AnemiaCIPATNCT06012760
The Effect of Combined Iron Protocols on Perioperative Allogeneic Transfusion
A study testing Iron sucrose, Human Erythropoietin Injection, Vitamin C and Standard Medical Care in people with Anemia and Iron Deficiency Anemia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if a combined iron supplementation regimen can reduce the need for blood transfusions in adults with iron-deficiency anemia undergoing major elective cardiac surgery. The trial will also look at whether this regimen is safe and well tolerated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Iron Deficiency Anemia, Perioperative
- What is being tested?
- Iron sucrose, Human Erythropoietin Injection, Vitamin C and Standard Medical Care
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2025to 31 Mar 2028
- 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
- Participants must be at least 18 years of age.
- Major cardiac surgery should encompass procedures such as coronary artery bypass grafting (CABG), valve surgery, or a combination of both.
- Iron deficiency anemia is defined as having a ferritin level below 100 μg/L or a ferritin level below 300 μg/L accompanied by a transferrin saturation below 25%. Additionally, hemoglobin levels should range between 90 and 130 g/L for men or between 90 and 120 g/L for women.
- The American Society of Anesthesiologists (ASA) classification should fall within Grade 1-3.
- Prior to participation, the patient or their legal representative must provide informed consent.
Who cannot join
- Contraindications for the administration of iron sucrose, ascorbic acid, or rHuEPO.
- Presence of a temperature exceeding 37.5 °C or the utilization of non-prophylactic antibiotics.
- Individuals with a weight equal to or less than 50kg.
- Individuals with a family history of haemochromatosis or thalassaemia, or those with a transferrin saturation level exceeding 50% or a documented history of iron overload.
- Presence of other known haematological disorders such as folic acid or vitamin B12 deficiency, haemolytic anaemia, haemoglobinopathies, iron granulocytic anaemia, G6PD deficiency, etc.
- Requirement for emergency surgical intervention.
Show all 10Show fewer
- Severe hepatic or renal impairment, ALT >3 times the upper limit of normal value or AST >3 times the upper limit of normal value, creatinine >1.5 times the upper limit of normal value
- Pregnant or lactating women
- history of blood transfusion, intravenous iron or ascorbic acid use within 12 weeks prior to surgery
- Acute blood loss, gastrointestinal bleeding, etc. in the preoperative period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Zhejiang University anesthesiology department
Hangzhou, Zhejiang, 310000
Min Yan, Doctor, 15888210247, zryanmin@zju.edu.cn
Min Yan, Doctor
About this study
Official title: Effect of Iron Sucrose Combined With Human Erythropoietin and Vitamin C on Perioperative Allogeneic Red Blood Cell Infusion in Major Cardiac Surgery
The goal of this clinical trial is to learn if a combined iron supplementation regimen can reduce the need for blood transfusions in adults with iron-deficiency anemia undergoing major elective cardiac surgery. The trial will also look at whether this regimen is safe and well tolerated. The main questions it aims to answer are:
Does the combined regimen lower the amount of allogeneic red blood cell transfusion needed during and after surgery?
Read more
Are there any side effects or safety concerns associated with the regimen?
Researchers will compare the combined iron supplementation (sucrose iron, erythropoietin, and vitamin C) to standard care to see if it helps reduce blood transfusions.
Participants will:
Receive either the combined regimen or standard care before surgery
Undergo major elective cardiac surgery under general anesthesia
Be monitored for blood transfusion needs and recovery up to 90 days after surgery
Read the detailed description
- Hypothesis:The combined protocol of preoperative sucrose iron, human erythropoietin, and vitamin C will demonstrate superiority in reducing perioperative allogeneic red blood cell (RBC) transfusion volume compared to standard care in patients with iron deficiency anemia undergoing major cardiac surgery with cardiopulmonary bypass.
- Interventions 2.1.Experimental group: Patients in the experimental group will receive a combination therapy consisting of intravenous sucrose iron (200 mg), subcutaneous recombinant human erythropoietin (150 IU/kg), and intravenous vitamin C (2 g), administered once daily for three consecutive days within the week prior to surgery. 2.2.Control group: Routine perioperative management based on clinical judgment, including observation, monitoring, and standard nursing practices.
- Primary endpoint: Total volume of allogeneic RBC transfusion (units) from surgery initiation to postoperative day 5.
- Stratification in randomization: Stratification factors include types of surgery, preoperative baseline hemoglobin level.
- Follow-up time important points include: baseline upon hospital admission, the morning of surgery, postoperative day 1, postoperative day 5, at discharge, 30 ± 7 days after surgery, and 90 ± 7 days after surgery.
- All perioperative transfusion decisions will follow standardized restrictive transfusion thresholds. When the patient's hemoglobin concentration falls below the threshold of 70 g/L during surgery or ICU monitoring, or below 70-80 g/L in the general ward, and/or when signs of anemia or hemodynamic instability are present-including shock, severe arrhythmias, respiratory distress, heart rate >120 beats/min, systolic blood pressure (SBP) <80 mmHg, mean arterial pressure (MAP) <55-60 mmHg, or a reduction in SBP or MAP exceeding 25% from baseline-these findings may indicate significant hypovolemia and warrant consideration of transfusion intervention.
- Conditions
- Anemia, Iron Deficiency Anemia, Perioperative, Transfusion, Cardiac Surgery
- Being tested
- Iron sucrose, Human Erythropoietin Injection, Vitamin C, Standard Medical Care
- Medical subject headings
- Anemia, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron sucrose, Human Erythropoietin Injection, Vitamin CDrug
The participants were administered a combined iron supplementation regimen consisting of iron sucrose,Human Erythropoietin Injection, and vitamin C, three times throughout the preoperative week.
Standard Medical CareDrug
Standard Medical Care (SMC) for the treatment of IDA. SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).
| Study group | Role | What they receive |
|---|---|---|
| Combined Iron Protocols group（CIP group） | Experimental | Preoperative randomization was conducted, followed by a three-day regimen in the week preceding surgery, involving the administration of intravenous iron sucrose at a dosage of 200 mg per day, vitamin C at a dosage of 2 g per day, and subcutaneous administration of Human Erythropoietin Injection at a dosage of 150 IU per kilogram. Receives: Drug: Iron sucrose, Human Erythropoietin Injection, Vitamin C |
| Standard Medical Care group（SMC group） | Active comparator | Standard Medical Care (SMC) for the treatment of IDA. SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA). Receives: Drug: Standard Medical Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative allogeneic red blood cell transfusion volume
The volume of allogeneic red blood cell transfusions during the perioperative period.
Measured: From the initiation of the surgical procedure until five days post-surgery.
Secondary outcomes (9)
The quantity and percentage of allogeneic blood products utilized during the perioperative period.
This encompasses blood components such as plasma and platelets, erythrocytes.
Measured: From the initiation of the surgical procedure until until 90± 7 days following the surgical procedure.
The alterations in perioperative haemoglobin levels.
Haemoglobin levels were assessed at various time intervals.
Measured: From the point of randomisation until 90± 7 days following the surgical procedure.
The alterations in ferritin levels and TSAT during the perioperative period.
Ferritin and Transferrin Saturation values were assessed at various time intervals.
Measured: From the point of randomisation until 90± 7 days following the surgical procedure.
The alterations in reticulocyte levels during the perioperative period.
Reticulocyte levels were measured at various time intervals.
Measured: From the point of randomisation until 90± 7 days following the surgical procedure.
The score measuring the quality of life after surgery.
The findings are presented based on the EQ VAS score (0-100), which reflects the overall self-assessed health status. A higher score indicates a better health status. Additionally, the results are reported using the EQ-5D-3L Effectiveness Index (EQ-5D-3L) values (5-15), where a lower EQ-5D-3L value signifies a better state of health.
Measured: From the point of randomisation until 90± 7 days following the surgical procedure.
Incidence of perioperative complication within 90 days after major cardiac surgery
The potential postoperative complications within acute kidney injury (AKI), serious adverse events (SAE), congestive heart failure, respiratory failure, Allergic reaction, Thrombotic and thromboembolic complications and various infections.
Measured: From the point of randomisation until 90± 7 days following the surgical procedure.
The mortality rate within 30-day and 90-day postoperative period.
The mortality rate within 30-day and 90-day postoperative period.
Measured: Within 90± 7 days after surgery
length of stay in hospital
The time period from admission to the hospital to discharge
Measured: Within 90± 7 days after surgery
Length of stay in ICU
The time period from admission to ICU after surgery to move out from ICU to normal ward
Measured: Within 90± 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start4 Jan 2025
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Mar 2028 (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 AnemiaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Wenzhou Medical University, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, The Central Hospital of Lishui City, First Affiliated Hospital of Chongqing Medical University, Zhejiang Provincial People's Hospital, The Fourth Affiliated Hospital of Zhejiang University School of Medicine, First Affiliated Hospital of Zhejiang University, Affiliated Hospital of Nanjing University of Chinese Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012760
- Sponsor's protocol ID
- A2023519
- Acronym
- CIPAT
- Status last verified
- May 2026
- First submitted
- 22 Aug 2023
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Other researchers could email us to ask the data information.
Publications
Zeroual N, Blin C, Saour M, David H, Aouinti S, Picot MC, Colson PH, Gaudard P. Restrictive Transfusion Strategy after Cardiac Surgery. Anesthesiology. 2021 Mar 1;134(3):370-380. doi: 10.1097/ALN.0000000000003682.
PubMed 33475735Fowler AJ, Ahmad T, Abbott TEF, Torrance HD, Wouters PF, De Hert S, Lobo SM, Rasmussen LS, Della Rocca G, Beattie WS, Wijeysundera DN, Pearse RM; International Surgical Outcomes Study Group. Association of preoperative anaemia with postoperative morbidity and mortality: an observational cohort study in low-, middle-, and high-income countries. Br J Anaesth. 2018 Dec;121(6):1227-1235. doi: 10.1016/j.bja.2018.08.026. Epub 2018 Oct 25.
PubMed 30442249Carson JL, Brittenham GM. How I treat anemia with red blood cell transfusion and iron. Blood. 2023 Aug 31;142(9):777-785. doi: 10.1182/blood.2022018521.
PubMed 36315909Spahn DR, Schoenrath F, Spahn GH, Seifert B, Stein P, Theusinger OM, Kaserer A, Hegemann I, Hofmann A, Maisano F, Falk V. Effect of ultra-short-term treatment of patients with iron deficiency or anaemia undergoing cardiac surgery: a prospective randomised trial. Lancet. 2019 Jun 1;393(10187):2201-2212. doi: 10.1016/S0140-6736(18)32555-8. Epub 2019 Apr 26.
PubMed 31036337Attallah N, Osman-Malik Y, Frinak S, Besarab A. Effect of intravenous ascorbic acid in hemodialysis patients with EPO-hyporesponsive anemia and hyperferritinemia. Am J Kidney Dis. 2006 Apr;47(4):644-54. doi: 10.1053/j.ajkd.2005.12.025.
PubMed 16564942
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Iron Sucrose Combined With Human Erythropoietin and Vitamin C on Perioperative Allogeneic Red Blood Cell Infusion in Major Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06012760
- Acronym / sponsor ID
- CIPAT / A2023519
- Conditions
- Anemia, Iron Deficiency Anemia, Perioperative, Transfusion, Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Wenzhou Medical University, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, The Central Hospital of Lishui City, First Affiliated Hospital of Chongqing Medical University, Zhejiang Provincial People's Hospital, The Fourth Affiliated Hospital of Zhejiang University School of Medicine, First Affiliated Hospital of Zhejiang University, Affiliated Hospital of Nanjing University of Chinese Medicine
- Study start
- 4 Jan 2025 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 25 Aug 2023 (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 goal of this clinical trial is to learn if a combined iron supplementation regimen can reduce the need for blood transfusions in adults with iron-deficiency anemia undergoing major elective cardiac surgery. The trial will also look at whether this regimen is safe and well tolerated. The main questions it aims to answer are:
Does the combined regimen lower the amount of allogeneic red blood cell transfusion needed during and after surgery?
Are there any side effects or safety concerns associated with the regimen?
Researchers will compare the combined iron supplementation (sucrose iron, erythropoietin, and vitamin C) to standard care to see if it helps reduce blood transfusions.
Participants will:
Receive either the combined regimen or standard care before surgery
Undergo major elective cardiac surgery under general anesthesia
Be monitored for blood transfusion needs and recovery up to 90 days after surgery
Detailed description
- Hypothesis:The combined protocol of preoperative sucrose iron, human erythropoietin, and vitamin C will demonstrate superiority in reducing perioperative allogeneic red blood cell (RBC) transfusion volume compared to standard care in patients with iron deficiency anemia undergoing major cardiac surgery with cardiopulmonary bypass.
- Interventions 2.1.Experimental group: Patients in the experimental group will receive a combination therapy consisting of intravenous sucrose iron (200 mg), subcutaneous recombinant human erythropoietin (150 IU/kg), and intravenous vitamin C (2 g), administered once daily for three consecutive days within the week prior to surgery. 2.2.Control group: Routine perioperative management based on clinical judgment, including observation, monitoring, and standard nursing practices.
- Primary endpoint: Total volume of allogeneic RBC transfusion (units) from surgery initiation to postoperative day 5.
- Stratification in randomization: Stratification factors include types of surgery, preoperative baseline hemoglobin level.
- Follow-up time important points include: baseline upon hospital admission, the morning of surgery, postoperative day 1, postoperative day 5, at discharge, 30 ± 7 days after surgery, and 90 ± 7 days after surgery.
- All perioperative transfusion decisions will follow standardized restrictive transfusion thresholds. When the patient's hemoglobin concentration falls below the threshold of 70 g/L during surgery or ICU monitoring, or below 70-80 g/L in the general ward, and/or when signs of anemia or hemodynamic instability are present-including shock, severe arrhythmias, respiratory distress, heart rate >120 beats/min, systolic blood pressure (SBP) <80 mmHg, mean arterial pressure (MAP) <55-60 mmHg, or a reduction in SBP or MAP exceeding 25% from baseline-these findings may indicate significant hypovolemia and warrant consideration of transfusion intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined Iron Protocols group（CIP group） | Experimental | Drug: Iron sucrose, Human Erythropoietin Injection, Vitamin CPreoperative randomization was conducted, followed by a three-day regimen in the week preceding surgery, involving the administration of intravenous iron sucrose at a dosage of 200 mg per day, vitamin C at a dosage of 2 g per day, and subcutaneous administration of Human Erythropoietin Injection at a dosage of 150 IU per kilogram. |
| Standard Medical Care group（SMC group） | Active comparator | Drug: Standard Medical CareStandard Medical Care (SMC) for the treatment of IDA. SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants must be at least 18 years of age.
- Major cardiac surgery should encompass procedures such as coronary artery bypass grafting (CABG), valve surgery, or a combination of both.
- Iron deficiency anemia is defined as having a ferritin level below 100 μg/L or a ferritin level below 300 μg/L accompanied by a transferrin saturation below 25%. Additionally, hemoglobin levels should range between 90 and 130 g/L for men or between 90 and 120 g/L for women.
- The American Society of Anesthesiologists (ASA) classification should fall within Grade 1-3.
- Prior to participation, the patient or their legal representative must provide informed consent.
Key exclusion criteria (10 listed)
- Contraindications for the administration of iron sucrose, ascorbic acid, or rHuEPO.
- Presence of a temperature exceeding 37.5 °C or the utilization of non-prophylactic antibiotics.
- Individuals with a weight equal to or less than 50kg.
- Individuals with a family history of haemochromatosis or thalassaemia, or those with a transferrin saturation level exceeding 50% or a documented history of iron overload.
- Presence of other known haematological disorders such as folic acid or vitamin B12 deficiency, haemolytic anaemia, haemoglobinopathies, iron granulocytic anaemia, G6PD deficiency, etc.
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 |
|---|---|---|
| Iron sucrose, Human Erythropoietin Injection, Vitamin CThe participants were administered a combined iron supplementation regimen consisting of iron sucrose,Human Erythropoietin Injection, and vitamin C, three times throughout the preoperative week. | Drug | Combined Iron Protocols group（CIP group） |
| Standard Medical CareStandard Medical Care (SMC) for the treatment of IDA. SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA). | Drug | Standard Medical Care group（SMC group） |
Primary outcome
Perioperative allogeneic red blood cell transfusion volume
Time frame: From the initiation of the surgical procedure until five days post-surgery.
The volume of allogeneic red blood cell transfusions during the perioperative period.
9 secondary outcomes
The quantity and percentage of allogeneic blood products utilized during the perioperative period.
Time frame: From the initiation of the surgical procedure until until 90± 7 days following the surgical procedure.
The alterations in perioperative haemoglobin levels.
Time frame: From the point of randomisation until 90± 7 days following the surgical procedure.
The alterations in ferritin levels and TSAT during the perioperative period.
Time frame: From the point of randomisation until 90± 7 days following the surgical procedure.
The alterations in reticulocyte levels during the perioperative period.
Time frame: From the point of randomisation until 90± 7 days following the surgical procedure.
The score measuring the quality of life after surgery.
Time frame: From the point of randomisation until 90± 7 days following the surgical procedure.
Incidence of perioperative complication within 90 days after major cardiac surgery
Time frame: From the point of randomisation until 90± 7 days following the surgical procedure.
The mortality rate within 30-day and 90-day postoperative period.
Time frame: Within 90± 7 days after surgery
length of stay in hospital
Time frame: Within 90± 7 days after surgery
Length of stay in ICU
Time frame: Within 90± 7 days after surgery
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 2 Jun 2026.
- Background: PubMed 33475735Zeroual N, Blin C, Saour M, David H, Aouinti S, Picot MC, Colson PH, Gaudard P. Restrictive Transfusion Strategy after Cardiac Surgery. Anesthesiology. 2021 Mar 1;134(3):370-380. doi: 10.1097/ALN.0000000000003682.
- Background: PubMed 30442249Fowler AJ, Ahmad T, Abbott TEF, Torrance HD, Wouters PF, De Hert S, Lobo SM, Rasmussen LS, Della Rocca G, Beattie WS, Wijeysundera DN, Pearse RM; International Surgical Outcomes Study Group. Association of preoperative anaemia with postoperative morbidity and mortality: an observational cohort study in low-, middle-, and high-income countries. Br J Anaesth. 2018 Dec;121(6):1227-1235. doi: 10.1016/j.bja.2018.08.026. Epub 2018 Oct 25.
- Background: PubMed 36315909Carson JL, Brittenham GM. How I treat anemia with red blood cell transfusion and iron. Blood. 2023 Aug 31;142(9):777-785. doi: 10.1182/blood.2022018521.
- Background: PubMed 31036337Spahn DR, Schoenrath F, Spahn GH, Seifert B, Stein P, Theusinger OM, Kaserer A, Hegemann I, Hofmann A, Maisano F, Falk V. Effect of ultra-short-term treatment of patients with iron deficiency or anaemia undergoing cardiac surgery: a prospective randomised trial. Lancet. 2019 Jun 1;393(10187):2201-2212. doi: 10.1016/S0140-6736(18)32555-8. Epub 2019 Apr 26.
- Background: PubMed 16564942Attallah N, Osman-Malik Y, Frinak S, Besarab A. Effect of intravenous ascorbic acid in hemodialysis patients with EPO-hyporesponsive anemia and hyperferritinemia. Am J Kidney Dis. 2006 Apr;47(4):644-54. doi: 10.1053/j.ajkd.2005.12.025.
- Individual participant dataSharing planned: Undecided. Other researchers could email us to ask the data information.
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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.
The Second Affiliated Hospital of Zhejiang University anesthesiology department
Hangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron sucrose, Human Erythropoietin Injection, Vitamin C and Standard Medical Care in people with Anemia and Iron Deficiency Anemia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 10 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 2 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 China. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative allogeneic red blood cell transfusion volume (time frame: From the initiation of the surgical procedure until five days post-surgery.). 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 NCT06012760, 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 2 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.