The Effect of Combined Iron Protocols on Perioperative Allogeneic Transfusion

NCT06012760 | Recruiting DMC

• 1 other identifier: A2023519
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if a combined iron supplementation regimen can reduce the need for blood transfusions in adults with iron-deficiency anemia undergoing major elective cardiac surgery. The trial will also look at whether this regimen is safe and well tolerated. The main questions it aims to answer are: Does the combined regimen lower the amount of allogeneic red blood cell transfusion needed during and after surgery? Are there any side effects or safety concerns associated with the regimen? Researchers will compare the combined iron supplementation (sucrose iron, erythropoietin, and vitamin C) to standard care to see if it helps reduce blood transfusions. Participants will: Receive either the combined regimen or standard care before surgery Undergo major elective cardiac surgery under general anesthesia Be monitored for blood transfusion needs and recovery up to 90 days after surgery

Conditions

Anemia; Iron Deficiency Anemia; Perioperative; Transfusion; Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Perioperative allogeneic red blood cell transfusion volume

  The volume of allogeneic red blood cell transfusions during the perioperative period.

  From the initiation of the surgical procedure until five days post-surgery.

Secondary Outcomes (9)

• The quantity and percentage of allogeneic blood products utilized during the perioperative period.

  From the initiation of the surgical procedure until until 90± 7 days following the surgical procedure.

• The alterations in perioperative haemoglobin levels.

  From the point of randomisation until 90± 7 days following the surgical procedure.

• The alterations in ferritin levels and TSAT during the perioperative period.

  From the point of randomisation until 90± 7 days following the surgical procedure.

• The alterations in reticulocyte levels during the perioperative period.

  From the point of randomisation until 90± 7 days following the surgical procedure.

• The score measuring the quality of life after surgery.

  From the point of randomisation until 90± 7 days following the surgical procedure.

Study Arms (2)

Combined Iron Protocols group（CIP group）

EXPERIMENTAL

Preoperative randomization was conducted, followed by a three-day regimen in the week preceding surgery, involving the administration of intravenous iron sucrose at a dosage of 200 mg per day, vitamin C at a dosage of 2 g per day, and subcutaneous administration of Human Erythropoietin Injection at a dosage of 150 IU per kilogram.

Drug: Iron sucrose, Human Erythropoietin Injection, Vitamin C

Standard Medical Care group（SMC group）

ACTIVE COMPARATOR

Standard Medical Care (SMC) for the treatment of IDA. SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).

Drug: Standard Medical Care

Interventions

Iron sucrose, Human Erythropoietin Injection, Vitamin C DRUG

The participants were administered a combined iron supplementation regimen consisting of iron sucrose,Human Erythropoietin Injection, and vitamin C, three times throughout the preoperative week.

Combined Iron Protocols group（CIP group）

Standard Medical Care DRUG

Standard Medical Care (SMC) for the treatment of IDA. SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).

Standard Medical Care group（SMC group）

Eligibility Criteria

• Age: 18 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 Wenzhou Medical University: collaborator
• Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University: collaborator
• The Central Hospital of Lishui City: collaborator
• First Affiliated Hospital of Chongqing Medical University: collaborator
• Zhejiang Provincial People's Hospital: collaborator
• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: collaborator
• Zhejiang University: collaborator
• Nanjing Hospital affiliated hospital of Nanjing medicine University: collaborator

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University anesthesiology department

Hangzhou, Zhejiang, 310000, 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; Anemia, Iron-Deficiency

Interventions

Ferric Oxide, Saccharated; Ascorbic Acid

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Hypochromic; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: August 25, 2023
• Study Start: January 4, 2025
• Primary Completion: January 31, 2026
• Study Completion: March 31, 2026
• Last Updated: April 16, 2025

Record last verified: 2025-01

Locations

CN (1)