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

NCT06968936 | Recruiting DMC

• 1 other identifier: 20240384
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anemia; Iron Deficiencies; Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Quality of Life (EQ-5D)

  Assessment of health-related quality of life using the EuroQol 5-Dimension (EQ-5D) questionnaire

  1 year postoperatively (±30 days)

Secondary Outcomes (6)

• Sleep Quality (Pittsburgh Sleep Quality Index, PSQI)

  1 year postoperatively (±30 days)

• Fatigue (FACIT-Fatigue Scale)

  1 year postoperatively (±30 days)

• All-cause Complications

  Up to 1 year postoperatively

• Hospital Readmission

  Up to 1 year postoperatively

• Repeat Cardiac Surgery

  Up to 1 year postoperatively

Study Arms (2)

Combined Iron Supplementation Group

EXPERIMENTAL

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. All perioperative transfusion decisions will follow standardized restrictive transfusion thresholds

Drug: Sucrose Iron，subcutaneous recombinant human erythropoietin，intravenous vitamin C

Conventional treatment group

ACTIVE COMPARATOR

Routine perioperative management based on clinical judgment, including observation, monitoring, and standard nursing practices

Procedure: Routine perioperative management

Interventions

Sucrose Iron，subcutaneous recombinant human erythropoietin，intravenous vitamin C DRUG

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.

Also known as: Routine perioperative management

Combined Iron Supplementation Group

Routine perioperative management PROCEDURE

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

Conventional treatment group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• First Affiliated Hospital of Chongqing Medical University: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Zhejiang Provincial People's Hospital: collaborator
• First Affiliated Hospital of Wenzhou Medical University: collaborator
• Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University: collaborator

Study Sites (1)

Department of Anesthesiology, Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 330100, China

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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/j.bja.2018.08.026. Epub 2018 Oct 25.

  PMID: 30442249 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Anemia; Iron Deficiencies

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Qi Gao, Dr.

CONTACT

19857136919; gaoqi19950203@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding was maintained for outcome assessors, extracorporeal circulation staff, and all investigators not directly involved in the treatment process.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Central stratified block group randomization

Study Record Dates

• First Submitted: April 13, 2025
• First Posted: May 13, 2025
• Study Start: March 27, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: April 13, 2026

Record last verified: 2025-04

Locations

CN (1)