The Effects of Ferric Derisomaltose on Postoperative Anemia in Spinal Deformity Surgery

Surgery Clinical Trial

Official title:

The Effects of Ferric Derisomaltose on Postoperative Anemia in Patients Undergoing Spinal Deformity Surgery: A Prospective Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05714007
• Other study ID #: PUMCH-Fe
• Status: Recruiting
• Phase: Phase 4
• Start date: August 31, 2023
• Est. completion date: June 2025

Study information

• Verified date: September 2023
• Source: Peking Union Medical College Hospital
• Contact: Jianxiong Shen, MD
• Phone: 01069152701
• Email: sjxpumch[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

1. Age =18 years

2. Received spinal deformity surgery

3. 70 g/L = Hb = 110 g/L at POD1, or Hb =120 g/L at POD1 with a decrease in Hb 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.

Related Conditions & MeSH terms

• Adult
• Anemia
• Congenital Abnormalities
• Perioperative Anemia
• Spinal Deformity
• Surgery

Intervention

Drug:
• Ferric derisomaltose
Single intravenous dose ferric derisomaltose
• Ferrous succinate
Daily oral dose of 100 mg iron (ferrous succinate) tid postoperatively

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Pharmacosmos A/S

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hemoglobin concentration	Change in hemoglobin concentrations from POD(postoperative day)1 to POD14	At 14 days
Secondary	Change in hemoglobin concentration	Change in hemoglobin concentrations from POD1 to POD5	At 5 days
Secondary	Change in hemoglobin concentration	Change in hemoglobin concentrations from POD1 to POD35	At 35 days
Secondary	Correction of anemia	The percentage of effective correction of anemia (elevation of Hb >20g/L or Hb =120g/L) at POD5	At 5 days
Secondary	Correction of anemia	The percentage of effective correction of anemia (elevation of Hb >20g/L or Hb =120g/L) at POD14	At 14 days
Secondary	Correction of anemia	The percentage of effective correction of anemia (elevation of Hb >20g/L or Hb =120g/L) at POD35	At 35 days
Secondary	Change in serum iron	Change in serum iron from POD1 to POD5	At 5 days
Secondary	Change in serum iron	Change in serum iron from POD1 to POD14	At 14 days
Secondary	Change in serum iron	Change in serum iron from POD1 to POD35	At 35 days
Secondary	Change in ferritin	Change in ferritin from POD1 to POD5	At 5 days
Secondary	Change in ferritin	Change in ferritin from POD1 to POD14	At 14 days
Secondary	Change in ferritin	Change in ferritin from POD1 to POD35	At 35 days
Secondary	Change in transferrin saturation	Change in transferrin saturation from POD1 to POD5	At 5 days
Secondary	Change in transferrin saturation	Change in transferrin saturation from POD1 to POD14	At 14 days
Secondary	Change in transferrin saturation	Change in transferrin saturation from POD1 to POD35	At 35 days
Secondary	Change in soluble transferrin receptor	Change in soluble transferrin receptor from POD1 to POD5	At 5 days
Secondary	Change in soluble transferrin receptor	Change in soluble transferrin receptor from POD1 to POD14	At 14 days
Secondary	Change in soluble transferrin receptor	Change in soluble transferrin receptor from POD1 to POD35	At 35 days
Secondary	EQ-5D	Quality of life measured by EQ-5D (European Quality of Life-5 Dimensions) at POD5	At 5 days
Secondary	EQ-5D	Quality of life measured by EQ-5D at POD14	At 14 days
Secondary	EQ-5D	Quality of life measured by EQ-5D at POD35	At 35 days
Secondary	Fatigue score	Fatigue measured FACIT-F (The Functional Assessment of Chronic Illness Therapy-Fatigue) questionnaire at POD5	At 5 days
Secondary	Fatigue score	Fatigue measured FACIT-F questionnaire at POD14	At 14 days
Secondary	Fatigue score	Fatigue measured FACIT-F questionnaire at POD35	At 35 days
Secondary	Barthel Index	Independence in daily activities measured by the Barthel questionnaire at POD 5	At 5 days
Secondary	Barthel Index	Independence in daily activities measured by the Barthel questionnaire at POD 14	At 14 days
Secondary	Barthel Index	Independence in daily activities measured by the Barthel questionnaire at POD 35	At 35 days
Secondary	Length of hospital stay	Hospitalized days	At 3 months
Secondary	Adverse events	Incidence of adverse events	At 3 months
Secondary	Infection	Incidence of postoperative infection	At 3 months