Effects of ferric derisomaltose on postoperative anaemia in adult spinal deformity surgery: a study protocol for a randomised controlled trial.
Jing Zhan, Yang Jiao, Weiyun Chen...
https://pubmed.ncbi.nlm.nih.gov/38267243Actively Recruiting
Phase 4
Age: 18Years +
All Genders
ID05714007
The Effects of Ferric Derisomaltose on Postoperative Anemia in Patients Undergoing Spinal Deformity Surgery: A Prospective Randomized Controlled Study
Led by Peking Union Medical College Hospital · Updated on 2025-06-13
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
P
Peking Union Medical College Hospital
Lead Sponsor
P
Pharmacosmos A/S
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of intravenous ferric derisomaltose compared with oral iron on postoperative anemia in adults undergoing spinal deformity surgery. This trial aims to improve anemia management and patient prognosis by comparing these two iron supplementation methods, considering that anemia due to iron deficiency often worsens outcomes after such surgeries. The study is a prospective, randomized, controlled trial designed to assess efficacy and safety in this context. Participants will be randomly assigned to receive either a single intravenous dose of ferric derisomaltose or daily oral ferrous succinate tablets for four weeks starting the day after surgery. The intravenous dose varies by body weight and hemoglobin levels, with a maximum dose not exceeding 20 mg/kg. The oral iron is taken three times daily. This approach allows comparison between the faster, potentially more effective intravenous method and the more traditional oral treatment. During the study, participants will have their hemoglobin levels and iron-related indicators measured at multiple time points, including 5, 14, and 35 days after surgery. Quality of life, fatigue, and physical function will also be assessed through questionnaires and indices. Safety monitoring includes tracking adverse events and infections up to three months. The primary outcome is the change in hemoglobin concentration at 14 days postoperatively, with additional secondary outcomes evaluated at various intervals. Total participation spans at least three months to monitor recovery and safety.
CONDITIONS
Brief Title
The Effects of Ferric Derisomaltose on Postoperative Anemia in Spinal Deformity Surgery
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Underwent spinal deformity surgery
- Hemoglobin 70 to 110 g/L on first postoperative day or a drop of 20 g/L or more compared to baseline
- Provided voluntary informed consent
You will not qualify if you...
- Women who are pregnant, breastfeeding, or planning pregnancy
- Known serious allergy to intravenous iron products
- Anemia not caused by iron deficiency (e.g., hemolytic anemia)
- Decompensated liver failure
- Active infection at the time of enrollment
- History of drug abuse including opioids, amphetamines, methamphetamine, ketamine
- Other conditions unsuitable for participation such as deafness, Parkinson's disease, communication disorders
- Participation in another clinical trial within the previous three months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 4 weeks
Participants receive either a single intravenous dose of ferric derisomaltose or daily oral ferrous succinate tablets three times a day starting the first postoperative day and continuing for 4 weeks to treat postoperative anemia.
1 baseline visit and multiple visits for assessments up to 5 weeks
Follow-up
Duration - Up to 3 months
Participants are monitored for hemoglobin changes, anemia correction, iron levels, quality of life, fatigue, and adverse events for up to 3 months after treatment to evaluate longer-term outcomes.
Visits at 14 days, 35 days, and 3 months post-treatment
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
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Research Team
J
Jianxiong Shen, MD
W
Weiyun Chen, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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