Liver Cirrhosis With Acute DecompensationPROTECT-CIRRNCT07437755
Thrombelastometry-guided Blood Component Administration Versus Standard of Care in Patients With Decompensated Liver Cirrhosis Undergoing Invasive Procedures
A study testing Blood Products transfusion in people with Liver Cirrhosis With Acute Decompensation, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
Patients with liver cirrhosis have historically received prophylactic transfusions before invasive procedures with high risk of bleeding. The optimal method for establishing the need of blood transfusion before invasive procedures in cirrhotic patients has not been determined yet, and there are not enough scientific… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis With Acute Decompensation
- What is being tested?
- Blood Products transfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteRomania
- Study dates
- 1 Jun 2025to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- diagnosed with decompensated liver cirrhosis of any etiology
- planned for a high risk of bleeding invasive procedure
- coagulopathic based on conventional coagulation tests and considered for pre-procedural blood component prophylaxis
- able and willing to provide informed consent
Who cannot join
- acute liver failure
- current use of anticoagulant treatment
- patients on antiplatelet aggregation agents
- patients who have received FFP, platelet transfusion, cryoprecipitate in the week prior to the procedure
- patients with stage 4 or 5 chronic kidney disease or patients receiving renal replacement therapy
- sepsis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romania1 site, 1 recruiting
- Recruiting
Institute of Gastroenterology and Hepatology
Iași, Iaşi, 700111
Cristina Muzica, Lecturer, MD, PhD, +40747521793, lungu.chirstina@yahoo.com
gilda_iri25@yahoo.com
About this study
Official title: Thrombelastometry-guided Blood Component Administration Versus Standard of Care in Patients With Decompensated Liver Cirrhosis Undergoing High Risk of Bleeding Invasive Procedures
Patients with liver cirrhosis have historically received prophylactic transfusions before invasive procedures with high risk of bleeding. The optimal method for establishing the need of blood transfusion before invasive procedures in cirrhotic patients has not been determined yet, and there are not enough scientific data to warrant empirical transfusion. In many surgical and trauma-related contexts, viscoelastic tests, like Rotational Thromboelastometry (ROTEM), offer a comprehensive assessment of hemostasis, and it has been demonstrated to predict bleeding risk more accurately than traditional coagulation tests. The aim of this project is to evaluate the efficacy of a ROTEM-based algorithm in managing the administration of prophylactic blood components to patients diagnosed with decompensated liver cirrhosis undergoing invasive high risk of bleeding procedures. The investigators hypothesized that ROTEM-based decision-making will lead to a reduction in pre-procedural blood component usage, particularly fresh frozen plasma (FFP), compared with standard of care, whilst maintaining optimal clinical outcomes. The investigators will perform a prospective, single-center, randomized controlled clinical trial in a tertiary university hospital in Romania, comparing ROTEM-guided prophylactic blood component administration to standard of care in patients with decompensated cirrhosis and coagulopathy undergoing invasive procedures. Inclusion criteria: adults (aged 18 years or older) admitted with cirrhosis and an indication for high risk of bleeding invasive procedure defined as: transjugular liver biopsy, transjugular intrahepatic portosystemic shunt, endoscopic retrograde cholangio-pancreatography with sphincterotomy, endoscopic polypectomy of polyps more than 1 cm, variceal banding and complex dental extraction. The primary safety endpoint will be the incidence of major bleeding. Secondary endpoints will be the proportion of blood products transfusion, hospital length of stay, in-hospital and 28-day mortality, incidence of minor bleeding, transfusion related adverse reactions, and cost analysis.
Read the detailed description
This project will compare two blood transfusion protocols (coagulogram-based and thromboelastometry-based) prior to high risk of bleeding procedures in patients with cirrhosis. The investigators hypothesized that thromboelastometry-guided transfusion protocols are safe and would decrease the need of blood products transfusion compared to an ordinary coagulogram-based protocol in patients with decompensated cirrhosis receiving high risk of bleeding procedures.
- Being tested
- Blood Products transfusion
- Keywords
- ROTEM, decompensated liver cirrhosis, bleeding risk, blood product transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Products transfusionProcedure or surgery
Blood Products transfusion
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | Takes into account the SCTs -PT/INR, platelet count and serum fibrinogen levels to guide transfusion prior to high risk of bleeding invasive procedure. If INR ≤1.8, platelet count ≥50,000/mm3 and serum fibrinogen ≥120 mg/dL, no transfusion is indicated. Otherwise, if INR >1.8, FFP is transfused at 10 mL per kg of body weight; and/or if platelet count <50,000/mm3, 1 unit per 10 kg of body weight of platelets (up to 10 units) is transfused; and/or if serum fibrinogen <120 mg/dL, 1 unit per 10 kg of body weight of cryoprecipitate is transfused (up to 10 units). Receives: Procedure: Blood Products transfusion |
| ROTEM-based | Experimental | The thromboelastometry-based transfusion protocol uses EXTEM and FIBTEM. No transfusion is necessary when CT-EXTEM is ≤80 s and A10-EXTEM is ≥40 mm. For patients in whom CT-EXTEM is >80 s, transfusion of 10 mL per kg of body weight of FFP will be performed. If the patient presents an A10-EXTEM <40 mm, the investigators will further evaluate the A10-FIBTEM. If A10-FIBTEM is ≥10 mm (indicating adequate fibrinogen function), platelet units (1 unit per 10 kg of body weight; maximum 10 units) will be transfused. Otherwise, if A10-FIBTEM is <10 mm (indicating fibrinogen deficiency), cryoprecipitate (1 unit per 10 kg of body weight; maximum 10 units) will be transfused. Receives: Procedure: Blood Products transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients transfused with any blood product
This measure represents the percentage of patients within the study population who received at least one transfusion of any blood component during study period. It is calculated by dividing the number of patients who were administered one or more units of a blood product by the total number of eligible patients in the cohort, and multiplying by 100 to express the result as a percentage. Blood products include platelets, fresh frozen plasma, or cryoprecipitate.
Measured: From the enrollment to 30 days after the procedure
The incidence of major bleeding within the first 24 h
The incidence of major bleeding within the first 24 h after high risk of bleeding invasive procedures. It quantifies early clinically significant hemorrhagic complications and is typically expressed as a percentage or rate.
For the purposes of this measure, major bleeding is defined according to standardized clinical criteria. Commonly applied definitions include adapted criteria from the International Society on Thrombosis and Haemostasis (ISTH) or similar consensus frameworks. A bleeding event is classified as major if it meets one or more of the following conditions: fatal bleeding, symptomatic bleeding in a critical area or organ (intracranial, intraspinal, intraocular, retroperitoneal, pericardial, or intramuscular with compartment syndrome), a decrease in hemoglobin of ≥2 g/dL (≥20 g/L) within 24 hours attributable to bleeding
, transfusion of ≥2 units of packed red blood cells due to acute blood loss, bleeding requiring urgent procedural or surgical intervention.
Measured: From the enrollment to 30 days after the procedure
Secondary outcomes (4)
The incidence of acute transfusion-related adverse events
This measure represents the proportion of transfusion episodes that are complicated by an acute transfusion-related adverse event occurring during or within 24 hours after the administration of a blood component. It will be expressed as a percentage and it will be calculated by dividing the number of transfusion episodes complicated by at least one qualifying acute adverse event by the total number of transfusion episodes administered during the study period. An acute transfusion-related adverse event is defined as a new clinical sign or symptom occurring during transfusion or within 24 hours after completion, for which a causal relationship to the transfused blood component is suspected, probable, or definite. The investigators will evaluate transfusion-associated cardiac overload, acute hemolytic transfusion reactions, anaphylactic reactions, febrile non-hemolytic reactions and urticarial reactions.
Measured: From enrollment to 30 days after the procedure
The hospital length of stay
The investigators will evaluate the hospital length of stay in both study arms
Measured: From enrollment to 30 days after the procedure
In hospital mortality
This measure represents the proportion of patients who die from any cause during hospital admission. It captures all-cause mortality occurring between the time of hospital admission and discharge and is typically expressed as a percentage of the total eligible patient population.
Measured: From the enrollment to discharge or death
30-days mortality
This measure represents the proportion of patients who die from any cause within 30 days of a defined index event. The index event will be high risk of bleeding invasive procedure. The outcome will be expressed as a percentage and will reflect short-term mortality risk beyond the inpatient setting. 30-day mortality is defined as death from any cause occurring within 30 calendar days of the high risk of bleeding invasive procedure regardless of whether the patient is hospitalized, discharged, or transferred at the time of death. Mortality status will be evaluated through telephone follow-up with patients or family members
Measured: From date of randomization until the end of the study or the date of death from any cause, whichever came first, assessed up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Jun 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Liver Cirrhosis With Acute DecompensationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grigore T. Popa University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irina Girleanu, Grigore T. Popa University of Medicine and Pharmacy
- Investigators
- Irina Girleanu, Associated Professor, Principal investigator, Grigore T. Popa University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437755
- Sponsor's protocol ID
- 13536
- Acronym
- PROTECT-CIRR
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Northup PG, Garcia-Pagan JC, Garcia-Tsao G, Intagliata NM, Superina RA, Roberts LN, Lisman T, Valla DC. Vascular Liver Disorders, Portal Vein Thrombosis, and Procedural Bleeding in Patients With Liver Disease: 2020 Practice Guidance by the American Association for the Study of Liver Diseases. Hepatology. 2021 Jan;73(1):366-413. doi: 10.1002/hep.31646. Epub 2021 Jan 20. No abstract available.
PubMed 33219529Riescher-Tuczkiewicz A, Caldwell SH, Kamath PS, Villa E, Rautou PE; Bleeding in liver diseases investigatorsdagger; Bleeding in liver diseases investigators. Expert opinion on bleeding risk from invasive procedures in cirrhosis. JHEP Rep. 2023 Dec 19;6(3):100986. doi: 10.1016/j.jhepr.2023.100986. eCollection 2024 Mar.
PubMed 38384669Tangcheewinsirikul N, Moonla C, Uaprasert N, Pittayanon R, Rojnuckarin P. Viscoelastometric versus standard coagulation tests to guide periprocedural transfusion in adults with cirrhosis: A meta-analysis of randomized controlled trials. Vox Sang. 2022 Apr;117(4):553-561. doi: 10.1111/vox.13225. Epub 2021 Dec 15.
PubMed 34911140Intagliata NM, Davitkov P, Allen AM, Falck-Ytter YT, Stine JG. AGA Technical Review on Coagulation in Cirrhosis. Gastroenterology. 2021 Nov;161(5):1630-1656. doi: 10.1053/j.gastro.2021.09.004. Epub 2021 Sep 25. No abstract available.
PubMed 34579937European Association for the Study of the Liver. EASL Clinical Practice Guidelines on prevention and management of bleeding and thrombosis in patients with cirrhosis. J Hepatol. 2022 May;76(5):1151-1184. doi: 10.1016/j.jhep.2021.09.003. Epub 2022 Mar 15.
PubMed 35300861
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombelastometry-guided Blood Component Administration Versus Standard of Care in Patients With Decompensated Liver Cirrhosis Undergoing High Risk of Bleeding Invasive Procedures
- ClinicalTrials.gov ID
- NCT07437755
- Acronym / sponsor ID
- PROTECT-CIRR / 13536
- Keywords
- ROTEM, decompensated liver cirrhosis, bleeding risk, blood product transfusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Grigore T. Popa University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 27 Feb 2026 (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.
Patients with liver cirrhosis have historically received prophylactic transfusions before invasive procedures with high risk of bleeding. The optimal method for establishing the need of blood transfusion before invasive procedures in cirrhotic patients has not been determined yet, and there are not enough scientific data to warrant empirical transfusion. In many surgical and trauma-related contexts, viscoelastic tests, like Rotational Thromboelastometry (ROTEM), offer a comprehensive assessment of hemostasis, and it has been demonstrated to predict bleeding risk more accurately than traditional coagulation tests. The aim of this project is to evaluate the efficacy of a ROTEM-based algorithm in managing the administration of prophylactic blood components to patients diagnosed with decompensated liver cirrhosis undergoing invasive high risk of bleeding procedures. The investigators hypothesized that ROTEM-based decision-making will lead to a reduction in pre-procedural blood component usage, particularly fresh frozen plasma (FFP), compared with standard of care, whilst maintaining optimal clinical outcomes. The investigators will perform a prospective, single-center, randomized controlled clinical trial in a tertiary university hospital in Romania, comparing ROTEM-guided prophylactic blood component administration to standard of care in patients with decompensated cirrhosis and coagulopathy undergoing invasive procedures. Inclusion criteria: adults (aged 18 years or older) admitted with cirrhosis and an indication for high risk of bleeding invasive procedure defined as: transjugular liver biopsy, transjugular intrahepatic portosystemic shunt, endoscopic retrograde cholangio-pancreatography with sphincterotomy, endoscopic polypectomy of polyps more than 1 cm, variceal banding and complex dental extraction. The primary safety endpoint will be the incidence of major bleeding. Secondary endpoints will be the proportion of blood products transfusion, hospital length of stay, in-hospital and 28-day mortality, incidence of minor bleeding, transfusion related adverse reactions, and cost analysis.
Detailed description
This project will compare two blood transfusion protocols (coagulogram-based and thromboelastometry-based) prior to high risk of bleeding procedures in patients with cirrhosis. The investigators hypothesized that thromboelastometry-guided transfusion protocols are safe and would decrease the need of blood products transfusion compared to an ordinary coagulogram-based protocol in patients with decompensated cirrhosis receiving high risk of bleeding procedures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Procedure: Blood Products transfusionTakes into account the SCTs -PT/INR, platelet count and serum fibrinogen levels to guide transfusion prior to high risk of bleeding invasive procedure. If INR ≤1.8, platelet count ≥50,000/mm3 and serum fibrinogen ≥120 mg/dL, no transfusion is indicated. Otherwise, if INR >1.8, FFP is transfused at 10 mL per kg of body weight; and/or if platelet count <50,000/mm3, 1 unit per 10 kg of body weight of platelets (up to 10 units) is transfused; and/or if serum fibrinogen <120 mg/dL, 1 unit per 10 kg of body weight of cryoprecipitate is transfused (up to 10 units). |
| ROTEM-based | Experimental | Procedure: Blood Products transfusionThe thromboelastometry-based transfusion protocol uses EXTEM and FIBTEM. No transfusion is necessary when CT-EXTEM is ≤80 s and A10-EXTEM is ≥40 mm. For patients in whom CT-EXTEM is >80 s, transfusion of 10 mL per kg of body weight of FFP will be performed. If the patient presents an A10-EXTEM <40 mm, the investigators will further evaluate the A10-FIBTEM. If A10-FIBTEM is ≥10 mm (indicating adequate fibrinogen function), platelet units (1 unit per 10 kg of body weight; maximum 10 units) will be transfused. Otherwise, if A10-FIBTEM is <10 mm (indicating fibrinogen deficiency), cryoprecipitate (1 unit per 10 kg of body weight; maximum 10 units) will be transfused. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosed with decompensated liver cirrhosis of any etiology
- planned for a high risk of bleeding invasive procedure
- coagulopathic based on conventional coagulation tests and considered for pre-procedural blood component prophylaxis
- able and willing to provide informed consent
Key exclusion criteria (6 listed)
- acute liver failure
- current use of anticoagulant treatment
- patients on antiplatelet aggregation agents
- patients who have received FFP, platelet transfusion, cryoprecipitate in the week prior to the procedure
- patients with stage 4 or 5 chronic kidney disease or patients receiving renal replacement therapy
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 Products transfusionBlood Products transfusion | Procedure or surgery | ROTEM-based, Standard of care |
Primary outcome
The proportion of patients transfused with any blood product
Time frame: From the enrollment to 30 days after the procedure
This measure represents the percentage of patients within the study population who received at least one transfusion of any blood component during study period. It is calculated by dividing the number of patients who were administered one or more units of a blood product by the total number of eligible patients in the cohort, and multiplying by 100 to express the result as a percentage. Blood products include platelets, fresh frozen plasma, or cryoprecipitate.
The incidence of major bleeding within the first 24 h
Time frame: From the enrollment to 30 days after the procedure
The incidence of major bleeding within the first 24 h after high risk of bleeding invasive procedures. It quantifies early clinically significant hemorrhagic complications and is typically expressed as a percentage or rate. For the purposes of this measure, major bleeding is defined according to standardized clinical criteria. Commonly applied definitions include adapted criteria from the International Society on Thrombosis and Haemostasis (ISTH) or similar consensus frameworks. A bleeding event is classified as major if it meets one or more of the following conditions: fatal bleeding, symptomatic bleeding in a critical area or organ (intracranial, intraspinal, intraocular, retroperitoneal, pericardial, or intramuscular with compartment syndrome), a decrease in hemoglobin of ≥2 g/dL (≥20 g/L) within 24 hours attributable to bleeding , transfusion of ≥2 units of packed red blood cells due to acute blood loss, bleeding requiring urgent procedural or surgical intervention.
4 secondary outcomes
The incidence of acute transfusion-related adverse events
Time frame: From enrollment to 30 days after the procedure
The hospital length of stay
Time frame: From enrollment to 30 days after the procedure
In hospital mortality
Time frame: From the enrollment to discharge or death
30-days mortality
Time frame: From date of randomization until the end of the study or the date of death from any cause, whichever came first, assessed up to 30 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Background: PubMed 33219529Northup PG, Garcia-Pagan JC, Garcia-Tsao G, Intagliata NM, Superina RA, Roberts LN, Lisman T, Valla DC. Vascular Liver Disorders, Portal Vein Thrombosis, and Procedural Bleeding in Patients With Liver Disease: 2020 Practice Guidance by the American Association for the Study of Liver Diseases. Hepatology. 2021 Jan;73(1):366-413. doi: 10.1002/hep.31646. Epub 2021 Jan 20. No abstract available.
- Background: PubMed 38384669Riescher-Tuczkiewicz A, Caldwell SH, Kamath PS, Villa E, Rautou PE; Bleeding in liver diseases investigatorsdagger; Bleeding in liver diseases investigators. Expert opinion on bleeding risk from invasive procedures in cirrhosis. JHEP Rep. 2023 Dec 19;6(3):100986. doi: 10.1016/j.jhepr.2023.100986. eCollection 2024 Mar.
- Background: PubMed 34911140Tangcheewinsirikul N, Moonla C, Uaprasert N, Pittayanon R, Rojnuckarin P. Viscoelastometric versus standard coagulation tests to guide periprocedural transfusion in adults with cirrhosis: A meta-analysis of randomized controlled trials. Vox Sang. 2022 Apr;117(4):553-561. doi: 10.1111/vox.13225. Epub 2021 Dec 15.
- Background: PubMed 34579937Intagliata NM, Davitkov P, Allen AM, Falck-Ytter YT, Stine JG. AGA Technical Review on Coagulation in Cirrhosis. Gastroenterology. 2021 Nov;161(5):1630-1656. doi: 10.1053/j.gastro.2021.09.004. Epub 2021 Sep 25. No abstract available.
- Background: PubMed 35300861European Association for the Study of the Liver. EASL Clinical Practice Guidelines on prevention and management of bleeding and thrombosis in patients with cirrhosis. J Hepatol. 2022 May;76(5):1151-1184. doi: 10.1016/j.jhep.2021.09.003. Epub 2022 Mar 15.
- 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.
Irina Girleanu, Associated Professor principal investigator
Grigore T. Popa University of Medicine and Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Products transfusion in people with Liver Cirrhosis With Acute Decompensation, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
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 6 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: looking for participants now, as of the sponsor's last update on 27 Feb 2026. 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 Romania. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Irina Girleanu, Associated Professor (+40762278575, gilda_iri25@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients transfused with any blood product (time frame: From the enrollment to 30 days after the procedure). The study lists 2 primary outcomes in all. 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 NCT07437755, which also lists 5 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 27 Feb 2026.