The prognosis of patients undergoing spinal deformity surgery is often compromised by perioperative anemia due to iron deficiency. The aim of this randomized, controlled trial was to evaluate whether postoperative ferric derisomaltose intravenous injection may improve anemia and prognosis in patients undergoing spinal deformity surgery comparing with oral iron. Participants will be randomly assigned to the treatment group (intravenous ferric derisomaltose) and the control group (oral iron). Changes in hemoglobin concentration, percentage of anemia correction, changes in iron indicators, patient quality of life, and incidence of adverse events will be analyzed to evaluate the efficacy and safety of iron isomaltoside infusion.
Iron deficiency is a common cause of perioperative anemia in patients undergoing spinal deformity surgery. Anemia may lead to increased postoperative complications and mortalities, prolonged hospital stays, deteriorated physical function, and severely affect the quality of life. Oral iron has been widely recommended to treat perioperative anemia. However, the pro-inflammatory cytokines (such as IL-6 (Interleukin-6), TNF-a (Tumor necrosis factor-α)) produced by the inflammatory state after surgery can lead to an increase in hepcidin, which greatly affects the absorption of oral iron. Compared to oral iron, intravenous iron can circumvent the effects of decreased iron absorption in the gastrointestinal tract due to the postoperative inflammatory state and achieve faster and more effective iron supplementation. At present, intravenous iron supplements are mainly second-generation products, including iron sucrose and ferric gluconate. However, the unstable molecular structure of second-generation iron supplements may cause oxidative stress, which limits its administration in large doses. Compared with traditional intravenous iron, the third-generation iron preparations allow more iron (1000 mg (milligram) or more, no more than 20 mg/kg (kilogram)) to be infused within a short period of time (15-60 minutes), improving patient compliance, reducing costs and complications caused by multiple infusions, and is promising to improve anemia more rapidly. Ferric derisomaltose, as the only third-generation iron currently available in China market, has showed its value in treating anemia in joint replacement surgeries. However, the effectiveness of postoperative intravenous ferric derisomaltose in spinal deformity surgery remains uncertain. Therefore, we designed this prospective randomized trial to evaluate whether intravenous ferric derisomaltose may improve anemia and prognosis in patients undergoing spinal deformity surgery compared with oral iron.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
Single intravenous dose ferric derisomaltose
Daily oral dose of 100 mg iron (ferrous succinate) tid postoperatively
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGChange in hemoglobin concentration
Change in hemoglobin concentrations from POD(postoperative day)1 to POD14
Time frame: At 14 days
Change in hemoglobin concentration
Change in hemoglobin concentrations from POD1 to POD5
Time frame: At 5 days
Change in hemoglobin concentration
Change in hemoglobin concentrations from POD1 to POD35
Time frame: At 35 days
Correction of anemia
The percentage of effective correction of anemia (elevation of Hb \>20g/L or Hb ≥120g/L) at POD5
Time frame: At 5 days
Correction of anemia
The percentage of effective correction of anemia (elevation of Hb \>20g/L or Hb ≥120g/L) at POD14
Time frame: At 14 days
Correction of anemia
The percentage of effective correction of anemia (elevation of Hb \>20g/L or Hb ≥120g/L) at POD35
Time frame: At 35 days
Change in serum iron
Change in serum iron from POD1 to POD5
Time frame: At 5 days
Change in serum iron
Change in serum iron from POD1 to POD14
Time frame: At 14 days
Change in serum iron
Change in serum iron from POD1 to POD35
Time frame: At 35 days
Change in ferritin
Change in ferritin from POD1 to POD5
Time frame: At 5 days
Change in ferritin
Change in ferritin from POD1 to POD14
Time frame: At 14 days
Change in ferritin
Change in ferritin from POD1 to POD35
Time frame: At 35 days
Change in transferrin saturation
Change in transferrin saturation from POD1 to POD5
Time frame: At 5 days
Change in transferrin saturation
Change in transferrin saturation from POD1 to POD14
Time frame: At 14 days
Change in transferrin saturation
Change in transferrin saturation from POD1 to POD35
Time frame: At 35 days
Change in soluble transferrin receptor
Change in soluble transferrin receptor from POD1 to POD5
Time frame: At 5 days
Change in soluble transferrin receptor
Change in soluble transferrin receptor from POD1 to POD14
Time frame: At 14 days
Change in soluble transferrin receptor
Change in soluble transferrin receptor from POD1 to POD35
Time frame: At 35 days
EQ-5D
Quality of life measured by EQ-5D (European Quality of Life-5 Dimensions) at POD5
Time frame: At 5 days
EQ-5D
Quality of life measured by EQ-5D at POD14
Time frame: At 14 days
EQ-5D
Quality of life measured by EQ-5D at POD35
Time frame: At 35 days
Fatigue score
Fatigue measured FACIT-F (The Functional Assessment of Chronic Illness Therapy-Fatigue) questionnaire at POD5
Time frame: At 5 days
Fatigue score
Fatigue measured FACIT-F questionnaire at POD14
Time frame: At 14 days
Fatigue score
Fatigue measured FACIT-F questionnaire at POD35
Time frame: At 35 days
Barthel Index
Independence in daily activities measured by the Barthel questionnaire at POD 5
Time frame: At 5 days
Barthel Index
Independence in daily activities measured by the Barthel questionnaire at POD 14
Time frame: At 14 days
Barthel Index
Independence in daily activities measured by the Barthel questionnaire at POD 35
Time frame: At 35 days
Length of hospital stay
Hospitalized days
Time frame: At 3 months
Adverse events
Incidence of adverse events
Time frame: At 3 months
Infection
Incidence of postoperative infection
Time frame: At 3 months
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