Perioperative AnemiaPhase 4NCT05714007
The Effects of Ferric Derisomaltose on Postoperative Anemia in Spinal Deformity Surgery
A Phase 4 study testing Ferric derisomaltose and Ferrous succinate in people with Perioperative Anemia and Surgery, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative Anemia, Surgery, Spinal Deformity
- What is being tested?
- Ferric derisomaltose and Ferrous succinate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2023to Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Jianxiong Shen, MD, sjxpumch@163.com
About this study
Official title: The Effects of Ferric Derisomaltose on Postoperative Anemia in Patients Undergoing Spinal Deformity Surgery: A Prospective Randomized Controlled Study
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.
Read the detailed description
Iron deficiency is a common cause of perioperative anemia in patients undergoing spinal deformity surgery. Anemia may lead to increased postoperative complications and mortalities, prolonged hospital stays, deteriorated physical function, and severely affect the quality of life.
Oral iron has been widely recommended to treat perioperative anemia. However, the pro-inflammatory cytokines (such as IL-6 (Interleukin-6), TNF-a (Tumor necrosis factor-α)) produced by the inflammatory state after surgery can lead to an increase in hepcidin, which greatly affects the absorption of oral iron. Compared to oral iron, intravenous iron can circumvent the effects of decreased iron absorption in the gastrointestinal tract due to the postoperative inflammatory state and achieve faster and more effective iron supplementation. At present, intravenous iron supplements are mainly second-generation products, including iron sucrose and ferric gluconate. However, the unstable molecular structure of second-generation iron supplements may cause oxidative stress, which limits its administration in large doses.
Compared with traditional intravenous iron, the third-generation iron preparations allow more iron (1000 mg (milligram) or more, no more than 20 mg/kg (kilogram)) to be infused within a short period of time (15-60 minutes), improving patient compliance, reducing costs and complications caused by multiple infusions, and is promising to improve anemia more rapidly. Ferric derisomaltose, as the only third-generation iron currently available in China market, has showed its value in treating anemia in joint replacement surgeries. However, the effectiveness of postoperative intravenous ferric derisomaltose in spinal deformity surgery remains uncertain. Therefore, we designed this prospective randomized trial to evaluate whether intravenous ferric derisomaltose may improve anemia and prognosis in patients undergoing spinal deformity surgery compared with oral iron.
- Conditions
- Perioperative Anemia, Surgery, Spinal Deformity, Adult
- Being tested
- Ferric derisomaltose, Ferrous succinate
- Keywords
- spinal deformity surgery, perioperative anemia, ferric derisomaltose, adult
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric derisomaltoseDrug
Also called MONOFER®
Single intravenous dose ferric derisomaltose
Ferrous succinateDrug
Daily oral dose of 100 mg iron (ferrous succinate) tid postoperatively
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Iron to be administered as intravenous ferric derisomaltose:
Where Hb (hemoglobin) ≥100 g/L, dosage according to body weight is as follows:
Body weight <50 kg: 500mg; Body weight 50 to <70 kg: 1000 mg; Body weight ≥70 kg: 1500 mg.
Where Hb <100 g/L, dosage according to body weight is as follows:
Body weight <50 kg: 500mg; Body weight 50 to <70 kg: 1500mg; Body weight ≥70 kg: 2000 mg.
The maximial dose should not exceed 20mg/kg body weight, rounded off to the nearest 100mg Receives: Drug: Ferric derisomaltose |
| Control group | Active comparator | Iron to be administered as oral ferrous succinate:
1 tablet (100 mg) tid (three times daily), starting on the first postoperative day and continuing for 4 weeks. Receives: Drug: Ferrous succinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin concentration
Change in hemoglobin concentrations from POD(postoperative day)1 to POD14
Measured: At 14 days
Secondary outcomes (29)
Change in hemoglobin concentration
Change in hemoglobin concentrations from POD1 to POD5
Measured: At 5 days
Change in hemoglobin concentration
Change in hemoglobin concentrations from POD1 to POD35
Measured: At 35 days
Correction of anemia
The percentage of effective correction of anemia (elevation of Hb >20g/L or Hb ≥120g/L) at POD5
Measured: At 5 days
Correction of anemia
The percentage of effective correction of anemia (elevation of Hb >20g/L or Hb ≥120g/L) at POD14
Measured: At 14 days
Correction of anemia
The percentage of effective correction of anemia (elevation of Hb >20g/L or Hb ≥120g/L) at POD35
Measured: At 35 days
Change in serum iron
Change in serum iron from POD1 to POD5
Measured: At 5 days
Change in serum iron
Change in serum iron from POD1 to POD14
Measured: At 14 days
Change in serum iron
Change in serum iron from POD1 to POD35
Measured: At 35 days
Change in ferritin
Change in ferritin from POD1 to POD5
Measured: At 5 days
Change in ferritin
Change in ferritin from POD1 to POD14
Measured: At 14 days
Change in ferritin
Change in ferritin from POD1 to POD35
Measured: At 35 days
Change in transferrin saturation
Change in transferrin saturation from POD1 to POD5
Measured: At 5 days
Change in transferrin saturation
Change in transferrin saturation from POD1 to POD14
Measured: At 14 days
Change in transferrin saturation
Change in transferrin saturation from POD1 to POD35
Measured: At 35 days
Change in soluble transferrin receptor
Change in soluble transferrin receptor from POD1 to POD5
Measured: At 5 days
Change in soluble transferrin receptor
Change in soluble transferrin receptor from POD1 to POD14
Measured: At 14 days
Change in soluble transferrin receptor
Change in soluble transferrin receptor from POD1 to POD35
Measured: At 35 days
EQ-5D
Quality of life measured by EQ-5D (European Quality of Life-5 Dimensions) at POD5
Measured: At 5 days
EQ-5D
Quality of life measured by EQ-5D at POD14
Measured: At 14 days
EQ-5D
Quality of life measured by EQ-5D at POD35
Measured: At 35 days
Fatigue score
Fatigue measured FACIT-F (The Functional Assessment of Chronic Illness Therapy-Fatigue) questionnaire at POD5
Measured: At 5 days
Fatigue score
Fatigue measured FACIT-F questionnaire at POD14
Measured: At 14 days
Fatigue score
Fatigue measured FACIT-F questionnaire at POD35
Measured: At 35 days
Barthel Index
Independence in daily activities measured by the Barthel questionnaire at POD 5
Measured: At 5 days
Barthel Index
Independence in daily activities measured by the Barthel questionnaire at POD 14
Measured: At 14 days
Barthel Index
Independence in daily activities measured by the Barthel questionnaire at POD 35
Measured: At 35 days
Length of hospital stay
Hospitalized days
Measured: At 3 months
Adverse events
Incidence of adverse events
Measured: At 3 months
Infection
Incidence of postoperative infection
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start31 Aug 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perioperative AnemiaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmacosmos A/S
- Responsible party
- Principal investigator, Weiyun Chen, Peking Union Medical College Hospital
- Investigators
- Weiyun Chen, MD, Principal investigator, Peking Union Medical College HospitalJianxiong Shen, MD, Study director, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714007
- Sponsor's protocol ID
- PUMCH-Fe
- Status last verified
- Feb 2025
- First submitted
- 26 Jan 2023
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Coded data is anticipated to be shared with potential collaborators.
Publications
Zhan J, Jiao Y, Chen W, Huang Y, Shen J. Effects of ferric derisomaltose on postoperative anaemia in adult spinal deformity surgery: a study protocol for a randomised controlled trial. BMJ Open. 2024 Jan 24;14(1):e080952. doi: 10.1136/bmjopen-2023-080952.
PubMed 38267243
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Ferric Derisomaltose on Postoperative Anemia in Patients Undergoing Spinal Deformity Surgery: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05714007
- Acronym / sponsor ID
- PUMCH-Fe
- Conditions
- Perioperative Anemia, Surgery, Spinal Deformity, Adult
- Keywords
- spinal deformity surgery, perioperative anemia, ferric derisomaltose, adult
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Pharmacosmos A/S
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Iron deficiency is a common cause of perioperative anemia in patients undergoing spinal deformity surgery. Anemia may lead to increased postoperative complications and mortalities, prolonged hospital stays, deteriorated physical function, and severely affect the quality of life.
Oral iron has been widely recommended to treat perioperative anemia. However, the pro-inflammatory cytokines (such as IL-6 (Interleukin-6), TNF-a (Tumor necrosis factor-α)) produced by the inflammatory state after surgery can lead to an increase in hepcidin, which greatly affects the absorption of oral iron. Compared to oral iron, intravenous iron can circumvent the effects of decreased iron absorption in the gastrointestinal tract due to the postoperative inflammatory state and achieve faster and more effective iron supplementation. At present, intravenous iron supplements are mainly second-generation products, including iron sucrose and ferric gluconate. However, the unstable molecular structure of second-generation iron supplements may cause oxidative stress, which limits its administration in large doses.
Compared with traditional intravenous iron, the third-generation iron preparations allow more iron (1000 mg (milligram) or more, no more than 20 mg/kg (kilogram)) to be infused within a short period of time (15-60 minutes), improving patient compliance, reducing costs and complications caused by multiple infusions, and is promising to improve anemia more rapidly. Ferric derisomaltose, as the only third-generation iron currently available in China market, has showed its value in treating anemia in joint replacement surgeries. However, the effectiveness of postoperative intravenous ferric derisomaltose in spinal deformity surgery remains uncertain. Therefore, we designed this prospective randomized trial to evaluate whether intravenous ferric derisomaltose may improve anemia and prognosis in patients undergoing spinal deformity surgery compared with oral iron.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Ferric derisomaltoseIron to be administered as intravenous ferric derisomaltose: Where Hb (hemoglobin) ≥100 g/L, dosage according to body weight is as follows: Body weight <50 kg: 500mg; Body weight 50 to <70 kg: 1000 mg; Body weight ≥70 kg: 1500 mg. Where Hb <100 g/L, dosage according to body weight is as follows: Body weight <50 kg: 500mg; Body weight 50 to <70 kg: 1500mg; Body weight ≥70 kg: 2000 mg. The maximial dose should not exceed 20mg/kg body weight, rounded off to the nearest 100mg |
| Control group | Active comparator | Drug: Ferrous succinateIron to be administered as oral ferrous succinate: 1 tablet (100 mg) tid (three times daily), starting on the first postoperative day and continuing for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferric derisomaltoseAlso: MONOFER®Single intravenous dose ferric derisomaltose | Drug | Treatment group |
| Ferrous succinateDaily oral dose of 100 mg iron (ferrous succinate) tid postoperatively | Drug | Control group |
Primary outcome
Change in hemoglobin concentration
Time frame: At 14 days
Change in hemoglobin concentrations from POD(postoperative day)1 to POD14
29 secondary outcomes
Change in hemoglobin concentration
Time frame: At 5 days
Change in hemoglobin concentration
Time frame: At 35 days
Correction of anemia
Time frame: At 5 days
Correction of anemia
Time frame: At 14 days
Correction of anemia
Time frame: At 35 days
Change in serum iron
Time frame: At 5 days
Change in serum iron
Time frame: At 14 days
Change in serum iron
Time frame: At 35 days
Change in ferritin
Time frame: At 5 days
Change in ferritin
Time frame: At 14 days
Change in ferritin
Time frame: At 35 days
Change in transferrin saturation
Time frame: At 5 days
Change in transferrin saturation
Time frame: At 14 days
Change in transferrin saturation
Time frame: At 35 days
Change in soluble transferrin receptor
Time frame: At 5 days
Change in soluble transferrin receptor
Time frame: At 14 days
Change in soluble transferrin receptor
Time frame: At 35 days
EQ-5D
Time frame: At 5 days
EQ-5D
Time frame: At 14 days
EQ-5D
Time frame: At 35 days
Fatigue score
Time frame: At 5 days
Fatigue score
Time frame: At 14 days
Fatigue score
Time frame: At 35 days
Barthel Index
Time frame: At 5 days
Barthel Index
Time frame: At 14 days
Barthel Index
Time frame: At 35 days
Length of hospital stay
Time frame: At 3 months
Adverse events
Time frame: At 3 months
Infection
Time frame: At 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Background: PubMed 38267243Zhan J, Jiao Y, Chen W, Huang Y, Shen J. Effects of ferric derisomaltose on postoperative anaemia in adult spinal deformity surgery: a study protocol for a randomised controlled trial. BMJ Open. 2024 Jan 24;14(1):e080952. doi: 10.1136/bmjopen-2023-080952.
- Individual participant dataSharing planned: Yes. Coded data is anticipated to be shared with potential collaborators.
Related trials for Perioperative Anemia
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingObservational study
POASAC Study (Preoperative Anemia Severity and Classification Study)
Anemia
RecruitingPhase 4
Tranexamic Acid for Bleeding Reduction During TURP Surgery
Benign Prostatic Hyperplasia, Transurethral Resection of the Prostate
Recruiting
Kids With Iron Deficiency and Scoliosis
Adolescent Idiopathic Scoliosis, Neuromuscular Scoliosis
Recruiting
The Effect of Combined Iron Protocols on Perioperative Allogeneic Transfusion
Anemia, Iron Deficiency Anemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Weiyun Chen, MD principal investigator
Peking Union Medical College Hospital
Jianxiong Shen, MD study director
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferric derisomaltose and Ferrous succinate in people with Perioperative Anemia and Surgery, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianxiong Shen, MD (01069152701, sjxpumch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hemoglobin concentration (time frame: At 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05714007, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.