The Effects of Ferric Derisomaltose on Postoperative Anemia in Spinal Deformity Surgery
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking Union Medical College Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Received spinal deformity surgery
70 g/L ≤ Hb ≤ 110 g/L at POD1, or Hb at POD1 showed a decrease of
Informed consent was obtained voluntarily
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Ferric derisomaltose
DrugSingle intravenous dose ferric derisomaltose
Ferrous succinate
DrugDaily oral dose of 100 mg iron (ferrous succinate) tid postoperatively
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Treatment groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in hemoglobin concentration
Change in hemoglobin concentrations from POD(postoperative day)1 to POD14
Time frame
At 14 daysSecondary outcomes
1
Change in hemoglobin concentration
Change in hemoglobin concentrations from POD1 to POD5
Time frame
At 5 days2
Change in hemoglobin concentration
Change in hemoglobin concentrations from POD1 to POD35
Time frame
At 35 days3
Correction of anemia
The percentage of effective correction of anemia (elevation of Hb \>20g/L or Hb ≥120g/L) at POD5
Time frame
At 5 days4
Correction of anemia
The percentage of effective correction of anemia (elevation of Hb \>20g/L or Hb ≥120g/L) at POD14
Time frame
At 14 daysSponsors and contacts
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Peking Union Medical College Hospital
Lead sponsor
Pharmacosmos A/S
Collaborator
Source ClinicalTrials.gov