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Short-term Intravenous Iron Isomaltose Anhydride for IDA

Primary Purpose

Iron Deficiency Anemia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intravenous iron isomaltose anhydride
Sponsored by
West China Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iron Deficiency Anemia focused on measuring Iron-deficiency anemia, Intravenous iron isomaltose anhydride, Preoperative

Eligibility Criteria

14 Years - 99 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intravenous iron group

    Control group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Average number of units of RBC transfused in patients who receive allogeneic RBC transfusion
    Total number of units of RBC transfused/number of patients who receive allogeneic RBC transfusion
    Average number of units of RBC transfused in the entire study population
    Total number of units of RBC transfused/total number of patients
    Incidence of postoperative adverse events (AEs)
    AEs are graded according to the severity: Grade 1 Recovery after temporary treatment, such as postoperative nausea and vomiting (PONV), urinary retention, anxiety, temporary insomnia, etc. Grade 2 Results in prolonged hospitalization, such as lung infections requiring antibiotic treatment, incision infections requiring debridement treatment, etc.; Grade 3 life-threatening, recovery after treatment during hospitalization, such as acute renal failure requiring renal replacement therapy, postoperative hemorrahge requiring surgical intervention, respiratory failure requiring mechanical ventilation, etc.; Grade 4 Injury last 30 days or more after surgery, a significant decrease in the quality of life, such as acute myocardial infarction, stroke, etc.; Grade 5 Death with 30 days after surgery
    Hemoglobin (Hb) levels
    Hemoglobin (Hb) levels at different time points;
    Length of stay (LOS)
    Length of stay (LOS), defined as number of days from admission to discharge
    Postoperative hospital stay
    Number of days from the day of surgery to discharge
    Re-admission
    Re-admission within 30 days after surgery
    Cost of Hospitalization
    Total cost of hospitalization from admission to discharge.

    Full Information

    First Posted
    March 31, 2019
    Last Updated
    February 19, 2022
    Sponsor
    West China Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03915327
    Brief Title
    Short-term Intravenous Iron Isomaltose Anhydride for IDA
    Official Title
    Short-term Use of Intravenous Iron Isomaltose Anhydride for Preoperative Anemic Patients Undergoing Orthopedic Surgery: a Prospective, Randomized, Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 5, 2022 (Anticipated)
    Primary Completion Date
    May 31, 2023 (Anticipated)
    Study Completion Date
    May 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    West China Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    Anemia is a decrease in the concentration of hemoglobin (Hb) or RBC count in the blood ting, causing body not being able to adequately supply oxygen to tissues and cells. Preoperative anemia is common in patients receiving elective surgery, with a prevalence ranging from 5% to 75%. For instance, the prevalence of anemia before total hip or total knee arthroplasty is around 35%. Preoperative anemia is one of the main predictors of perioperative allogeneic RBC transfusion, and is closely associated with postoperative infection, increased morbidity and mortality, prolonged hospital stay, and decreased quality of life. As the world enters an aging society, the proportion of elderly patients receiving surgery, especially orthopedic surgery, is increasing. There are 3 main causes of anemia in the elderly: nutritional anemia (~34%), which is caused by lack of hematopoietic materials. Iron-deficiency anemia (IDA) is the most common type of nutritional anemia, while megaloblastic anemia caused by lack of folic acid and vitamin B12 is relatively rare. Anemia of chronic disease (~32%), which is characterized by disorders of iron metabolism that occurs in certain chronic diseases, such as persistent infections, inflammation and tumors. Anemia of unknown cause (-34%), which may involve multifactorial pathogenic mechanisms and comorbidities. IDA, the most common cause of perioperative anemia in patients receiving orthopedic surgery, is a condition caused by hematopoietic materials deficiency and has a good clinical response to iron supplementation with a rapid rise of Hb level. Iron supplementation in patients with preoperative IDA, or insufficient iron intake and excessive loss is able to improve the patients' surgical tolerance and reduce the transfusion rate; For anemic patients with acute blood loss during surgery, iron supplementation is able to accelerate anemia correction, thus enhancing postoperative recovery and shortening length of hospital stay. Iron therapy can be administrated by the oral or intravenous route. Absorption of oral iron therapy is relatively low, and it usually takes over 1 to 2 months to correct the iron deficiency status. Therefore, intravenous iron therapy is recommended for patients diagnosed with IDA after admission to hospital to receive surgery. Intravenous iron therapy was originally the standard iron supplementation in chronic renal failure patients with IDA. Subsequently, it was expanded to the anemia of patients with conventional inflammatory bowel disease for its desirable efficacy. Several studies of elderly IDA patients receiving orthopedic surgery and gynecologic surgery suggest that intravenous iron therapy can rapidly increase hemoglobin levels before surgery, leading to a decrease in blood transfusion rates. The calculation of the total dose of intravenous iron is as follows: = Weight (kg) ×[Target Hb level(g/L)- actual Hb level(g/L)] ×0.24 + 500mg Treatment duration is over 2 weeks in most clinical studies of intravenous iron therapy. In China, few patients are treated with intravenous iron therapy in community hospitals for 2 to 4 weeks before surgery. Therefore, many IDA patients did not receive proper preoperative intravenous iron therapy. Iron isomaltose anhydride, an intravenous iron preparation that can be administered in a single treatment up to 1000 mg in a relatively short (15 minutes) time without need for test dose, is of low risk of adverse reactions. Therefore, sufficient amount of iron can be administrated during preoperative. Currently, there is no evidence to elucidate whether short-term sufficient intravenous iron supplementation can reduce perioperative blood transfusion requirements among IDA patients. Thus, we hypothesized that short-term intravenous administration of sufficient iron isomaltose anhydride can reduce the need for perioperative allogeneic RBC transfusion without increasing the incidence of adverse reactions. This prospective, randomized, controlled study aims to evaluate the impact of short-term (1 week) intravenous iron isomaltose anhydride in preoperative IDA patients receiving orthopedic surgery on postoperative allogeneic RBC transfusion rate and amount, hemoglobin level and iron storage, postoperative complications, average length/expense of hospital stay, etc., to determine the safety and efficacy of short-term sufficient intravenous iron therapy, and to develop a simple and effective preoperative iron supplementation program.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Iron Deficiency Anemia
    Keywords
    Iron-deficiency anemia, Intravenous iron isomaltose anhydride, Preoperative

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    1600 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intravenous iron group
    Arm Type
    Experimental
    Arm Description
    Enrolled subjects would receive intravenous iron isomaltose anhydride within 24 hours of the subject's inclusion.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Clinical management, including surgical procedures, anesthesia, and perioperative management, are performed in accordance with standard clinical practice.
    Intervention Type
    Drug
    Intervention Name(s)
    Intravenous iron isomaltose anhydride
    Intervention Description
    Enrolled subjects would receive intravenous iron isomaltose anhydride within 24 hours of the subject's inclusion.
    Primary Outcome Measure Information:
    Title
    Rate of allogeneic RBC transfusion
    Description
    Number of patients who receive allogeneic RBC transfusion/total number of patients.
    Time Frame
    30 days after randomization
    Secondary Outcome Measure Information:
    Title
    Average number of units of RBC transfused in patients who receive allogeneic RBC transfusion
    Description
    Total number of units of RBC transfused/number of patients who receive allogeneic RBC transfusion
    Time Frame
    30 days after randomization
    Title
    Average number of units of RBC transfused in the entire study population
    Description
    Total number of units of RBC transfused/total number of patients
    Time Frame
    30 days after randomization
    Title
    Incidence of postoperative adverse events (AEs)
    Description
    AEs are graded according to the severity: Grade 1 Recovery after temporary treatment, such as postoperative nausea and vomiting (PONV), urinary retention, anxiety, temporary insomnia, etc. Grade 2 Results in prolonged hospitalization, such as lung infections requiring antibiotic treatment, incision infections requiring debridement treatment, etc.; Grade 3 life-threatening, recovery after treatment during hospitalization, such as acute renal failure requiring renal replacement therapy, postoperative hemorrahge requiring surgical intervention, respiratory failure requiring mechanical ventilation, etc.; Grade 4 Injury last 30 days or more after surgery, a significant decrease in the quality of life, such as acute myocardial infarction, stroke, etc.; Grade 5 Death with 30 days after surgery
    Time Frame
    30 days after randomization
    Title
    Hemoglobin (Hb) levels
    Description
    Hemoglobin (Hb) levels at different time points;
    Time Frame
    30 days after randomization
    Title
    Length of stay (LOS)
    Description
    Length of stay (LOS), defined as number of days from admission to discharge
    Time Frame
    30 days after randomization
    Title
    Postoperative hospital stay
    Description
    Number of days from the day of surgery to discharge
    Time Frame
    30 days after randomization
    Title
    Re-admission
    Description
    Re-admission within 30 days after surgery
    Time Frame
    30 days after randomization
    Title
    Cost of Hospitalization
    Description
    Total cost of hospitalization from admission to discharge.
    Time Frame
    30 days after randomization

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age > 14 years; Sign and date the "informed consent form" Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ren Liao, M.D.
    Phone
    +86-18980602177
    Email
    liaoren7733@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ren Liao, M.D.
    Organizational Affiliation
    Department of Anesthesiology, West China Hospital, Sichuan University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Individual participant data could be accessed under request to Dr. Ren Liao by email: liaoren7733@163.com
    IPD Sharing Time Frame
    From May 01,2023, for 10 years.
    IPD Sharing Access Criteria
    Contact with Dr. Ren Liao by email: liaoren7733@163.com

    Learn more about this trial

    Short-term Intravenous Iron Isomaltose Anhydride for IDA

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