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New treatment option for Perioperative Anemia
Official title The Effects of Ferric Derisomaltose on Postoperative Anemia in Spinal Deformity Surgery
ClinicalTrials.gov ID: NCT05714007
What this study is testing
What is Ferric derisomaltose?
Ferric derisomaltose is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for perioperative anemia.
Also referred to as MONOFER®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years
- Received spinal deformity surgery
- 70 g/L ≤ Hb ≤ 110 g/L at POD1, or Hb at POD1 showed a decrease of ≥20 g/L compared with baseline
- Informed consent was obtained voluntarily
You likely can't join if
- Women who are pregnant, breastfeeding, or planning to become pregnant.
- known serious hypersensitivity to other parenteral iron products
- Non-iron deficiency anemia (e.g., hemolytic anemia)
- Decompensated liver insufficiency
- Coexisting active infection
- Drug abuse, including but not limited to opioids, amphetamines, methamphetamine, ketamine, etc.
See the full eligibility criteria
- Age ≥18 years
- Received spinal deformity surgery
- 70 g/L ≤ Hb ≤ 110 g/L at POD1, or Hb at POD1 showed a decrease of ≥20 g/L compared with baseline
- Informed consent was obtained voluntarily
- Women who are pregnant, breastfeeding, or planning to become pregnant.
- known serious hypersensitivity to other parenteral iron products
- Non-iron deficiency anemia (e.g., hemolytic anemia)
- Decompensated liver insufficiency
- Coexisting active infection
- Drug abuse, including but not limited to opioids, amphetamines, methamphetamine, ketamine, etc.
- Other conditions that the investigator considers inappropriate for participation (e.g. deafness, Parkinson's disease, communication disorders, etc.)
- Participation in another clinical trial within three months prior to this study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.