Health TrialsbyHealthPanel

Short-term Intravenous Iron Isomaltose Anhydride for IDA

ConditionIron Deficiency Anemia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-99
SponsorWest China Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 14 years;

Sign and date the "informed consent form"

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intravenous iron isomaltose anhydride

    Drug

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

Treatment groups

1,600 Participants
are divided into 2 treatment groups
Group A: Intravenous iron groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Rate of allogeneic RBC transfusion

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

Time frame
30 days after randomization

Secondary outcomes

1

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

Time frame
30 days after randomization
2

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

Total number of units of RBC transfused/total number of patients

Time frame
30 days after randomization
3

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

Time frame
30 days after randomization
4

Hemoglobin (Hb) levels

Hemoglobin (Hb) levels at different time points;

Time frame
30 days after randomization

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

West China Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: