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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.
• Процедура Routine perioperative management
  Routine perioperative management based on clinical judgment, including observation, monitoring, and standard nursing practices.

Первичные конечные точки

• Quality of Life (EQ-5D) [Срок оценки: 1 year postoperatively (±30 days)]

Вторичные конечные точки (6)

• Sleep Quality (Pittsburgh Sleep Quality Index, PSQI) [Срок оценки: 1 year postoperatively (±30 days)]
• Fatigue (FACIT-Fatigue Scale) [Срок оценки: 1 year postoperatively (±30 days)]
• All-cause Complications [Срок оценки: Up to 1 year postoperatively]
• Hospital Readmission [Срок оценки: Up to 1 year postoperatively]
• Repeat Cardiac Surgery [Срок оценки: Up to 1 year postoperatively]
• All-cause Mortality [Срок оценки: Up to 1 year postoperatively]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Department of Anesthesiology, Second Affiliated Hospital, Zhejiang University School of Me — Ханчжоу

Публикации

• 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

Идентификаторы

NCT: NCT06968936 · 20240384

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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