TraumaNCT04866953
UltraMTP in Adult Trauma Patients Undergoing Surgery Within 24 Hours: Effects on Mortality and Clinical Outcomes
An observational study of Trauma and Blood Transfusion Complication, run by University of Southern California at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of ultraMTP (>/=30 units pRBC within 24 hours) in trauma patients on mortality and secondary outcomes. The aim is to determine if there is a set number of pRBC units transfused in adult trauma patients undergoing surgery within 24 hours, after which mortality is… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Blood Transfusion Complication, Death
- What is being tested?
- Blood transfusion
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2021to 31 Dec 2023
- 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: Adult trauma patients who underwent surgery within the first 24 hours of admission, who received blood products in the first 24 hours.
Who may be able to join
- >/= 18 years old
- trauma patient
- undergoing surgery within first 24 hours of admission
- received blood products within 24 hours of admission
Who cannot join
- <18-years-old
- no surgery within the first 24 hours
- did not receive blood products within the first 24 hours
Trial locations and contacts
1 site in 1 country.
United States1 site
Keck School of Medicine of the University of Southern California
Los Angeles, California, 90033
About this study
Official title: At What Point is Blood Transfusion Futile in Trauma?: A Retrospective Study of Ultra Massive Transfusion Protocol in Adult Trauma Patients Undergoing Surgery Within 24 Hours and Effects on Mortality and Clinical Outcomes
The purpose of this study is to determine the effects of ultraMTP (>/=30 units pRBC within 24 hours) in trauma patients on mortality and secondary outcomes. The aim is to determine if there is a set number of pRBC units transfused in adult trauma patients undergoing surgery within 24 hours, after which mortality is inevitable and further transfusions are futile.
Read the detailed description
Rationale: To determine if there is a set number of pRBC units transfused in adult trauma patients undergoing surgery within 24 hours, after which mortality is inevitable and further transfusions are futile.
Intervention: Blood transfusions administered to adult trauma patients undergoing surgery within 24 hours of admission.
Objectives/Purpose: The main objective of this study is to examine the outcomes associated with large volume transfusions at U.S. level I trauma centers in adult trauma patients undergoing surgery within 24 hours of admission. The investigators aim to determine the mortality rate associated with ultraMTP (defined as >/= 30 units pRBC within 24 hours), and the effects of ultraMTP on secondary outcomes. The investigators would also like to compare outcomes among patients who receive various amounts of pRBC units within 24 hours. The information learned through this study will aid in determining whether there is a threshold transfusion amount, after which outcomes significantly worsen, and resuscitation efforts are futile and should cease, in order to save hospital resources, time, and costs.
Study Population/Sample Characteristics: Adult trauma patients requiring surgery within 24 hours of admission who receive blood products.
Study Methodology: This is a multicenter, retrospective observational study.
Study Endpoints/Outcomes:
- Primary outcome: 24-hour mortality (from the time of admission until 24 hours)
- Secondary outcomes: 1. ICU length of stay (LOS); 2. hospital LOS; 3. MV days; 4. Complications; 5. Multiple organ system failure; 6. in hospital mortality; 7. 30-day mortality; 8. discharge disposition.
Statistics/Analysis Plans:
The investigators will construct a logistic regression prediction model to 1) find the cut point classifications for pRBC units that optimize model prediction and 2) find additional variables that improve the predictive ability of our model. Previous studies on pRBC units and mortality have used different category cut points for pRBC units. The investigators will examine the functional form of pRBC units in its relationship with mortality to determine if there is a "plateau" effect of increasing pRBC units on mortality. The investigators will use this information to guide the classification of pRBC unit categories, comparing AIC values from several models with differing pRBC category classification cut off points to determine which of these are most highly associated with mortality. Using these categories, the investigators will then construct the prediction model, using the variables defined in Section 12. Interactions between these candidate predictors variables and pRBC units will additionally be considered. Model validation will be performed using k-folds cross-validation. Model performance will be evaluated by examining discriminative ability (area under ROC curve), calibration metrics, and optimism.
- Conditions
- Trauma, Blood Transfusion Complication, Death
- Being tested
- Blood transfusion
- Keywords
- trauma, massive transfusion protocol, ultra massive transfusion protocol, mortality, outcomes
- Medical subject headings
- Wounds and Injuries, Transfusion Reaction, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood transfusionOther
Number of units of blood received within 24 hours of admission
| Study group | Role | What they receive |
|---|---|---|
| <30 units PRBC | Patients who underwent surgery within 24 hours of admission and received less than 30 units of pRBC within 24 hours. Receives: Other: Blood transfusion | |
| >/=30 units PRBC | Patients who underwent surgery within 24 hours of admission and received >/=30 units of pRBC within 24 hours. Receives: Other: Blood transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour mortality
24-hour mortality (yes/no)
Measured: 24 hours
Secondary outcomes (8)
ICU length of stay
ICU length of stay (days)
Measured: through study completion, an average of 1 year
hospital length of stay
hospital length of stay (days)
Measured: through study completion, an average of 1 year
mechanical ventilator days
mechanical ventilator days
Measured: through study completion, an average of 1 year
complications
complications (yes/no)
Measured: through study completion, an average of 1 year
Multiple organ system failure
Multiple organ system failure (yes/no)
Measured: through study completion, an average of 1 year
In-hospital mortality
In-hospital mortality (yes/no)
Measured: through study completion, an average of 1 year
30-day mortality
30-day mortality (yes/no)
Measured: 30 days
discharge disposition
discharge disposition
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start15 Aug 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Retrospective
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Irvine, University of California, Davis, University of Texas, University of Miami, University of Chicago, Medical College of Wisconsin, Tulane University School of Medicine, University of Arkansas
- Responsible party
- Principal investigator, Catherine Kuza, MD, University of Southern California
- Investigators
- Catherine M Kuza, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04866953
- Sponsor's protocol ID
- APP-21-02050
- Status last verified
- Mar 2024
- First submitted
- 19 Apr 2021
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yu AJ, Inaba K, Biswas S, de Leon LA, Wong M, Benjamin E, Lam L, Demetriades D. Supermassive Transfusion: A 15-Year Single Center Experience and Outcomes. Am Surg. 2018 Oct 1;84(10):1617-1621.
PubMed 30747681Consunji R, Elseed A, El-Menyar A, Sathian B, Rizoli S, Al-Thani H, Peralta R. The effect of massive transfusion protocol implementation on the survival of trauma patients: a systematic review and meta-analysis. Blood Transfus. 2020 Nov;18(6):434-445. doi: 10.2450/2020.0065-20. Epub 2020 Sep 18.
PubMed 32955420Holcomb JB, Tilley BC, Baraniuk S, Fox EE, Wade CE, Podbielski JM, del Junco DJ, Brasel KJ, Bulger EM, Callcut RA, Cohen MJ, Cotton BA, Fabian TC, Inaba K, Kerby JD, Muskat P, O'Keeffe T, Rizoli S, Robinson BR, Scalea TM, Schreiber MA, Stein DM, Weinberg JA, Callum JL, Hess JR, Matijevic N, Miller CN, Pittet JF, Hoyt DB, Pearson GD, Leroux B, van Belle G; PROPPR Study Group. Transfusion of plasma, platelets, and red blood cells in a 1:1:1 vs a 1:1:2 ratio and mortality in patients with severe trauma: the PROPPR randomized clinical trial. JAMA. 2015 Feb 3;313(5):471-82. doi: 10.1001/jama.2015.12.
PubMed 25647203Cinat ME, Wallace WC, Nastanski F, West J, Sloan S, Ocariz J, Wilson SE. Improved survival following massive transfusion in patients who have undergone trauma. Arch Surg. 1999 Sep;134(9):964-8; discussion 968-70. doi: 10.1001/archsurg.134.9.964.
PubMed 10487591McDaniel LM, Etchill EW, Raval JS, Neal MD. State of the art: massive transfusion. Transfus Med. 2014 Jun;24(3):138-44. doi: 10.1111/tme.12125.
PubMed 24889805Hakala P, Hiippala S, Syrjala M, Randell T. Massive blood transfusion exceeding 50 units of plasma poor red cells or whole blood: the survival rate and the occurrence of leukopenia and acidosis. Injury. 1999 Nov;30(9):619-22. doi: 10.1016/s0020-1383(99)00166-7.
PubMed 10707230Giancarelli A, Birrer KL, Alban RF, Hobbs BP, Liu-DeRyke X. Hypocalcemia in trauma patients receiving massive transfusion. J Surg Res. 2016 May 1;202(1):182-7. doi: 10.1016/j.jss.2015.12.036. Epub 2015 Dec 30.
PubMed 27083965Moore FA, Moore EE, Sauaia A. Blood transfusion. An independent risk factor for postinjury multiple organ failure. Arch Surg. 1997 Jun;132(6):620-4; discussion 624-5.
PubMed 9197854Johnson JL, Moore EE, Kashuk JL, Banerjee A, Cothren CC, Biffl WL, Sauaia A. Effect of blood products transfusion on the development of postinjury multiple organ failure. Arch Surg. 2010 Oct;145(10):973-7. doi: 10.1001/archsurg.2010.216.
PubMed 20956766Malone DL, Dunne J, Tracy JK, Putnam AT, Scalea TM, Napolitano LM. Blood transfusion, independent of shock severity, is associated with worse outcome in trauma. J Trauma. 2003 May;54(5):898-905; discussion 905-7. doi: 10.1097/01.TA.0000060261.10597.5C.
PubMed 12777902Charles A, Shaikh AA, Walters M, Huehl S, Pomerantz R. Blood transfusion is an independent predictor of mortality after blunt trauma. Am Surg. 2007 Jan;73(1):1-5. doi: 10.1177/000313480707300101.
PubMed 17249446Mitra B, O'Reilly G, Cameron PA, Zatta A, Gruen RL. Effectiveness of massive transfusion protocols on mortality in trauma: a systematic review and meta-analysis. ANZ J Surg. 2013 Dec;83(12):918-23. doi: 10.1111/ans.12417. Epub 2013 Oct 21.
PubMed 24147731Ellingson KD, Sapiano MRP, Haass KA, Savinkina AA, Baker ML, Chung KW, Henry RA, Berger JJ, Kuehnert MJ, Basavaraju SV. Continued decline in blood collection and transfusion in the United States-2015. Transfusion. 2017 Jun;57 Suppl 2(Suppl 2):1588-1598. doi: 10.1111/trf.14165.
PubMed 28591469Vaslef SN, Knudsen NW, Neligan PJ, Sebastian MW. Massive transfusion exceeding 50 units of blood products in trauma patients. J Trauma. 2002 Aug;53(2):291-5; discussion 295-6. doi: 10.1097/00005373-200208000-00017.
PubMed 12169936Toner RW, Pizzi L, Leas B, Ballas SK, Quigley A, Goldfarb NI. Costs to hospitals of acquiring and processing blood in the US: a survey of hospital-based blood banks and transfusion services. Appl Health Econ Health Policy. 2011;9(1):29-37. doi: 10.2165/11530740-000000000-00000.
PubMed 21174480
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- At What Point is Blood Transfusion Futile in Trauma?: A Retrospective Study of Ultra Massive Transfusion Protocol in Adult Trauma Patients Undergoing Surgery Within 24 Hours and Effects on Mortality and Clinical Outcomes
- ClinicalTrials.gov ID
- NCT04866953
- Acronym / sponsor ID
- APP-21-02050
- Conditions
- Trauma, Blood Transfusion Complication, Death
- Keywords
- trauma, massive transfusion protocol, ultra massive transfusion protocol, mortality, outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- University of California, Irvine, University of California, Davis, University of Texas, University of Miami, University of Chicago, Medical College of Wisconsin, Tulane University School of Medicine, University of Arkansas
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 30 Apr 2021 (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.
The purpose of this study is to determine the effects of ultraMTP (>/=30 units pRBC within 24 hours) in trauma patients on mortality and secondary outcomes. The aim is to determine if there is a set number of pRBC units transfused in adult trauma patients undergoing surgery within 24 hours, after which mortality is inevitable and further transfusions are futile.
Detailed description
Rationale: To determine if there is a set number of pRBC units transfused in adult trauma patients undergoing surgery within 24 hours, after which mortality is inevitable and further transfusions are futile.
Intervention: Blood transfusions administered to adult trauma patients undergoing surgery within 24 hours of admission.
Objectives/Purpose: The main objective of this study is to examine the outcomes associated with large volume transfusions at U.S. level I trauma centers in adult trauma patients undergoing surgery within 24 hours of admission. The investigators aim to determine the mortality rate associated with ultraMTP (defined as >/= 30 units pRBC within 24 hours), and the effects of ultraMTP on secondary outcomes. The investigators would also like to compare outcomes among patients who receive various amounts of pRBC units within 24 hours. The information learned through this study will aid in determining whether there is a threshold transfusion amount, after which outcomes significantly worsen, and resuscitation efforts are futile and should cease, in order to save hospital resources, time, and costs.
Study Population/Sample Characteristics: Adult trauma patients requiring surgery within 24 hours of admission who receive blood products.
Study Methodology: This is a multicenter, retrospective observational study.
Study Endpoints/Outcomes:
- Primary outcome: 24-hour mortality (from the time of admission until 24 hours)
- Secondary outcomes: 1. ICU length of stay (LOS); 2. hospital LOS; 3. MV days; 4. Complications; 5. Multiple organ system failure; 6. in hospital mortality; 7. 30-day mortality; 8. discharge disposition.
Statistics/Analysis Plans:
The investigators will construct a logistic regression prediction model to 1) find the cut point classifications for pRBC units that optimize model prediction and 2) find additional variables that improve the predictive ability of our model. Previous studies on pRBC units and mortality have used different category cut points for pRBC units. The investigators will examine the functional form of pRBC units in its relationship with mortality to determine if there is a "plateau" effect of increasing pRBC units on mortality. The investigators will use this information to guide the classification of pRBC unit categories, comparing AIC values from several models with differing pRBC category classification cut off points to determine which of these are most highly associated with mortality. Using these categories, the investigators will then construct the prediction model, using the variables defined in Section 12. Interactions between these candidate predictors variables and pRBC units will additionally be considered. Model validation will be performed using k-folds cross-validation. Model performance will be evaluated by examining discriminative ability (area under ROC curve), calibration metrics, and optimism.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| <30 units PRBC | – | Other: Blood transfusionPatients who underwent surgery within 24 hours of admission and received less than 30 units of pRBC within 24 hours. |
| >/=30 units PRBC | – | Other: Blood transfusionPatients who underwent surgery within 24 hours of admission and received >/=30 units of pRBC within 24 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult trauma patients who underwent surgery within the first 24 hours of admission, who received blood products in the first 24 hours.
Key inclusion criteria (4 listed)
- >/= 18 years old
- trauma patient
- undergoing surgery within first 24 hours of admission
- received blood products within 24 hours of admission
Key exclusion criteria (3 listed)
- <18-years-old
- no surgery within the first 24 hours
- did not receive blood products within the first 24 hours
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 |
|---|---|---|
| Blood transfusionNumber of units of blood received within 24 hours of admission | Other | <30 units PRBC, >/=30 units PRBC |
Primary outcome
24-hour mortality
Time frame: 24 hours
24-hour mortality (yes/no)
8 secondary outcomes
ICU length of stay
Time frame: through study completion, an average of 1 year
hospital length of stay
Time frame: through study completion, an average of 1 year
mechanical ventilator days
Time frame: through study completion, an average of 1 year
complications
Time frame: through study completion, an average of 1 year
Multiple organ system failure
Time frame: through study completion, an average of 1 year
In-hospital mortality
Time frame: through study completion, an average of 1 year
30-day mortality
Time frame: 30 days
discharge disposition
Time frame: through study completion, an average of 1 year
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 5 Mar 2024.
- Results publication: PubMed 30747681Yu AJ, Inaba K, Biswas S, de Leon LA, Wong M, Benjamin E, Lam L, Demetriades D. Supermassive Transfusion: A 15-Year Single Center Experience and Outcomes. Am Surg. 2018 Oct 1;84(10):1617-1621.
- Results publication: PubMed 32955420Consunji R, Elseed A, El-Menyar A, Sathian B, Rizoli S, Al-Thani H, Peralta R. The effect of massive transfusion protocol implementation on the survival of trauma patients: a systematic review and meta-analysis. Blood Transfus. 2020 Nov;18(6):434-445. doi: 10.2450/2020.0065-20. Epub 2020 Sep 18.
- Results publication: PubMed 25647203Holcomb JB, Tilley BC, Baraniuk S, Fox EE, Wade CE, Podbielski JM, del Junco DJ, Brasel KJ, Bulger EM, Callcut RA, Cohen MJ, Cotton BA, Fabian TC, Inaba K, Kerby JD, Muskat P, O'Keeffe T, Rizoli S, Robinson BR, Scalea TM, Schreiber MA, Stein DM, Weinberg JA, Callum JL, Hess JR, Matijevic N, Miller CN, Pittet JF, Hoyt DB, Pearson GD, Leroux B, van Belle G; PROPPR Study Group. Transfusion of plasma, platelets, and red blood cells in a 1:1:1 vs a 1:1:2 ratio and mortality in patients with severe trauma: the PROPPR randomized clinical trial. JAMA. 2015 Feb 3;313(5):471-82. doi: 10.1001/jama.2015.12.
- Results publication: PubMed 10487591Cinat ME, Wallace WC, Nastanski F, West J, Sloan S, Ocariz J, Wilson SE. Improved survival following massive transfusion in patients who have undergone trauma. Arch Surg. 1999 Sep;134(9):964-8; discussion 968-70. doi: 10.1001/archsurg.134.9.964.
- Results publication: PubMed 24889805McDaniel LM, Etchill EW, Raval JS, Neal MD. State of the art: massive transfusion. Transfus Med. 2014 Jun;24(3):138-44. doi: 10.1111/tme.12125.
- Results publication: PubMed 10707230Hakala P, Hiippala S, Syrjala M, Randell T. Massive blood transfusion exceeding 50 units of plasma poor red cells or whole blood: the survival rate and the occurrence of leukopenia and acidosis. Injury. 1999 Nov;30(9):619-22. doi: 10.1016/s0020-1383(99)00166-7.
- Results publication: PubMed 27083965Giancarelli A, Birrer KL, Alban RF, Hobbs BP, Liu-DeRyke X. Hypocalcemia in trauma patients receiving massive transfusion. J Surg Res. 2016 May 1;202(1):182-7. doi: 10.1016/j.jss.2015.12.036. Epub 2015 Dec 30.
- Results publication: PubMed 9197854Moore FA, Moore EE, Sauaia A. Blood transfusion. An independent risk factor for postinjury multiple organ failure. Arch Surg. 1997 Jun;132(6):620-4; discussion 624-5.
- Results publication: PubMed 20956766Johnson JL, Moore EE, Kashuk JL, Banerjee A, Cothren CC, Biffl WL, Sauaia A. Effect of blood products transfusion on the development of postinjury multiple organ failure. Arch Surg. 2010 Oct;145(10):973-7. doi: 10.1001/archsurg.2010.216.
- Results publication: PubMed 12777902Malone DL, Dunne J, Tracy JK, Putnam AT, Scalea TM, Napolitano LM. Blood transfusion, independent of shock severity, is associated with worse outcome in trauma. J Trauma. 2003 May;54(5):898-905; discussion 905-7. doi: 10.1097/01.TA.0000060261.10597.5C.
- Results publication: PubMed 17249446Charles A, Shaikh AA, Walters M, Huehl S, Pomerantz R. Blood transfusion is an independent predictor of mortality after blunt trauma. Am Surg. 2007 Jan;73(1):1-5. doi: 10.1177/000313480707300101.
- Results publication: PubMed 24147731Mitra B, O'Reilly G, Cameron PA, Zatta A, Gruen RL. Effectiveness of massive transfusion protocols on mortality in trauma: a systematic review and meta-analysis. ANZ J Surg. 2013 Dec;83(12):918-23. doi: 10.1111/ans.12417. Epub 2013 Oct 21.
- 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.
Catherine M Kuza, MD principal investigator
University of Southern California
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 Trauma and Blood Transfusion Complication, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 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 5 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 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
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?
24-hour mortality (time frame: 24 hours). 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 NCT04866953, which also lists 23 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 5 Mar 2024.