Cardiac SurgeryBLOOCOSTNCT04141631
Transfusion Savings in Heart Surgery: Impact of Individual Strategy by Erythropoietin and Metabolic Adjustment (ScvO2)
A study testing EPO (600UI/Kg, sub-cutaneous) and Ferric Carboxymaltose (FCM) (20 mg/kg in 250 mL of saline solution 0.9% over 15 min) in people with Cardiac Surgery and Transfusion, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Preoperative anemia, bleeding and transfusions have been recognized as a "Deadly triad" in cardiac surgery associated with an increased morbidity,mortality, and costs related. Thus strategies to reduce unnecessary RBC transfusions and to optimize preoperative anemia must be developed .The study evaluate an individual… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardiac Surgery, Transfusion, Perioperative Anemia
- What is being tested?
- EPO (600UI/Kg, sub-cutaneous) and Ferric Carboxymaltose (FCM) (20 mg/kg in 250 mL of saline solution 0.9% over 15 min)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jan 2020to 15 Jun 2022
- Phase
- Interventional
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled Cardiac surgery for more than 24 hours
- High risk of perioperative transfusion defined by a TRUST Score ≥ 3
- Veno-Venous catheter in Superior vena cava territory
- Patient Affiliate or beneficiary of social security
- Collection on free, informed and written consent
Who cannot join
- EPO and FCM contraindication
- Patients already treated by EPO at the time of inclusion
- Non controlled Infectious endocarditis defined by ESC guidelines 2015
- Patients including in an other research
- Patients whose physical and/or psychological health is severely impaired and who, according to the investigator, may affect the participant's compliance with the study.
- Patients deprived from his rights (guardianship or tutelage measure)
- Patients who refuses to sign the consent
- pregnant or lactating woman
Trial locations and contacts
1 site in 1 country.
France1 site
DEpartement d'anesthésie et réanimation D - Arnaud de Villeneuve
Montpellier, 34295
About this study
Official title: Patient Blood Management in Cardiac Surgery by Erythropoietin, Ferric Carboxymaltose and Metabolic Adjustment (ScvO2): A Randomized Controlled Study
Preoperative anemia, bleeding and transfusions have been recognized as a "Deadly triad" in cardiac surgery associated with an increased morbidity,mortality, and costs related. Thus strategies to reduce unnecessary RBC transfusions and to optimize preoperative anemia must be developed .The study evaluate an individual blood conservation strategy based on patient blood management bundles in cardiac surgery patients: optimisation perioperative hemoglobin level by erythropoietin and ferric carboxymaltose (Ferinject) associated with the use of ScV02 to guide perioperative erythrocyte transfusion.
Read the detailed description
Preoperative anemia is the most common haematological abnormalities in cardiac surgery affecting 20 to 40% of patients and is becoming increasingly prevalent due to an ageing population with more chronic diseases.Preoperative anemia is independently associated with increased risk of adverse outcome following cardiac surgery but also implies blood transfusions which, associated with anemia, increase significantly perioperative cardiac morbidity and mortality. Therefore, strategies of blood conservation to optimize anemia and to minimize transfusion have been developped in the concept of the Blood Patient Management (BPM). To correct anemia, intravenous iron has been shown to be an effective treatment with increase hemoglobin (Hb) level in the perioperative period. It is now established that intravenous iron, as ferric carboxymaltose (Ferinject) is better tolerated compared to oral supplementation with better stimulation of erythropoiesis and,consequently, higher Hb levels. Based on promising results in the orthopedic surgery patients, the use of recombinant human erythropoietin (EPO) has also been proposed in cardiac surgery. Secondly, because even one red blood cells products (RBC) compromises postoperative outcome, guidelines suggest to adopt restrictive threshold of Hb levels to decide RBC transfusion. However, beyond the fact that RBC transfusion correct Hb level, the final goal of blood transfusion is to improve oxygen delivery to hypoxemic tissue. In this respect, the relevance of the use of a Hb threshold to guide transfusion have been questioned. Venous oxygen saturation (SvO2) and ScvO2 (central oxygen venous saturation), global parameters of tissue oxygenation, in stable hemodynamic and respiratory conditions, may be an relevant marker of anemia tolerance. Recently, the investigators demonstrated the lack of benefit in terms of ScvO2 increase during erythrocyte transfusion if ScvO2 was > 65%.
In order to reduce exposure to transfusion, the management of anemia with EPO and perioperative intravenous FCM associated with the use of ScvO2 could be interesting to both improve Hb levels and reduce RBC transfusion.
- Conditions
- Cardiac Surgery, Transfusion, Perioperative Anemia
- Being tested
- EPO (600UI/Kg, sub-cutaneous) and Ferric Carboxymaltose (FCM) (20 mg/kg in 250 mL of saline solution 0.9% over 15 min)
- Keywords
- Perioperative Erythropoietin, Perioperative Iron, ScVO2, Patient blood Management, Blood Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPO (600UI/Kg, sub-cutaneous) and Ferric Carboxymaltose (FCM) (20 mg/kg in 250 mL of saline solution 0.9% over 15 min)Drug
EPO (600UI/Kg, sub-cutaneous) and Ferric Carboxymaltose (FCM) (20 mg/kg in 250 mL of saline solution 0.9% over 15 min) will be administered if
- Hb < 13g/dL the day before surgery
- Hb ≥ 7g/dL AND ScvO2 > 65% in postoperative ICU stay
Postoperative Transfusion will be guided by ScvO2 values :
if Hb ≤ 8 g/dL AND ScvO2 ≤ 65% or if Hb < 7g/dL independently of ScVO2 value
| Study group | Role | What they receive |
|---|---|---|
| STOP Group | Experimental | EPO (600UI/Kg, sub-cutaneous) and Ferric Carboxymaltose (FCM) (20 mg/kg in 250 mL of saline solution 0.9% over 15 min) will be administered if
* Hb < 13g/dL the day before surgery
* Hb ≥ 7g/dL AND ScvO2 > 65% in postoperative ICU stay
Postoperative Transfusion will be guided by ScvO2 values :
if Hb ≤ 8 g/dL AND ScvO2 ≤ 65% or if Hb < 7g/dL independently of ScVO2 value Receives: Drug: EPO (600UI/Kg, sub-cutaneous) and Ferric Carboxymaltose (FCM) (20 mg/kg in 250 mL of saline solution 0.9% over 15 min) |
| Control Group | No intervention | Only postoperative anemia will be managed: * RBC transfusion will be performed if Hb ≤ 8 g/dL (2017 EACTS/EACTA guidelines) * Iron sucrose administration if Hb > 8g/dL : 2 injections of 200 mg according to Height (+/- 70 Kg) in 250 mL of saline solution 0.9% over 1h30 into 48 h intervals without exceeding a total dose of 15mg/kg. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transfusion incidence at hospital discharge
Number of patients transfused of blood units
Measured: up to Day 28
Secondary outcomes (8)
ICU transfusion incidence
Number of blood units transfused during ICU stay
Measured: at ICU discharge or up to Day 28
total of blood units transfused
number of blood units administered per patient
Measured: up to day 28
Hemoglobin level at surgery discharge and Hemoglobin level at 1 month after discharge from hospital
the last hemoglobin value at surgery discharge and the hemoglobin value at 1 month after discharge from hospital
Measured: at surgery discharge (or at Day 28) and at 1 month after discharge from hospital
The total duration of mechanical ventilation
The total duration of mechanical ventilation in ICU
Measured: at ICU discharge or up to Day 28
length of stay in ICU
numbers of days in ICU
Measured: up to day 28
Length of hospital stay
Length of stay during hospitalization (Between 1 and 28 day)
Measured: at day 28
Incidence of Mortality
Incidence of 28-day mortality
Measured: at day 28
Incidence of postoperative events in ICU
AKI (KDIGO criteria), Cardiac dysfunction (acute heart failure requiring inotrope or extracorporeal life support (ECLS), arrythmia), vascular dysfunction (norepinephrine support without sepsis), respiratory dysfunction (non invasive ventilation devices, secondary intubation,mechanical ventilation more than 12 hours), septic complications (sepsis/septic shock)
Measured: at day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start13 Jan 2020
- Primary completion10 May 2022
- Study completion15 Jun 2022
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 Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141631
- Sponsor's protocol ID
- RECHMPL19_0042
- Acronym
- BLOOCOST
- Status last verified
- May 2026
- First submitted
- 4 Oct 2019
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ranucci M, Baryshnikova E, Castelvecchio S, Pelissero G; Surgical and Clinical Outcome Research (SCORE) Group. Major bleeding, transfusions, and anemia: the deadly triad of cardiac surgery. Ann Thorac Surg. 2013 Aug;96(2):478-85. doi: 10.1016/j.athoracsur.2013.03.015. Epub 2013 May 11.
PubMed 23673069Plicht B, Lind A, Erbel R. [Infective endocarditis : New ESC guidelines 2015]. Internist (Berl). 2016 Jul;57(7):675-90. doi: 10.1007/s00108-016-0086-y. German.
PubMed 27307162Alghamdi AA, Davis A, Brister S, Corey P, Logan A. Development and validation of Transfusion Risk Understanding Scoring Tool (TRUST) to stratify cardiac surgery patients according to their blood transfusion needs. Transfusion. 2006 Jul;46(7):1120-9. doi: 10.1111/j.1537-2995.2006.00860.x.
PubMed 16836558Task Force on Patient Blood Management for Adult Cardiac Surgery of the European Association for Cardio-Thoracic Surgery (EACTS) and the European Association of Cardiothoracic Anaesthesiology (EACTA); Boer C, Meesters MI, Milojevic M, Benedetto U, Bolliger D, von Heymann C, Jeppsson A, Koster A, Osnabrugge RL, Ranucci M, Ravn HB, Vonk ABA, Wahba A, Pagano D. 2017 EACTS/EACTA Guidelines on patient blood management for adult cardiac surgery. J Cardiothorac Vasc Anesth. 2018 Feb;32(1):88-120. doi: 10.1053/j.jvca.2017.06.026. Epub 2017 Sep 30. No abstract available.
PubMed 29029990Saour M, Blin C, Zeroual N, Mourad M, Amico M, Gaudard P, Picot MC, Colson PH. Impact of a bundle of care (intravenous iron, erythropoietin and transfusion metabolic adjustment) on post-operative transfusion incidence in cardiac surgery: a single-centre, randomised, open-label, parallel-group controlled pilot trial. Lancet Reg Health Eur. 2024 Jun 24;43:100966. doi: 10.1016/j.lanepe.2024.100966. eCollection 2024 Aug.
PubMed 39022429
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Blood Management in Cardiac Surgery by Erythropoietin, Ferric Carboxymaltose and Metabolic Adjustment (ScvO2): A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04141631
- Acronym / sponsor ID
- BLOOCOST / RECHMPL19_0042
- Conditions
- Cardiac Surgery, Transfusion, Perioperative Anemia
- Keywords
- Perioperative Erythropoietin, Perioperative Iron, ScVO2, Patient blood Management, Blood Transfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 10 May 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 28 Oct 2019 (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.
Preoperative anemia, bleeding and transfusions have been recognized as a "Deadly triad" in cardiac surgery associated with an increased morbidity,mortality, and costs related. Thus strategies to reduce unnecessary RBC transfusions and to optimize preoperative anemia must be developed .The study evaluate an individual blood conservation strategy based on patient blood management bundles in cardiac surgery patients: optimisation perioperative hemoglobin level by erythropoietin and ferric carboxymaltose (Ferinject) associated with the use of ScV02 to guide perioperative erythrocyte transfusion.
Detailed description
Preoperative anemia is the most common haematological abnormalities in cardiac surgery affecting 20 to 40% of patients and is becoming increasingly prevalent due to an ageing population with more chronic diseases.Preoperative anemia is independently associated with increased risk of adverse outcome following cardiac surgery but also implies blood transfusions which, associated with anemia, increase significantly perioperative cardiac morbidity and mortality. Therefore, strategies of blood conservation to optimize anemia and to minimize transfusion have been developped in the concept of the Blood Patient Management (BPM). To correct anemia, intravenous iron has been shown to be an effective treatment with increase hemoglobin (Hb) level in the perioperative period. It is now established that intravenous iron, as ferric carboxymaltose (Ferinject) is better tolerated compared to oral supplementation with better stimulation of erythropoiesis and,consequently, higher Hb levels. Based on promising results in the orthopedic surgery patients, the use of recombinant human erythropoietin (EPO) has also been proposed in cardiac surgery. Secondly, because even one red blood cells products (RBC) compromises postoperative outcome, guidelines suggest to adopt restrictive threshold of Hb levels to decide RBC transfusion. However, beyond the fact that RBC transfusion correct Hb level, the final goal of blood transfusion is to improve oxygen delivery to hypoxemic tissue. In this respect, the relevance of the use of a Hb threshold to guide transfusion have been questioned. Venous oxygen saturation (SvO2) and ScvO2 (central oxygen venous saturation), global parameters of tissue oxygenation, in stable hemodynamic and respiratory conditions, may be an relevant marker of anemia tolerance. Recently, the investigators demonstrated the lack of benefit in terms of ScvO2 increase during erythrocyte transfusion if ScvO2 was > 65%.
In order to reduce exposure to transfusion, the management of anemia with EPO and perioperative intravenous FCM associated with the use of ScvO2 could be interesting to both improve Hb levels and reduce RBC transfusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STOP Group | Experimental | Drug: EPO (600UI/Kg, sub-cutaneous) and Ferric Carboxymaltose (FCM) (20 mg/kg in 250 mL of saline solution 0.9% over 15 min)EPO (600UI/Kg, sub-cutaneous) and Ferric Carboxymaltose (FCM) (20 mg/kg in 250 mL of saline solution 0.9% over 15 min) will be administered if * Hb < 13g/dL the day before surgery * Hb ≥ 7g/dL AND ScvO2 > 65% in postoperative ICU stay Postoperative Transfusion will be guided by ScvO2 values : if Hb ≤ 8 g/dL AND ScvO2 ≤ 65% or if Hb < 7g/dL independently of ScVO2 value |
| Control Group | No intervention | –Only postoperative anemia will be managed: * RBC transfusion will be performed if Hb ≤ 8 g/dL (2017 EACTS/EACTA guidelines) * Iron sucrose administration if Hb > 8g/dL : 2 injections of 200 mg according to Height (+/- 70 Kg) in 250 mL of saline solution 0.9% over 1h30 into 48 h intervals without exceeding a total dose of 15mg/kg. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Scheduled Cardiac surgery for more than 24 hours
- High risk of perioperative transfusion defined by a TRUST Score ≥ 3
- Veno-Venous catheter in Superior vena cava territory
- Patient Affiliate or beneficiary of social security
- Collection on free, informed and written consent
Key exclusion criteria (8 listed)
- EPO and FCM contraindication
- Patients already treated by EPO at the time of inclusion
- Non controlled Infectious endocarditis defined by ESC guidelines 2015
- Patients including in an other research
- Patients whose physical and/or psychological health is severely impaired and who, according to the investigator, may affect the participant's compliance with the study.
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 |
|---|---|---|
| EPO (600UI/Kg, sub-cutaneous) and Ferric Carboxymaltose (FCM) (20 mg/kg in 250 mL of saline solution 0.9% over 15 min)EPO (600UI/Kg, sub-cutaneous) and Ferric Carboxymaltose (FCM) (20 mg/kg in 250 mL of saline solution 0.9% over 15 min) will be administered if * Hb < 13g/dL the day before surgery * Hb ≥ 7g/dL AND ScvO2 > 65% in postoperative ICU stay Postoperative Transfusion will be guided by ScvO2 values : if Hb ≤ 8 g/dL AND ScvO2 ≤ 65% or if Hb < 7g/dL independently of ScVO2 value | Drug | STOP Group |
Primary outcome
Transfusion incidence at hospital discharge
Time frame: up to Day 28
Number of patients transfused of blood units
8 secondary outcomes
ICU transfusion incidence
Time frame: at ICU discharge or up to Day 28
total of blood units transfused
Time frame: up to day 28
Hemoglobin level at surgery discharge and Hemoglobin level at 1 month after discharge from hospital
Time frame: at surgery discharge (or at Day 28) and at 1 month after discharge from hospital
The total duration of mechanical ventilation
Time frame: at ICU discharge or up to Day 28
length of stay in ICU
Time frame: up to day 28
Length of hospital stay
Time frame: at day 28
Incidence of Mortality
Time frame: at day 28
Incidence of postoperative events in ICU
Time frame: at day 28
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 15 Jun 2026.
- Background: PubMed 23673069Ranucci M, Baryshnikova E, Castelvecchio S, Pelissero G; Surgical and Clinical Outcome Research (SCORE) Group. Major bleeding, transfusions, and anemia: the deadly triad of cardiac surgery. Ann Thorac Surg. 2013 Aug;96(2):478-85. doi: 10.1016/j.athoracsur.2013.03.015. Epub 2013 May 11.
- Background: PubMed 27307162Plicht B, Lind A, Erbel R. [Infective endocarditis : New ESC guidelines 2015]. Internist (Berl). 2016 Jul;57(7):675-90. doi: 10.1007/s00108-016-0086-y. German.
- Background: PubMed 16836558Alghamdi AA, Davis A, Brister S, Corey P, Logan A. Development and validation of Transfusion Risk Understanding Scoring Tool (TRUST) to stratify cardiac surgery patients according to their blood transfusion needs. Transfusion. 2006 Jul;46(7):1120-9. doi: 10.1111/j.1537-2995.2006.00860.x.
- Background: PubMed 29029990Task Force on Patient Blood Management for Adult Cardiac Surgery of the European Association for Cardio-Thoracic Surgery (EACTS) and the European Association of Cardiothoracic Anaesthesiology (EACTA); Boer C, Meesters MI, Milojevic M, Benedetto U, Bolliger D, von Heymann C, Jeppsson A, Koster A, Osnabrugge RL, Ranucci M, Ravn HB, Vonk ABA, Wahba A, Pagano D. 2017 EACTS/EACTA Guidelines on patient blood management for adult cardiac surgery. J Cardiothorac Vasc Anesth. 2018 Feb;32(1):88-120. doi: 10.1053/j.jvca.2017.06.026. Epub 2017 Sep 30. No abstract available.
- Results publication: PubMed 39022429Saour M, Blin C, Zeroual N, Mourad M, Amico M, Gaudard P, Picot MC, Colson PH. Impact of a bundle of care (intravenous iron, erythropoietin and transfusion metabolic adjustment) on post-operative transfusion incidence in cardiac surgery: a single-centre, randomised, open-label, parallel-group controlled pilot trial. Lancet Reg Health Eur. 2024 Jun 24;43:100966. doi: 10.1016/j.lanepe.2024.100966. eCollection 2024 Aug.
Related trials for Cardiac Surgery
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Recruiting
Change in Platelet Lipid Metabolism and Procoagulant Phenotype Induced by Cardiopulmonary Bypass. Impact on Postoperative Inflammatory Response and Bleeding Complications During Cardiac Surgery.
Cardiac Surgery, Cardiopulmonary Bypass
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EPO (600UI/Kg, sub-cutaneous) and Ferric Carboxymaltose (FCM) (20 mg/kg in 250 mL of saline solution 0.9% over 15 min) in people with Cardiac Surgery and Transfusion, run by University Hospital, Montpellier at 1 site in France.
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 5 inclusion and 8 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 15 Jun 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 France. 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?
Transfusion incidence at hospital discharge (time frame: up to Day 28). 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 NCT04141631, 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 15 Jun 2026.