Clinical trial NCT05714007: The Effects of Ferric Derisomaltose on Postoperative Anemia in Spinal Deformity Surgery
Official title: The Effects of Ferric Derisomaltose on Postoperative Anemia in Patients Undergoing Spinal Deformity Surgery: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Perioperative Anemia
Surgery
Spinal Deformity
Adult
Keywords: spinal deformity surgery
perioperative anemia
ferric derisomaltose
adult
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Pharmacosmos A/S
First posted: 2023-02-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria

1. Age ≥18 years
2. Received spinal deformity surgery
3. 70 g/L ≤ Hb ≤ 110 g/L at POD1, or Hb at POD1 showed a decrease of

   ≥20 g/L compared with baseline
4. Informed consent was obtained voluntarily

Exclusion Criteria

1. Women who are pregnant, breastfeeding, or planning to become pregnant.
2. known serious hypersensitivity to other parenteral iron products
3. Non-iron deficiency anemia (e.g., hemolytic anemia)
4. Decompensated liver insufficiency
5. Coexisting active infection
6. Drug abuse, including but not limited to opioids, amphetamines, methamphetamine, ketamine, etc.
7. Other conditions that the investigator considers inappropriate for participation (e.g. deafness, Parkinson's disease, communication disorders, etc.)
8. Participation in another clinical trial within three months prior to this study.

Primary outcomes:
measure: Change in hemoglobin concentration
timeFrame: At 14 days
Secondary outcomes:
measure: Change in hemoglobin concentration
timeFrame: At 5 days
measure: Change in hemoglobin concentration
timeFrame: At 35 days
measure: Correction of anemia
timeFrame: At 5 days
measure: Correction of anemia
timeFrame: At 14 days
measure: Correction of anemia
timeFrame: At 35 days
measure: Change in serum iron
timeFrame: At 5 days
measure: Change in serum iron
timeFrame: At 14 days
measure: Change in serum iron
timeFrame: At 35 days
measure: Change in ferritin
timeFrame: At 5 days
measure: Change in ferritin
timeFrame: At 14 days
measure: Change in ferritin
timeFrame: At 35 days
measure: Change in transferrin saturation
timeFrame: At 5 days
measure: Change in transferrin saturation
timeFrame: At 14 days
measure: Change in transferrin saturation
timeFrame: At 35 days
measure: Change in soluble transferrin receptor
timeFrame: At 5 days
measure: Change in soluble transferrin receptor
timeFrame: At 14 days
measure: Change in soluble transferrin receptor
timeFrame: At 35 days
measure: EQ-5D
timeFrame: At 5 days
measure: EQ-5D
timeFrame: At 14 days
measure: EQ-5D
timeFrame: At 35 days
measure: Fatigue score
timeFrame: At 5 days
measure: Fatigue score
timeFrame: At 14 days
measure: Fatigue score
timeFrame: At 35 days
measure: Barthel Index
timeFrame: At 5 days
measure: Barthel Index
timeFrame: At 14 days
measure: Barthel Index
timeFrame: At 35 days
measure: Length of hospital stay
timeFrame: At 3 months
measure: Adverse events
timeFrame: At 3 months
measure: Infection
timeFrame: At 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Weiyun Chen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking Union Medical College Hospital
name: Jianxiong Shen, MD
role: STUDY_DIRECTOR
References:
citation: Zhan J, Jiao Y, Chen W, Huang Y, Shen J. Effects of ferric derisomaltose on postoperative anaemia in adult spinal deformity surgery: a study protocol for a randomised controlled trial. BMJ Open. 2024 Jan 24;14(1):e080952. doi: 10.1136/bmjopen-2023-080952.