Short-term Intravenous Iron Isomaltose Anhydride for IDA

NCT03915327 | Not Yet Recruiting DMC

• 1 other identifier: WCH20190308
• Study Type: interventional
• Target: 1,600
• Locations: 0 countries
• Sites: N/A

Brief Summary

This prospective, randomized, controlled study aims to evaluate the impact of short-term intravenous iron isomaltose anhydride on postoperative recovery and the requirement for allogeneic red blood cells (RBC) transfusion in preoperative Iron-deficiency anemia (IDA) patients receiving orthopedic surgery, thus facilitating developing a simple and effective iron supplement approach for patients' recovery.

Conditions

Iron Deficiency Anemia

Keywords

Iron-deficiency anemia; Intravenous iron isomaltose anhydride; Preoperative

Outcome Measures

Primary Outcomes (1)

• Rate of allogeneic RBC transfusion

  Number of patients who receive allogeneic RBC transfusion/total number of patients.

  30 days after randomization

Secondary Outcomes (8)

• Average number of units of RBC transfused in patients who receive allogeneic RBC transfusion

  30 days after randomization

• Average number of units of RBC transfused in the entire study population

  30 days after randomization

• Incidence of postoperative adverse events (AEs)

  30 days after randomization

• Hemoglobin (Hb) levels

  30 days after randomization

• Length of stay (LOS)

  30 days after randomization

Study Arms (2)

Intravenous iron group

EXPERIMENTAL

Enrolled subjects would receive intravenous iron isomaltose anhydride within 24 hours of the subject's inclusion.

Drug: Intravenous iron isomaltose anhydride

Control group

NO INTERVENTION

Clinical management, including surgical procedures, anesthesia, and perioperative management, are performed in accordance with standard clinical practice.

Interventions

Intravenous iron isomaltose anhydride DRUG

Enrolled subjects would receive intravenous iron isomaltose anhydride within 24 hours of the subject's inclusion.

Intravenous iron group

Eligibility Criteria

• Age: 14 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 14 years;
• Sign and date the "informed consent form"

You may not qualify if:

• Pregnant or lactation;
• Drug abuse, including but not limited to opioids, amphetamines, ice, ketamine, etc.;
• History of anaphylaxis to oral or intravenous iron;
• Nervous system diseases such as peripheral neuropathy, mental illness;
• Other conditions that the investigator deems are not suitable for the study, such as deafness, Parkinson's disease, communication disorders, etc.;
• Participated in other clinical trials during the first three months of the study.

Sponsors & Collaborators

• West China Hospital: lead

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

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

Study Officials

• Ren Liao, M.D.

  Department of Anesthesiology, West China Hospital, Sichuan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ren Liao, M.D.

CONTACT

+86-18980602177; liaoren7733@163.com

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: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 31, 2019
• First Posted: April 16, 2019
• Study Start: July 5, 2024
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2029
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: From May 01,2023, for 10 years.
• Access Criteria: Contact with Dr. Ren Liao by email: liaoren7733@163.com