PolytraumaNCT05544773
Comparing Trauma Severity Scores Injury Severity Score "ISS", Rapid Emergency Medicine Score "REMS" and Kampala Trauma Score "KTS"
An observational study of Polytrauma, run by Assiut University.
Trial summary
Trauma is defined as a physical injury from an external source of sudden onset and severity, which require immediate medical attention.Despite improvements in trauma systems worldwide, trauma continues to be one of the leading causes of death and disability in all age groups, especially the young and middle age group. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Polytrauma
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 1 Oct 2025
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: traumatic patients with multiple trauma of both genders "without intently selected certain gender" and had 18 years old or more.
Who may be able to join
- traumatic patients with multiple trauma
- Both genders "without intently selected certain gender" and had 18 years old or more.
Who cannot join
- Patients who are less than 18 years old.
- Patients with end stage chronic disease .
- Patients with localized individual trauma will be excluded from this study.
- Patients refusing study .
About this study
Official title: Comparing Trauma Severity Scores Injury Severity Score "ISS", Rapid Emergency Medicine Score "REMS" and Kampala Trauma Score "KTS" in Polytrauma Patients for Survival Prediction and ICU Admission in Assiut and Suez Canal University Hospitals.
Trauma is defined as a physical injury from an external source of sudden onset and severity, which require immediate medical attention.Despite improvements in trauma systems worldwide, trauma continues to be one of the leading causes of death and disability in all age groups, especially the young and middle age group.
For studying the outcomes of trauma, accurate and reliable methodological tools are required for appropriate scoring of severity and outcome prediction . Trauma scores were designed to facilitate the triage of patients in the ER (emergency room), and identify patients with Polytrauma with low chances of survival. Those scores were meant to organize and improve the quality of trauma care systems, and to assess resources allocation.3 12 In 1969, Researchers developed the Abbreviated Injury Scale (AIS) to grade the severity of individual injuries. Attempting to summarize injury severity in patients with multiple traumas with a single number is almost difficult; therefore, multiple alternative scoring systems were proposed afterwards, each with its own problems and limitations.
More than 50 scoring systems have been published for the classification of trauma patients in the field, emergency room, and intensive care settings. There are three main groups of trauma scores: (a) Anatomical, (b) Physiological, (c) Combined scores. Anatomical scores describe all the injuries recorded by clinical examination, imaging, surgery or autopsy and measure lesion severity. Physiological scores describe changes happened due to the trauma, and translated by changes in vital signs and consciousness. Scores that include both anatomical and physiological criteria (mixed scores) are more useful for patient prognosis
Read the detailed description
Trauma is defined as a physical injury from an external source of sudden onset and severity, which require immediate medical attention.Despite improvements in trauma systems worldwide, trauma continues to be one of the leading causes of death and disability in all age groups, especially the young and middle age group.
Approximately 5.8 million people die each year due to trauma related injuries, representing 8% of the worldwide mortality.Polytrauma is a short verbal equivalent commonly used for severely injured patients usually with associated injury (i.e. two or more severe injuries in at least two different areas of the body), less often with a multiple injury (i.e. two or more severe injuries in one body area).
Polytrauma patients usually have a much higher risk of mortalities and disabilities than the risk of expected mortalities in individual injuries patients. Even though polytrauma can occur due to different causes such as road traffic accidents, fall from heights, bullet injuries, suicide and homicide7.Yet the leading cause of traumatic related causes of death worldwide is road traffic accidents.8 Egypt, in particular, has experienced an alarming increase in the burden of traumatic injuries. According to the World Health Organization In 2015 Egypt has one of the highest rates of road accidents worldwide, with more than 12,000 fatalities each year, one of the highest among EMR countries. Although 90% of world's road trauma related fatalities occur in low- and middle-income countries, Injury prevention and trauma care programs in these countries have remained deficient.
For studying the outcomes of trauma, accurate and reliable methodological tools are required for appropriate scoring of severity and outcome prediction . Trauma scores were designed to facilitate the triage of patients in the ER (emergency room), and identify patients with Polytrauma with low chances of survival. Those scores were meant to organize and improve the quality of trauma care systems, and to assess resources allocation. In 1969, Researchers developed the Abbreviated Injury Scale (AIS) to grade the severity of individual injuries. Attempting to summarize injury severity in patients with multiple traumas with a single number is almost difficult; therefore, multiple alternative scoring systems were proposed afterwards, each with its own problems and limitations.
More than 50 scoring systems have been published for the classification of trauma patients in the field, emergency room, and intensive care settings. There are three main groups of trauma scores: (a) Anatomical, (b) Physiological, (c) Combined scores.
Anatomical scores describe all the injuries recorded by clinical examination, imaging, surgery or autopsy and measure lesion severity. Physiological scores describe changes happened due to the trauma, and translated by changes in vital signs and consciousness. Scores that include both anatomical and physiological criteria (mixed scores) are more useful for patient prognosis
The three types of scores can be combined in different ways to obtain more accurate information from all the possible aspects141- Anatomical Scoring Systems: Abbreviated injury scale (AIS) - Injury severity score (ISS) -New injury severity score (NISS) -Organ injury scale (OIS) - Anatomic profile -International Classification of Diseases (ICD-9) Injury Severity Score (ICISS) 2- Physiological Scoring Systems: Revised trauma score - Glasgow coma score - APACHE scoring (Acute physiology and chronic health evaluation - (APACHE I, II, III) -Rapid Emergency Medicine Score (REMS)3- Combined Anatomical and Physiological Scoring Systems :Trauma and injury severity scores (TRISS) - A severity characterization of trauma (ASCOT)-Kampala Trauma Score (KTS)
What does each score mean? Injury Severity Score (ISS): The injury severity score (ISS) is an anatomical scoring system which provides an overall score for patients with multiple injuries. Each injury is assigned an abbreviated injury scale (AIS) score and allocated to one of six body regions. The highest AIS score of each body region is used. The three most severely injured body regions scores are squared and added together to produce the ISS score.
Rapid Emergency Medicine Score (REMS): Rapid Emergency Medicine Score (REMS) is a newly developed scoring system developed to overcome drawbacks of other scoring systems. It is a simplified version of the APACHE II that allows for rapid score calculation. The REMS is calculated based on the patient's Glasgow Coma Scale (GCS), respiratory rate (RR), oxygen saturation, mean arterial pressure (MAP), heart rate (HR), and age.
Kampala Trauma Score (KTS): A new severity score, Kampala Trauma Score (KTS), was introduced as an injury severity score in settings without advanced diagnostics. This is a simplified composite of the Revised Trauma Score (RTS) and the Injury Severity Score (ISS). The KTS has been validated for its ability to predict outcome in the Ugandan trauma registry.
- Conditions
- Polytrauma
- Medical subject headings
- Multiple Trauma
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality "death" during the 30 day follow-up
Measured: 30 days
Secondary outcomes (3)
Hospital admission
Admission to hospital from the Emergency Department
Measured: Day 0
Intensive Care Unit admission
Admission to the Intensive Care Unit or High Dependency Unit from the Emergency Department
Measured: Day 0
Readmission in the Emergency Department
Re-visits to the Emergency Department after the index-visit.
Measured: Hour 72, Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for PolytraumaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Nassar, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05544773
- Sponsor's protocol ID
- ISS-REMS-KTS
- Status last verified
- Sep 2022
- First submitted
- 11 Sep 2022
- Last updated
- 16 Sep 2022
- Results posted
- No
- Individual data sharing
- Undecided
Publications
Lendrum RA, Lockey DJ. Trauma system development. Anaesthesia. 2013 Jan;68 Suppl 1:30-9. doi: 10.1111/anae.12049.
PubMed 23210554UF Health U of FH. Traumatic Injury. Published October 12, 2016. Accessed August 20, 2022. https://ufhealth.org/traumatic-injury
Cernea D, Novac M, Dragoescu PO, Stanculescu A, Duca L, Al-Enezy AA, Dragoescu NA. Polytrauma and Multiple Severity Scores. Curr Health Sci J. 2014 Oct-Dec;40(4):244-8. doi: 10.12865/CHSJ.40.04.02. Epub 2014 Dec 14.
PubMed 26793320World Health Organization. Injuries and violence. Published March 19, 2021. Accessed August 20, 2022. https://www.who.int/news-room/fact-sheets/detail/injuries-and-violence
Rau CS, Wu SC, Kuo PJ, Chen YC, Chien PC, Hsieh HY, Hsieh CH. Polytrauma Defined by the New Berlin Definition: A Validation Test Based on Propensity-Score Matching Approach. Int J Environ Res Public Health. 2017 Sep 11;14(9):1045. doi: 10.3390/ijerph14091045.
PubMed 28891977Marsden NJ, Tuma F. Polytraumatized Patient. StatPearls ; 2022. Accessed August 20, 2022. https://www.ncbi.nlm.nih.gov/books/NBK554426/
Bikbov B, Perico N, Remuzzi G. Mortality landscape in the global burden of diseases, injuries and risk factors study. Eur J Intern Med. 2014 Jan;25(1):1-5. doi: 10.1016/j.ejim.2013.09.002. Epub 2013 Sep 29.
PubMed 24084027The Global Road Safety Facility (GRSF), World Health Organization. Egypt's Road Safety Country Profile. Published 2016. Accessed August 20, 2022. https://www.roadsafetyfacility.org/country/egypt
Elachi IC, Yongu WT, Odoyoh OO, Mue DD, Ogwuche EI, Ahachi CN. An epidemiological study of the burden of trauma in Makurdi, Nigeria. Int J Crit Illn Inj Sci. 2015 Apr-Jun;5(2):99-102. doi: 10.4103/2229-5151.158404.
PubMed 26157653Guzzo JL, Bochicchio GV, Napolitano LM, Malone DL, Meyer W, Scalea TM. Prediction of outcomes in trauma: anatomic or physiologic parameters? J Am Coll Surg. 2005 Dec;201(6):891-7. doi: 10.1016/j.jamcollsurg.2005.07.013. Epub 2005 Oct 13.
PubMed 16310692Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med. 1985 Oct;13(10):818-29.
PubMed 3928249Le Gall JR. The use of severity scores in the intensive care unit. Intensive Care Med. 2005 Dec;31(12):1618-23. doi: 10.1007/s00134-005-2825-8. Epub 2005 Oct 22. No abstract available.
PubMed 16244878Beuran M, Negoi I, Paun S, Runcanu A, Gaspar B, Vartic M. [Trauma scores: a review of the literature]. Chirurgia (Bucur). 2012 May-Jun;107(3):291-7. Romanian.
PubMed 22844826Javali RH, Krishnamoorthy, Patil A, Srinivasarangan M, Suraj, Sriharsha. Comparison of Injury Severity Score, New Injury Severity Score, Revised Trauma Score and Trauma and Injury Severity Score for Mortality Prediction in Elderly Trauma Patients. Indian J Crit Care Med. 2019 Feb;23(2):73-77. doi: 10.5005/jp-journals-10071-23120.
PubMed 31086450Baker SP, O'Neill B, Haddon W Jr, Long WB. The injury severity score: a method for describing patients with multiple injuries and evaluating emergency care. J Trauma. 1974 Mar;14(3):187-96. No abstract available.
PubMed 4814394
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Trauma Severity Scores Injury Severity Score "ISS", Rapid Emergency Medicine Score "REMS" and Kampala Trauma Score "KTS" in Polytrauma Patients for Survival Prediction and ICU Admission in Assiut and Suez Canal University Hospitals.
- ClinicalTrials.gov ID
- NCT05544773
- Acronym / sponsor ID
- ISS-REMS-KTS
- Conditions
- Polytrauma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 16 Sep 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.
Trauma is defined as a physical injury from an external source of sudden onset and severity, which require immediate medical attention.Despite improvements in trauma systems worldwide, trauma continues to be one of the leading causes of death and disability in all age groups, especially the young and middle age group.
For studying the outcomes of trauma, accurate and reliable methodological tools are required for appropriate scoring of severity and outcome prediction . Trauma scores were designed to facilitate the triage of patients in the ER (emergency room), and identify patients with Polytrauma with low chances of survival. Those scores were meant to organize and improve the quality of trauma care systems, and to assess resources allocation.3 12 In 1969, Researchers developed the Abbreviated Injury Scale (AIS) to grade the severity of individual injuries. Attempting to summarize injury severity in patients with multiple traumas with a single number is almost difficult; therefore, multiple alternative scoring systems were proposed afterwards, each with its own problems and limitations.
More than 50 scoring systems have been published for the classification of trauma patients in the field, emergency room, and intensive care settings. There are three main groups of trauma scores: (a) Anatomical, (b) Physiological, (c) Combined scores. Anatomical scores describe all the injuries recorded by clinical examination, imaging, surgery or autopsy and measure lesion severity. Physiological scores describe changes happened due to the trauma, and translated by changes in vital signs and consciousness. Scores that include both anatomical and physiological criteria (mixed scores) are more useful for patient prognosis
Detailed description
Trauma is defined as a physical injury from an external source of sudden onset and severity, which require immediate medical attention.Despite improvements in trauma systems worldwide, trauma continues to be one of the leading causes of death and disability in all age groups, especially the young and middle age group.
Approximately 5.8 million people die each year due to trauma related injuries, representing 8% of the worldwide mortality.Polytrauma is a short verbal equivalent commonly used for severely injured patients usually with associated injury (i.e. two or more severe injuries in at least two different areas of the body), less often with a multiple injury (i.e. two or more severe injuries in one body area).
Polytrauma patients usually have a much higher risk of mortalities and disabilities than the risk of expected mortalities in individual injuries patients. Even though polytrauma can occur due to different causes such as road traffic accidents, fall from heights, bullet injuries, suicide and homicide7.Yet the leading cause of traumatic related causes of death worldwide is road traffic accidents.8 Egypt, in particular, has experienced an alarming increase in the burden of traumatic injuries. According to the World Health Organization In 2015 Egypt has one of the highest rates of road accidents worldwide, with more than 12,000 fatalities each year, one of the highest among EMR countries. Although 90% of world's road trauma related fatalities occur in low- and middle-income countries, Injury prevention and trauma care programs in these countries have remained deficient.
For studying the outcomes of trauma, accurate and reliable methodological tools are required for appropriate scoring of severity and outcome prediction . Trauma scores were designed to facilitate the triage of patients in the ER (emergency room), and identify patients with Polytrauma with low chances of survival. Those scores were meant to organize and improve the quality of trauma care systems, and to assess resources allocation. In 1969, Researchers developed the Abbreviated Injury Scale (AIS) to grade the severity of individual injuries. Attempting to summarize injury severity in patients with multiple traumas with a single number is almost difficult; therefore, multiple alternative scoring systems were proposed afterwards, each with its own problems and limitations.
More than 50 scoring systems have been published for the classification of trauma patients in the field, emergency room, and intensive care settings. There are three main groups of trauma scores: (a) Anatomical, (b) Physiological, (c) Combined scores.
Anatomical scores describe all the injuries recorded by clinical examination, imaging, surgery or autopsy and measure lesion severity. Physiological scores describe changes happened due to the trauma, and translated by changes in vital signs and consciousness. Scores that include both anatomical and physiological criteria (mixed scores) are more useful for patient prognosis
The three types of scores can be combined in different ways to obtain more accurate information from all the possible aspects141- Anatomical Scoring Systems: Abbreviated injury scale (AIS) - Injury severity score (ISS) -New injury severity score (NISS) -Organ injury scale (OIS) - Anatomic profile -International Classification of Diseases (ICD-9) Injury Severity Score (ICISS) 2- Physiological Scoring Systems: Revised trauma score - Glasgow coma score - APACHE scoring (Acute physiology and chronic health evaluation - (APACHE I, II, III) -Rapid Emergency Medicine Score (REMS)3- Combined Anatomical and Physiological Scoring Systems :Trauma and injury severity scores (TRISS) - A severity characterization of trauma (ASCOT)-Kampala Trauma Score (KTS)
What does each score mean? Injury Severity Score (ISS): The injury severity score (ISS) is an anatomical scoring system which provides an overall score for patients with multiple injuries. Each injury is assigned an abbreviated injury scale (AIS) score and allocated to one of six body regions. The highest AIS score of each body region is used. The three most severely injured body regions scores are squared and added together to produce the ISS score.
Rapid Emergency Medicine Score (REMS): Rapid Emergency Medicine Score (REMS) is a newly developed scoring system developed to overcome drawbacks of other scoring systems. It is a simplified version of the APACHE II that allows for rapid score calculation. The REMS is calculated based on the patient's Glasgow Coma Scale (GCS), respiratory rate (RR), oxygen saturation, mean arterial pressure (MAP), heart rate (HR), and age.
Kampala Trauma Score (KTS): A new severity score, Kampala Trauma Score (KTS), was introduced as an injury severity score in settings without advanced diagnostics. This is a simplified composite of the Revised Trauma Score (RTS) and the Injury Severity Score (ISS). The KTS has been validated for its ability to predict outcome in the Ugandan trauma registry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- traumatic patients with multiple trauma of both genders "without intently selected certain gender" and had 18 years old or more.
Key inclusion criteria (2 listed)
- traumatic patients with multiple trauma
- Both genders "without intently selected certain gender" and had 18 years old or more.
Key exclusion criteria (4 listed)
- Patients who are less than 18 years old.
- Patients with end stage chronic disease .
- Patients with localized individual trauma will be excluded from this study.
- Patients refusing study .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: 30 days
Mortality "death" during the 30 day follow-up
3 secondary outcomes
Hospital admission
Time frame: Day 0
Intensive Care Unit admission
Time frame: Day 0
Readmission in the Emergency Department
Time frame: Hour 72, Day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
- Background: PubMed 23210554Lendrum RA, Lockey DJ. Trauma system development. Anaesthesia. 2013 Jan;68 Suppl 1:30-9. doi: 10.1111/anae.12049.
- BackgroundUF Health U of FH. Traumatic Injury. Published October 12, 2016. Accessed August 20, 2022. https://ufhealth.org/traumatic-injury
- Background: PubMed 26793320Cernea D, Novac M, Dragoescu PO, Stanculescu A, Duca L, Al-Enezy AA, Dragoescu NA. Polytrauma and Multiple Severity Scores. Curr Health Sci J. 2014 Oct-Dec;40(4):244-8. doi: 10.12865/CHSJ.40.04.02. Epub 2014 Dec 14.
- BackgroundWorld Health Organization. Injuries and violence. Published March 19, 2021. Accessed August 20, 2022. https://www.who.int/news-room/fact-sheets/detail/injuries-and-violence
- Background: PubMed 28891977Rau CS, Wu SC, Kuo PJ, Chen YC, Chien PC, Hsieh HY, Hsieh CH. Polytrauma Defined by the New Berlin Definition: A Validation Test Based on Propensity-Score Matching Approach. Int J Environ Res Public Health. 2017 Sep 11;14(9):1045. doi: 10.3390/ijerph14091045.
- BackgroundMarsden NJ, Tuma F. Polytraumatized Patient. StatPearls ; 2022. Accessed August 20, 2022. https://www.ncbi.nlm.nih.gov/books/NBK554426/
- Background: PubMed 24084027Bikbov B, Perico N, Remuzzi G. Mortality landscape in the global burden of diseases, injuries and risk factors study. Eur J Intern Med. 2014 Jan;25(1):1-5. doi: 10.1016/j.ejim.2013.09.002. Epub 2013 Sep 29.
- BackgroundThe Global Road Safety Facility (GRSF), World Health Organization. Egypt's Road Safety Country Profile. Published 2016. Accessed August 20, 2022. https://www.roadsafetyfacility.org/country/egypt
- Background: PubMed 26157653Elachi IC, Yongu WT, Odoyoh OO, Mue DD, Ogwuche EI, Ahachi CN. An epidemiological study of the burden of trauma in Makurdi, Nigeria. Int J Crit Illn Inj Sci. 2015 Apr-Jun;5(2):99-102. doi: 10.4103/2229-5151.158404.
- Background: PubMed 16310692Guzzo JL, Bochicchio GV, Napolitano LM, Malone DL, Meyer W, Scalea TM. Prediction of outcomes in trauma: anatomic or physiologic parameters? J Am Coll Surg. 2005 Dec;201(6):891-7. doi: 10.1016/j.jamcollsurg.2005.07.013. Epub 2005 Oct 13.
- Background: PubMed 3928249Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med. 1985 Oct;13(10):818-29.
- Background: PubMed 16244878Le Gall JR. The use of severity scores in the intensive care unit. Intensive Care Med. 2005 Dec;31(12):1618-23. doi: 10.1007/s00134-005-2825-8. Epub 2005 Oct 22. No abstract available.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Polytrauma, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Mortality (time frame: 30 days). 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 NCT05544773, which also lists 18 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 16 Sep 2022; AzTrials last refreshed its copy on 6 Nov 2026.