
Follow-up: outcome measures will be collected at 6 months.
Duration of study: 2 years.
The SYNAPSE-ICU study is partly funded by ESICM (ESICM Trials Group Portfolio).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hemorrhagic stroke, including intracerebral hematoma and subarachnoid hemorrhage, Traumatic brain injury
Key inclusion criteria (3 listed)
- Age > 18 years;
- Diagnosis of an acute brain injury (ABI) due to primary hemorrhagic stroke (including intracranial hemorrhage or subarachnoid hemorrhage) or traumatic brain injury;
- Glasgow Coma Score with Eyes response = 1 (no eyes opening) and Motor score ≤5 (not following commands) at the admission to ICU or neuro-worsening within the first 48 hours with no eye opening and the Motor score decreased to ≤5.
Key exclusion criteria (2 listed)
- Acute Brain Injury (ABI) who are not admitted to ICU;
- ABI due to infections of the central nervous system, ischaemic stroke or other causes not defined in the inclusion criteria.
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 |
|---|---|---|
| intracranial pressure monitoringmeasurement of intracranial pressure | Procedure or surgery | – |
Primary outcome
Long-term outcome measures of neurological disability
Time frame: 6 months
Extended Glasgow Outcome Scale score
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 7 Jul 2020.
- Background: PubMed 28504109Stocchetti N, Carbonara M, Citerio G, Ercole A, Skrifvars MB, Smielewski P, Zoerle T, Menon DK. Severe traumatic brain injury: targeted management in the intensive care unit. Lancet Neurol. 2017 Jun;16(6):452-464. doi: 10.1016/S1474-4422(17)30118-7.
- Background: PubMed 27654000Carney N, Totten AM, O'Reilly C, Ullman JS, Hawryluk GW, Bell MJ, Bratton SL, Chesnut R, Harris OA, Kissoon N, Rubiano AM, Shutter L, Tasker RC, Vavilala MS, Wilberger J, Wright DW, Ghajar J. Guidelines for the Management of Severe Traumatic Brain Injury, Fourth Edition. Neurosurgery. 2017 Jan 1;80(1):6-15. doi: 10.1227/NEU.0000000000001432.
- Background: PubMed 26431625Cnossen MC, Scholten AC, Lingsma HF, Synnot A, Tavender E, Gantner D, Lecky F, Steyerberg EW, Polinder S. Adherence to Guidelines in Adult Patients with Traumatic Brain Injury: A Living Systematic Review. J Neurotrauma. 2021 Apr 15;38(8):1072-1085. doi: 10.1089/neu.2015.4121. Epub 2016 Aug 25.
- Background: PubMed 25208677Helbok R, Olson DM, Le Roux PD, Vespa P; Participants in the International Multidisciplinary Consensus Conference on Multimodality Monitoring. Intracranial pressure and cerebral perfusion pressure monitoring in non-TBI patients: special considerations. Neurocrit Care. 2014 Dec;21 Suppl 2:S85-94. doi: 10.1007/s12028-014-0040-6.
- Background: PubMed 26061135Chesnut RM, Bleck TP, Citerio G, Classen J, Cooper DJ, Coplin WM, Diringer MN, Grande PO, Hemphill JC 3rd, Hutchinson PJ, Le Roux P, Mayer SA, Menon DK, Myburgh JA, Okonkwo DO, Robertson CS, Sahuquillo J, Stocchetti N, Sung G, Temkin N, Vespa PM, Videtta W, Yonas H. A Consensus-Based Interpretation of the Benchmark Evidence from South American Trials: Treatment of Intracranial Pressure Trial. J Neurotrauma. 2015 Nov 15;32(22):1722-4. doi: 10.1089/neu.2015.3976. Epub 2015 Aug 31.
- Background: PubMed 26022637Hemphill JC 3rd, Greenberg SM, Anderson CS, Becker K, Bendok BR, Cushman M, Fung GL, Goldstein JN, Macdonald RL, Mitchell PH, Scott PA, Selim MH, Woo D; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology. Guidelines for the Management of Spontaneous Intracerebral Hemorrhage: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2015 Jul;46(7):2032-60. doi: 10.1161/STR.0000000000000069. Epub 2015 May 28.
- Background: PubMed 25208680Chesnut R, Videtta W, Vespa P, Le Roux P; Participants in the International Multidisciplinary Consensus Conference on Multimodality Monitoring. Intracranial pressure monitoring: fundamental considerations and rationale for monitoring. Neurocrit Care. 2014 Dec;21 Suppl 2:S64-84. doi: 10.1007/s12028-014-0048-y.
- Background: PubMed 25138226Le Roux P, Menon DK, Citerio G, Vespa P, Bader MK, Brophy GM, Diringer MN, Stocchetti N, Videtta W, Armonda R, Badjatia N, Boesel J, Chesnut R, Chou S, Claassen J, Czosnyka M, De Georgia M, Figaji A, Fugate J, Helbok R, Horowitz D, Hutchinson P, Kumar M, McNett M, Miller C, Naidech A, Oddo M, Olson D, O'Phelan K, Provencio JJ, Puppo C, Riker R, Robertson C, Schmidt M, Taccone F; Neurocritical Care Society; European Society of Intensive Care Medicine. Consensus summary statement of the International Multidisciplinary Consensus Conference on Multimodality Monitoring in Neurocritical Care : a statement for healthcare professionals from the Neurocritical Care Society and the European Society of Intensive Care Medicine. Intensive Care Med. 2014 Sep;40(9):1189-209. doi: 10.1007/s00134-014-3369-6. Epub 2014 Aug 20.
- Background: PubMed 25184881Stocchetti N, Maas AI. Traumatic intracranial hypertension. N Engl J Med. 2014 Sep 4;371(10):972. doi: 10.1056/NEJMc1407775. No abstract available.
- Background: PubMed 9726257Wilson JT, Pettigrew LE, Teasdale GM. Structured interviews for the Glasgow Outcome Scale and the extended Glasgow Outcome Scale: guidelines for their use. J Neurotrauma. 1998 Aug;15(8):573-85. doi: 10.1089/neu.1998.15.573.
- Background: PubMed 27045637Cossu G, Messerer M, Stocchetti N, Levivier M, Daniel RT, Oddo M. Intracranial pressure and outcome in critically ill patients with aneurysmal subarachnoid hemorrhage: a systematic review. Minerva Anestesiol. 2016 Jun;82(6):684-96. Epub 2016 Apr 5.
- Background: PubMed 25689123Citerio G, Oddo M, Taccone FS. Recommendations for the use of multimodal monitoring in the neurointensive care unit. Curr Opin Crit Care. 2015 Apr;21(2):113-9. doi: 10.1097/MCC.0000000000000179.
- 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.
Giuseppe Citerio principal investigator
University Milano Bicocca
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 Traumatic Brain Injury and Subarachnoid Hemorrhage, run by University of Milano Bicocca at 1 site in Italy.
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 2 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 7 Jul 2020. 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 Italy. 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?
Long-term outcome measures of neurological disability (time frame: 6 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 NCT03257904, which also lists 17 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 7 Jul 2020.