Effect of the Combined Programme on Perioperative Anaemia（CPPA）
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Iron Sucrose, recombinant human erythropoietin, ascorbic acid
DrugDuring 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 treatment
Procedure/SurgeryTreatment 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
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Iron treatment intervention armExperimental treatment 1 intervention
Group B: conventional treatment armActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Haemoglobin level on postoperative day 5
Haemoglobin level on postoperative day 5
Time frame
Haemoglobin level on postoperative day 5Secondary outcomes
1
Amount of allogeneic blood products used in the perioperative period
(red blood cells, plasma, platelets)
Time frame
From the start of surgery until hospital discharge or postoperative day 30, whichever comes first2
Effect of combination therapy on changes in perioperative haemoglobin levels
Pre-intervention versus post-operative haemoglobin
Time frame
From the start of surgery until hospital discharge or postoperative day 30, whichever comes first3
Effect of combination therapy on changes in perioperative ferritin levels
Pre-intervention versus post-operative ferritin
Time frame
From the start of surgery until hospital discharge or postoperative day 30, whichever comes first4
Effect of combination therapy on changes in perioperative reticulocyte levels
Magnitude of reticulocyte elevation
Time frame
From the start of surgery until hospital discharge or postoperative day 30, whichever comes firstSponsors and contacts
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Source ClinicalTrials.gov