Patient Blood ManagementNCT05353348
Effect of the Combined Programme on Perioperative Anaemia（CPPA）
A study testing Iron Sucrose, recombinant human erythropoietin, ascorbic acid and conventional treatment in people with Patient Blood Management and Cardiac Surgery, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
We used the preoperative intervention of iron sucrose in combination with human erythropoietin and vitamin C as an innovative combination therapy. This combined treatment strategy aims to improve perioperative anaemia in patients by promoting erythropoiesis and improving iron metabolism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Blood Management, Cardiac Surgery, Iron Deficiency Anemia
- What is being tested?
- Iron Sucrose, recombinant human erythropoietin, ascorbic acid and conventional treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2023to 1 Apr 2025
- 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
- Age 18 years and above
- Ferritin <300µg/L, transferrin saturation <25%, male 90<Hb<130g/L or female 90<Hb<120g/L
- Elective major cardiac surgery (valve replacement, CABG coronary artery bypass surgery or a combination of both)
- ASA: Grade 1-3
- Signed informed consent
Who cannot join
- Allergy or contraindication to iron sucrose or recombinant human erythropoietin or ascorbic acid
- Patients with a preoperative temperature >37.5 °C or on non-prophylactic antibiotics
- Pregnancy or breastfeeding stage
- weight ≤ 50 kg
- Presence of chronic renal insufficiency, urinary stones, oxalate deposits, gout
- Chronic liver disease and/or screening alanine transferase/aspartate transferase above normal 3 times or more above the upper limit of the normal range
Show all 15Show fewer
- Family history of haemochromatosis, thalassaemia or transferrin saturation > 50%
- Known history of iron overload
- Other known causes of anaemia (folic acid or vitamin B12 deficiency or haemoglobinopathies, etc.)
- Emergency surgery
- Use of iron, blood transfusion or related anaemia treatment within 12 weeks prior to surgery
- Withdrawal criteria:
- massive blood transfusion (≥ 10 red blood cells (RBC)/24h)
- Preoperative interventions not performed according to standard
- Cancellation of surgery
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 Medical College
Hangzhou, Zhejiang, 310000
Min Yan, Doctor, 15888210247, zryanmin@zju.edu.cn
About this study
Official title: Effectiveness of Iron Sucrose Combined With rHuEPO and Ascorbic Acid in Improving Perioperative Anaemia in Patients Undergoing Major Cardiac Surgery
We used the preoperative intervention of iron sucrose in combination with human erythropoietin and vitamin C as an innovative combination therapy. This combined treatment strategy aims to improve perioperative anaemia in patients by promoting erythropoiesis and improving iron metabolism. Compared with previous perioperative intravenous iron supplementation, this innovative combination therapy strategy takes into account multiple aspects of iron metabolism as well as the biological mechanisms of erythropoiesis, providing a more comprehensive intervention. Management of perioperative anaemia in previous studies has largely relied on single intravenous iron supplementation therapy, and although this approach has been effective in raising iron levels, its effectiveness may be limited in patients who have impaired iron utilisation or in situations where concurrent stimulation of erythropoiesis is required. The use of iron sucrose in combination with human erythropoietin and vitamin C, on the other hand, is based on an integrative therapeutic concept aimed at providing a more comprehensive response to perioperative anaemia by simultaneously promoting effective iron utilisation and erythropoiesis.
- Being tested
- Iron Sucrose, recombinant human erythropoietin, ascorbic acid, conventional treatment
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron Sucrose, recombinant human erythropoietin, ascorbic acidDrug
During the 1 week period following admission, 3 consecutive dosing regimens were administered, 200 mg of iron sucrose by intravenous infusion at 8am daily in combination with 150 IU/kg of recombinant human erythropoietin by subcutaneous injection and 2 g of ascorbic acid by intravenous infusion.
conventional treatmentProcedure or surgery
Treatment in accordance with measures routinely used by the surgeon's team to treat anemia including but not limited to (clinical observation, oral iron supplementation, intravenous iron supplementation, blood transfusion, or other measures) will be documented faithfully by the study team
| Study group | Role | What they receive |
|---|---|---|
| Iron treatment intervention arm | Experimental | The combination therapy group will receive three treatments consisting of 200 mg/100 ml of iron sucrose IV infusion, 150 IU/Kg of erythropoietin subcutaneously and 2 mg/100 ml of vitamin C IV infusion in the week prior to surgery Receives: Drug: Iron Sucrose, recombinant human erythropoietin, ascorbic acid |
| conventional treatment arm | Active comparator | Treatment in accordance with measures routinely used by the surgeon's team to treat anemia including but not limited to (clinical observation, oral iron supplementation, intravenous iron supplementation, blood transfusion, or other measures) will be documented faithfully by the study team Receives: Procedure: conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemoglobin level on postoperative day 5
Haemoglobin level on postoperative day 5
Measured: Haemoglobin level on postoperative day 5
Secondary outcomes (13)
Amount of allogeneic blood products used in the perioperative period
(red blood cells, plasma, platelets)
Measured: From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
Effect of combination therapy on changes in perioperative haemoglobin levels
Pre-intervention versus post-operative haemoglobin
Measured: From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
Effect of combination therapy on changes in perioperative ferritin levels
Pre-intervention versus post-operative ferritin
Measured: From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
Effect of combination therapy on changes in perioperative reticulocyte levels
Magnitude of reticulocyte elevation
Measured: From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
Incidence of perioperative acute renal insufficiency
Postoperative creatinine more than 2 times higher than preoperative or oliguria (<0.5ml/kg/h) within 12 hours
Measured: From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
Post-operative intensive care unit stay
Length of stay in ICU after surgery
Measured: From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
Infusion reactions and allergies
Perioperative allergic events
Measured: From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
Incidence of serious adverse events (SAEs) in the perioperative period up to 6 months after surgery
Myocardial infarction、Ischemic cerebral infarction、arrhythmia、Deep vein thrombosis of the lower extremity、Pulmonary embolism, etc
Measured: Through study completion, an average of 1.5 year
All-cause mortality within 6 months of surgery
Incidence of mortality
Measured: Through study completion, an average of 1.5 year
Total length of hospital stay
Total length of hospital stay
Measured: Through study completion, an average of 1 year
Incidence of perioperative infections
Non-prophylactic use of antibiotics
Measured: Through study completion, an average of 1 year
Health Care Costs
All medical costs during hospitalisation
Measured: From admission until hospital discharge or postoperative day 30, whichever comes first
Post-operative hospital readmission rate
Post-operative hospital readmission rate
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start15 Mar 2023
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Blood ManagementStudies 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
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min Yan, Doctor, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353348
- Sponsor's protocol ID
- 2022-0156
- Status last verified
- Dec 2024
- First submitted
- 19 Apr 2022
- Last updated
- 10 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Iron Sucrose Combined With rHuEPO and Ascorbic Acid in Improving Perioperative Anaemia in Patients Undergoing Major Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05353348
- Acronym / sponsor ID
- 2022-0156
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 29 Apr 2022 (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.
We used the preoperative intervention of iron sucrose in combination with human erythropoietin and vitamin C as an innovative combination therapy. This combined treatment strategy aims to improve perioperative anaemia in patients by promoting erythropoiesis and improving iron metabolism. Compared with previous perioperative intravenous iron supplementation, this innovative combination therapy strategy takes into account multiple aspects of iron metabolism as well as the biological mechanisms of erythropoiesis, providing a more comprehensive intervention. Management of perioperative anaemia in previous studies has largely relied on single intravenous iron supplementation therapy, and although this approach has been effective in raising iron levels, its effectiveness may be limited in patients who have impaired iron utilisation or in situations where concurrent stimulation of erythropoiesis is required. The use of iron sucrose in combination with human erythropoietin and vitamin C, on the other hand, is based on an integrative therapeutic concept aimed at providing a more comprehensive response to perioperative anaemia by simultaneously promoting effective iron utilisation and erythropoiesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iron treatment intervention arm | Experimental | Drug: Iron Sucrose, recombinant human erythropoietin, ascorbic acidThe combination therapy group will receive three treatments consisting of 200 mg/100 ml of iron sucrose IV infusion, 150 IU/Kg of erythropoietin subcutaneously and 2 mg/100 ml of vitamin C IV infusion in the week prior to surgery |
| conventional treatment arm | Active comparator | Procedure: conventional treatmentTreatment in accordance with measures routinely used by the surgeon's team to treat anemia including but not limited to (clinical observation, oral iron supplementation, intravenous iron supplementation, blood transfusion, or other measures) will be documented faithfully by the study team |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years and above
- Ferritin <300µg/L, transferrin saturation <25%, male 90<Hb<130g/L or female 90<Hb<120g/L
- Elective major cardiac surgery (valve replacement, CABG coronary artery bypass surgery or a combination of both)
- ASA: Grade 1-3
- Signed informed consent
Key exclusion criteria (15 listed)
- Allergy or contraindication to iron sucrose or recombinant human erythropoietin or ascorbic acid
- Patients with a preoperative temperature >37.5 °C or on non-prophylactic antibiotics
- Pregnancy or breastfeeding stage
- weight ≤ 50 kg
- Presence of chronic renal insufficiency, urinary stones, oxalate deposits, gout
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, recombinant human erythropoietin, ascorbic acidDuring the 1 week period following admission, 3 consecutive dosing regimens were administered, 200 mg of iron sucrose by intravenous infusion at 8am daily in combination with 150 IU/kg of recombinant human erythropoietin by subcutaneous injection and 2 g of ascorbic acid by intravenous infusion. | Drug | Iron treatment intervention arm |
| conventional treatmentTreatment in accordance with measures routinely used by the surgeon's team to treat anemia including but not limited to (clinical observation, oral iron supplementation, intravenous iron supplementation, blood transfusion, or other measures) will be documented faithfully by the study team | Procedure or surgery | conventional treatment arm |
Primary outcome
Haemoglobin level on postoperative day 5
Time frame: Haemoglobin level on postoperative day 5
Haemoglobin level on postoperative day 5
13 secondary outcomes
Amount of allogeneic blood products used in the perioperative period
Time frame: From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
Effect of combination therapy on changes in perioperative haemoglobin levels
Time frame: From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
Effect of combination therapy on changes in perioperative ferritin levels
Time frame: From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
Effect of combination therapy on changes in perioperative reticulocyte levels
Time frame: From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
Incidence of perioperative acute renal insufficiency
Time frame: From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
Post-operative intensive care unit stay
Time frame: From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
Infusion reactions and allergies
Time frame: From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
Incidence of serious adverse events (SAEs) in the perioperative period up to 6 months after surgery
Time frame: Through study completion, an average of 1.5 year
All-cause mortality within 6 months of surgery
Time frame: Through study completion, an average of 1.5 year
Total length of hospital stay
Time frame: Through study completion, an average of 1 year
Incidence of perioperative infections
Time frame: Through study completion, an average of 1 year
Health Care Costs
Time frame: From admission until hospital discharge or postoperative day 30, whichever comes first
Post-operative hospital readmission rate
Time frame: Through study completion, an average of 1 year
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 10 Jan 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Patient Blood Management
Recruiting
IMB-Guided Health Education Intervention for Medication Adherence and Blood Pressure Control in Non-adherent Hypertensive Patients
Hypertension
Active, not recruiting
Empowering Faith-based Communities to Provide Personalized Diabetes Self-management Education and Support (DSMES) in the Magic City
Blood Cholesterol, Blood Pressure Monitoring
Active, not recruiting
Patient-driven Management of BP in CKD
Chronic Kidney Disease
Active, not recruitingObservational study
Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant
Hematopoietic/Lymphoid Cancer, Accelerated Phase Chronic Myelogenous Leukemia
Not yet recruitingObservational study
Patient Blood Management in Obstetrics
Patient Blood Management, Blood Product Transfusion for All Conditions
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.
Min Yan, Doctor principal investigator
2nd Affiliated Hospital, School of Medicine, Zhejiang University, 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, recombinant human erythropoietin, ascorbic acid and conventional treatment in people with Patient Blood Management and Cardiac Surgery, 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 15 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 10 Jan 2025. 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 Min Yan (13757118632, zryanmin@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Haemoglobin level on postoperative day 5 (time frame: Haemoglobin level on postoperative day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2025.