Actively Recruiting
The Effects of Ferric Derisomaltose on Postoperative Anemia in Spinal Deformity Surgery
Led by Peking Union Medical College Hospital · Updated on 2025-06-13
120
Participants Needed
1
Research Sites
117 weeks
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
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.
CONDITIONS
Official Title
The Effects of Ferric Derisomaltose on Postoperative Anemia in Spinal Deformity Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Have received spinal deformity surgery
- Hemoglobin level between 70 g/L and 110 g/L on the first day after surgery, or a decrease 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 to become pregnant
- Known serious hypersensitivity to parenteral iron products
- Non-iron deficiency anemia such as hemolytic anemia
- Decompensated liver failure
- Active infections
- Drug abuse, including opioids, amphetamines, methamphetamine, or ketamine
- Conditions deemed inappropriate by the investigator (e.g., deafness, Parkinson's disease, communication disorders)
- Participation in another clinical trial within the past three months
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
J
Jianxiong Shen, MD
CONTACT
W
Weiyun Chen, MD
CONTACT
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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