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
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
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
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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