The Effect of Combined Iron Protocols on Perioperative Allogeneic Transfusion

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

Interventions

DRUG

Iron sucrose, Human Erythropoietin Injection, Vitamin C

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.

DRUG

Standard Medical Care

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

Sponsors & Collaborators

• First Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

  collaborator OTHER

• The Central Hospital of Lishui City

  collaborator OTHER

• First Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• Zhejiang Provincial People's Hospital

  collaborator OTHER

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine

  collaborator OTHER

• Zhejiang University

  collaborator OTHER

• Nanjing Hospital affiliated hospital of Nanjing medicine University

  collaborator UNKNOWN

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-04

Primary Completion

2026-01-31

Completion

2026-03-31

Countries

• China

Study Locations