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Recruiting NCT06968936

Long-term Outcomes Sub-Study of Preoperative Combined Iron Therapy

No phase Interventional Anemia Iron Deficiencies Cardiac Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sucrose Iron，subcutaneous recombinant human erythropoietin，intravenous vitamin C, Routine perioperative management.
Who it may be relevant to
Registry conditions: Anemia, Iron Deficiencies, Cardiac Surgery. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Long-term Outcomes Sub-Study of Preoperative Combined Iron Therapy in Anemic Patients Undergoing Cardiac Surgery: A Randomized Controlled Trial

Overview

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.

Interventions

  • Drug Sucrose Iron，subcutaneous recombinant human erythropoietin，intravenous vitamin C
    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.
  • Procedure Routine perioperative management
    Routine perioperative management based on clinical judgment, including observation, monitoring, and standard nursing practices.

Primary outcome measures

  • Quality of Life (EQ-5D) [Time frame: 1 year postoperatively (±30 days)]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Department of Anesthesiology, Second Affiliated Hospital, Zhejiang University School of Me — Hangzhou

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. PMID 33475735
  • Fowler 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/ PMID 30442249
  • Carson 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. PMID 36315909
  • Spahn 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. PMID 31036337
  • Attallah 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. PMID 16564942

Identifiers

NCT: NCT06968936 · 20240384

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗