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

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Jan 26, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how a treatment called ferric derisomaltose, given through an intravenous (IV) injection, can help improve anemia after spinal deformity surgery. Anemia is a condition where you don’t have enough healthy red blood cells, which can make it harder for patients to recover after surgery. In this study, some participants will receive the IV treatment, while others will take iron supplements by mouth. Researchers will compare how well each method works by checking changes in blood levels, how much anemia is corrected, and overall patient well-being.

To participate in this trial, you need to be at least 18 years old and have undergone spinal deformity surgery. You should also have certain levels of hemoglobin, a protein in your blood that carries oxygen, after surgery. However, if you are pregnant, breastfeeding, or have specific health issues, you may not be eligible to join. If you decide to participate, you will help researchers learn more about whether this new treatment can improve recovery for patients facing similar surgeries in the future.

Gender

ALL

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.