Symptomatic spinal degeneration
Conditions
Interventions
FDI group:Patients in the isomaltose iron group received intravenous infusion of isomaltose iron one day before surgery, with the dosage based on weight assessment (500mg for body weight= 70kg). The s
CON group:Some amount of normal saline on one day before surgery.
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion criteria: (1) Age >= 60 years old; (2) Perform multi segment (>= 2 segments) spinal fusion surgery; (3) The patient signs an informed consent form.
Exclusion criteria
Exclusion criteria: Exclusion criteria: (1) Iron overload or iron utilization disorders (such as hemochromatosis, hemochromatosis containing iron); (2) There are various types of anemia at baseline (Hb3 times the upper limit of normal]; (5) Acute or chronic infectious diseases; (6) Patients with immune or inflammatory diseases (such as systemic lupus erythematosus, rheumatoid arthritis); (7) Hypersensitivity reactions occur to active ingredients, isomaltulose iron injection, and any excipients; (8) Known to have experienced severe hypersensitivity reactions to other parenteral iron agents; (9) Used iron therapy within 3 months before surgery; (10) Three months prior to surgery, red blood cell stimulating agents were used; (11) History of blood transfusion within one month prior to surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin levels at 4 weeks postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hemoglobin levels at baseline, postoperative 1 day, 3 days, and 1 week;The incidence of anemia at discharge and 4 weeks after surgery (anemia definition: male hemoglobin<13g/dL, female hemoglobin<12g/dL);Baseline, postoperative 1 day, 3 days, 1 week, and 4 weeks iron metabolism indicators (iron, ferritin, and transferrin saturation);Allogeneic transfusion rate and mean amount of allogeneic transfusion (unit IU);Length of postoperative stay;Postoperative drainage time, daily drainage volume, and total drainage volume;At baseline and four weeks after surgery, patient satisfaction was assessed using the Likert scale, and quality of life was evaluated using the Five Dimensional Health Scale (EQ-5D); | — |
Countries
China
Contacts
Public ContactHaolin Sun
Peking University First Hospital
Outcome results
None listed