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New treatment option for Patient Blood Management
Official title Effect of the Combined Programme on Perioperative Anaemia（CPPA）
ClinicalTrials.gov ID: NCT05353348
What this study is testing
What is Iron Sucrose, recombinant human erythropoietin, ascorbic acid?
Iron Sucrose, recombinant human erythropoietin, ascorbic acid is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for patient blood management.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
See the full eligibility 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
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.