Effect of the Combined Programme on Perioperative Anaemia（CPPA）

January 8, 2025 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Perioperative anaemia is one of the most common comorbidities in patients undergoing surgery, with a prevalence of up to 30% in patients undergoing cardiac surgery. Perioperative anaemia can lead to ischaemia and hypoxia in vital organs, increased postoperative complications and even increased mortality; in addition to an increased rate of allogeneic blood product transfusions and significantly longer ICU and hospital stays. Correcting perioperative anaemia and reducing complications are of great importance to improve the immediate and long-term prognosis of patients undergoing major cardiac surgery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • The Second Affiliated Hospital of Zhejiang University Medical College
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  1. Allergy or contraindication to iron sucrose or recombinant human erythropoietin or ascorbic acid
  2. Patients with a preoperative temperature >37.5 °C or on non-prophylactic antibiotics
  3. Pregnancy or breastfeeding stage
  4. weight ≤ 50 kg
  5. Presence of chronic renal insufficiency, urinary stones, oxalate deposits, gout
  6. Chronic liver disease and/or screening alanine transferase/aspartate transferase above normal 3 times or more above the upper limit of the normal range
  7. Family history of haemochromatosis, thalassaemia or transferrin saturation > 50%
  8. Known history of iron overload
  9. Other known causes of anaemia (folic acid or vitamin B12 deficiency or haemoglobinopathies, etc.)
  10. Emergency surgery
  11. Use of iron, blood transfusion or related anaemia treatment within 12 weeks prior to surgery

Withdrawal criteria:

  1. massive blood transfusion (≥ 10 red blood cells (RBC)/24h)
  2. Preoperative interventions not performed according to standard
  3. Cancellation of surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Iron treatment intervention arm
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
Drug: Iron Sucrose, recombinant human erythropoietin, ascorbic acid
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.
Active Comparator: conventional treatment arm
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
Procedure: conventional treatment
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Haemoglobin level on postoperative day 5
Time Frame: Haemoglobin level on postoperative day 5
Haemoglobin level on postoperative day 5
Haemoglobin level on postoperative day 5

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
(red blood cells, plasma, platelets)
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
Pre-intervention versus post-operative haemoglobin
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
Pre-intervention versus post-operative ferritin
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
Magnitude of reticulocyte elevation
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
Postoperative creatinine more than 2 times higher than preoperative or oliguria (<0.5ml/kg/h) within 12 hours
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
Perioperative allergic events
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
Myocardial infarction、Ischemic cerebral infarction、arrhythmia、Deep vein thrombosis of the lower extremity、Pulmonary embolism, etc
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
Incidence of mortality
Through study completion, an average of 1.5 year
Total length of hospital stay
Time Frame: Through study completion, an average of 1 year
Total length of hospital stay
Through study completion, an average of 1 year
Incidence of perioperative infections
Time Frame: Through study completion, an average of 1 year
Non-prophylactic use of antibiotics
Through study completion, an average of 1 year
Post-operative intensive care unit stay
Time Frame: From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
Length of stay in ICU after surgery
From the start of surgery until hospital discharge or postoperative day 30, whichever comes first
Health Care Costs
Time Frame: From admission until hospital discharge or postoperative day 30, whichever comes first
All medical costs during hospitalisation
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
Post-operative hospital readmission rate
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Min Yan, Doctor, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-0156

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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