AnemiaNCT06968936
Long-term Outcomes Sub-Study of Preoperative Combined Iron Therapy
A study testing Sucrose Iron，subcutaneous recombinant human erythropoietin，intravenous vitamin C and Routine perioperative management in people with Anemia and Iron Deficiencies, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This is a sub-study of the Preoperative Combined Iron Therapy trail in which some participants will be additionally randomized to combined iron supplementation or standarded treatment control to evaluate the impact on long-term outcomes. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Anemia, Iron Deficiencies, Cardiac Surgery
- What is being tested?
- Sucrose Iron，subcutaneous recombinant human erythropoietin，intravenous vitamin C and Routine perioperative management
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 27 Mar 2026to 30 Jun 2029
- 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 to 85 years
- 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
Department of Anesthesiology, Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 330100
Min Yan, +861375711863, zryanmin@zju.edu.cn
About this study
Official title: Long-term Outcomes Sub-Study of Preoperative Combined Iron Therapy in Anemic Patients Undergoing Cardiac Surgery: A Randomized Controlled Trial
This is a sub-study of the Preoperative Combined Iron Therapy trail in which some participants will be additionally randomized to combined iron supplementation or standarded treatment control to evaluate the impact on long-term outcomes.
- Conditions
- Anemia, Iron Deficiencies, Cardiac Surgery
- Being tested
- Sucrose Iron，subcutaneous recombinant human erythropoietin，intravenous vitamin C, Routine perioperative management
- Medical subject headings
- Anemia, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sucrose Iron，subcutaneous recombinant human erythropoietin，intravenous vitamin CDrug
Also called Routine perioperative management
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.
Routine perioperative managementProcedure or surgery
Routine perioperative management based on clinical judgment, including observation, monitoring, and standard nursing practices.
| Study group | Role | What they receive |
|---|---|---|
| Combined Iron Supplementation Group | Experimental | 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. All perioperative transfusion decisions will follow standardized restrictive transfusion thresholds Receives: Drug: Sucrose Iron，subcutaneous recombinant human erythropoietin，intravenous vitamin C |
| Conventional treatment group | Active comparator | Routine perioperative management based on clinical judgment, including observation, monitoring, and standard nursing practices Receives: Procedure: Routine perioperative management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life (EQ-5D)
Assessment of health-related quality of life using the EuroQol 5-Dimension (EQ-5D) questionnaire
Measured: 1 year postoperatively (±30 days)
Secondary outcomes (6)
Sleep Quality (Pittsburgh Sleep Quality Index, PSQI)
Evaluation of sleep quality using the Pittsburgh Sleep Quality Index (PSQI)
Measured: 1 year postoperatively (±30 days)
Fatigue (FACIT-Fatigue Scale)
Measurement of fatigue level using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) scale.
Measured: 1 year postoperatively (±30 days)
All-cause Complications
Occurrence of any postoperative complications from any cause during the 1-year follow-up period
Measured: Up to 1 year postoperatively
Hospital Readmission
Any hospital readmission for any cause within 1 year after surgery.
Measured: Up to 1 year postoperatively
Repeat Cardiac Surgery
Any subsequent cardiac surgery (reoperation) within 1 year after the index surgery.
Measured: Up to 1 year postoperatively
All-cause Mortality
Death from any cause within 1 year after surgery.
Measured: Up to 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start27 Mar 2026
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (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.
- 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
- Model description
- Central stratified block group randomization
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Chongqing Medical University, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, The First Affiliated Hospital with Nanjing Medical University, First Affiliated Hospital of Wenzhou Medical University, Zhejiang Provincial People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968936
- Sponsor's protocol ID
- 20240384
- Status last verified
- Apr 2025
- First submitted
- 13 Apr 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes Sub-Study of Preoperative Combined Iron Therapy in Anemic Patients Undergoing Cardiac Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06968936
- Acronym / sponsor ID
- 20240384
- Conditions
- Anemia, Iron Deficiencies, 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 Chongqing Medical University, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, The First Affiliated Hospital with Nanjing Medical University, First Affiliated Hospital of Wenzhou Medical University, Zhejiang Provincial People's Hospital
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 13 May 2025 (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.
This is a sub-study of the Preoperative Combined Iron Therapy trail in which some participants will be additionally randomized to combined iron supplementation or standarded treatment control to evaluate the impact on long-term outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Central stratified block group randomization
| Arm | Type | Receives |
|---|---|---|
| Combined Iron Supplementation Group | Experimental | Drug: Sucrose Iron，subcutaneous recombinant human erythropoietin，intravenous vitamin CPatients 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. All perioperative transfusion decisions will follow standardized restrictive transfusion thresholds |
| Conventional treatment group | Active comparator | Procedure: Routine perioperative managementRoutine perioperative management based on clinical judgment, including observation, monitoring, and standard nursing practices |
Who may qualify
- Ages
- 18 to 85 years
- 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 |
|---|---|---|
| Sucrose Iron，subcutaneous recombinant human erythropoietin，intravenous vitamin CAlso: Routine perioperative managementPatients 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. | Drug | Combined Iron Supplementation Group |
| Routine perioperative managementRoutine perioperative management based on clinical judgment, including observation, monitoring, and standard nursing practices. | Procedure or surgery | Conventional treatment group |
Primary outcome
Quality of Life (EQ-5D)
Time frame: 1 year postoperatively (±30 days)
Assessment of health-related quality of life using the EuroQol 5-Dimension (EQ-5D) questionnaire
6 secondary outcomes
Sleep Quality (Pittsburgh Sleep Quality Index, PSQI)
Time frame: 1 year postoperatively (±30 days)
Fatigue (FACIT-Fatigue Scale)
Time frame: 1 year postoperatively (±30 days)
All-cause Complications
Time frame: Up to 1 year postoperatively
Hospital Readmission
Time frame: Up to 1 year postoperatively
Repeat Cardiac Surgery
Time frame: Up to 1 year postoperatively
All-cause Mortality
Time frame: Up to 1 year postoperatively
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 13 Apr 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
Related trials for Anemia
Active, not recruitingObservational study
A Prospective, Non-interventional, Observational Study of Presentation, Treatment Patterns and Outcomes in Atypical Hemolytic Uremic Syndrome Patients
Atypical Hemolytic Uremic Syndrome(aHUS)
RecruitingObservational study
Blood Sampling for Research Related to Sickle Cell Disease
Sickle Cell Trait, Sickle Cell Disease
Recruiting
A Long-term Follow-up Study in Participants Who Received CS-101
Beta-Thalassemia
Active, not recruitingPhase 3
A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors
Paroxysmal Nocturnal Hemoglobinuria
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sucrose Iron，subcutaneous recombinant human erythropoietin，intravenous vitamin C and Routine perioperative management in people with Anemia and Iron Deficiencies, 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 13 Apr 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?
Contact Qi Gao, Dr. (19857136919, gaoqi19950203@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (EQ-5D) (time frame: 1 year postoperatively (±30 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06968936, 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 13 Apr 2026.