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Short-term Intravenous Iron Dextran for IDA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03915327
Recruitment Status : Not yet recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Ren Liao, West China Hospital

Brief Summary:
This prospective, randomized, controlled study aims to evaluate the impact of short-term intravenous iron dextran 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.

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Drug: Intravenous iron dextran Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Short-term Use of Intravenous Iron Dextran for Preoperative Anemic Patients Undergoing Orthopedic Surgery: a Prospective, Randomized, Controlled Study
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : May 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Experimental: Intravenous iron group
Enrolled subjects would receive intravenous iron dextran within 24 hours of the subject's inclusion.
Drug: Intravenous iron dextran
Enrolled subjects would receive intravenous iron dextran within 24 hours of the subject's inclusion.

No Intervention: Control group
Clinical management, including surgical procedures, anesthesia, and perioperative management, are performed in accordance with standard clinical practice.



Primary Outcome Measures :
  1. Rate of allogeneic RBC transfusion [ Time Frame: 30 days after randomization ]
    Number of patients who receive allogeneic RBC transfusion/total number of patients.


Secondary Outcome Measures :
  1. Average number of units of RBC transfused in patients who receive allogeneic RBC transfusion [ Time Frame: 30 days after randomization ]
    Total number of units of RBC transfused/number of patients who receive allogeneic RBC transfusion

  2. Average number of units of RBC transfused in the entire study population [ Time Frame: 30 days after randomization ]
    Total number of units of RBC transfused/total number of patients

  3. Incidence of postoperative adverse events (AEs) [ Time Frame: 30 days after randomization ]

    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


  4. Hemoglobin (Hb) levels [ Time Frame: 30 days after randomization ]
    Hemoglobin (Hb) levels at different time points;

  5. Length of stay (LOS) [ Time Frame: 30 days after randomization ]
    Length of stay (LOS), defined as number of days from admission to discharge

  6. Postoperative hospital stay [ Time Frame: 30 days after randomization ]
    Number of days from the day of surgery to discharge

  7. Re-admission [ Time Frame: 30 days after randomization ]
    Re-admission within 30 days after surgery

  8. Cost of Hospitalization [ Time Frame: 30 days after randomization ]
    Total cost of hospitalization from admission to discharge.



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Ages Eligible for Study:   14 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915327


Contacts
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Contact: Ren Liao, M.D. +86-18980602177 liaoren7733@163.com

Sponsors and Collaborators
West China Hospital
Investigators
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Principal Investigator: Ren Liao, M.D. Department of Anesthesiology, West China Hospital, Sichuan University
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Responsible Party: Ren Liao, Associate Professor, West China Hospital
ClinicalTrials.gov Identifier: NCT03915327    
Other Study ID Numbers: WCH20190308
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Ren Liao, West China Hospital:
Iron-deficiency anemia
Intravenous iron dextran
Preoperative
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Dextrans
Iron-Dextran Complex
Anticoagulants
Plasma Substitutes
Blood Substitutes
Hematinics