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

Primary Purpose

Perioperative Anemia, Surgery, Spinal Deformity

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Ferric derisomaltose
Ferrous succinate
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perioperative Anemia focused on measuring spinal deformity surgery, perioperative anemia, ferric derisomaltose, adult

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Age ≥18 years Received spinal deformity surgery 70 g/L ≤ Hb ≤ 110 g/L at POD1, or Hb ≤120 g/L at POD1 with a decrease in Hb of ≥20 g/L compared with baseline Informed consent was obtained voluntarily Exclusion Criteria 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.

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment group

Control group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Change in hemoglobin concentration
Change in hemoglobin concentrations from POD(postoperative day)1 to POD14

Secondary Outcome Measures

Change in hemoglobin concentration
Change in hemoglobin concentrations from POD1 to POD5
Change in hemoglobin concentration
Change in hemoglobin concentrations from POD1 to POD35
Correction of anemia
The percentage of effective correction of anemia (elevation of Hb >20g/L or Hb ≥120g/L) at POD5
Correction of anemia
The percentage of effective correction of anemia (elevation of Hb >20g/L or Hb ≥120g/L) at POD14
Correction of anemia
The percentage of effective correction of anemia (elevation of Hb >20g/L or Hb ≥120g/L) at POD35
Change in serum iron
Change in serum iron from POD1 to POD5
Change in serum iron
Change in serum iron from POD1 to POD14
Change in serum iron
Change in serum iron from POD1 to POD35
Change in ferritin
Change in ferritin from POD1 to POD5
Change in ferritin
Change in ferritin from POD1 to POD14
Change in ferritin
Change in ferritin from POD1 to POD35
Change in transferrin saturation
Change in transferrin saturation from POD1 to POD5
Change in transferrin saturation
Change in transferrin saturation from POD1 to POD14
Change in transferrin saturation
Change in transferrin saturation from POD1 to POD35
Change in soluble transferrin receptor
Change in soluble transferrin receptor from POD1 to POD5
Change in soluble transferrin receptor
Change in soluble transferrin receptor from POD1 to POD14
Change in soluble transferrin receptor
Change in soluble transferrin receptor from POD1 to POD35
EQ-5D
Quality of life measured by EQ-5D (European Quality of Life-5 Dimensions) at POD5
EQ-5D
Quality of life measured by EQ-5D at POD14
EQ-5D
Quality of life measured by EQ-5D at POD35
Fatigue score
Fatigue measured FACIT-F (The Functional Assessment of Chronic Illness Therapy-Fatigue) questionnaire at POD5
Fatigue score
Fatigue measured FACIT-F questionnaire at POD14
Fatigue score
Fatigue measured FACIT-F questionnaire at POD35
Barthel Index
Independence in daily activities measured by the Barthel questionnaire at POD 5
Barthel Index
Independence in daily activities measured by the Barthel questionnaire at POD 14
Barthel Index
Independence in daily activities measured by the Barthel questionnaire at POD 35
Length of hospital stay
Hospitalized days
Adverse events
Incidence of adverse events
Infection
Incidence of postoperative infection

Full Information

First Posted
January 26, 2023
Last Updated
September 28, 2023
Sponsor
Peking Union Medical College Hospital
Collaborators
Pharmacosmos A/S
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1. Study Identification

Unique Protocol Identification Number
NCT05714007
Brief Title
The Effects of Ferric Derisomaltose on Postoperative Anemia in Spinal Deformity Surgery
Official Title
The Effects of Ferric Derisomaltose on Postoperative Anemia in Patients Undergoing Spinal Deformity Surgery: A Prospective Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2023 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
Pharmacosmos A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perioperative Anemia, Surgery, Spinal Deformity, Adult
Keywords
spinal deformity surgery, perioperative anemia, ferric derisomaltose, adult

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ferric derisomaltose
Other Intervention Name(s)
MONOFER®
Intervention Description
Single intravenous dose ferric derisomaltose
Intervention Type
Drug
Intervention Name(s)
Ferrous succinate
Intervention Description
Daily oral dose of 100 mg iron (ferrous succinate) tid postoperatively
Primary Outcome Measure Information:
Title
Change in hemoglobin concentration
Description
Change in hemoglobin concentrations from POD(postoperative day)1 to POD14
Time Frame
At 14 days
Secondary Outcome Measure Information:
Title
Change in hemoglobin concentration
Description
Change in hemoglobin concentrations from POD1 to POD5
Time Frame
At 5 days
Title
Change in hemoglobin concentration
Description
Change in hemoglobin concentrations from POD1 to POD35
Time Frame
At 35 days
Title
Correction of anemia
Description
The percentage of effective correction of anemia (elevation of Hb >20g/L or Hb ≥120g/L) at POD5
Time Frame
At 5 days
Title
Correction of anemia
Description
The percentage of effective correction of anemia (elevation of Hb >20g/L or Hb ≥120g/L) at POD14
Time Frame
At 14 days
Title
Correction of anemia
Description
The percentage of effective correction of anemia (elevation of Hb >20g/L or Hb ≥120g/L) at POD35
Time Frame
At 35 days
Title
Change in serum iron
Description
Change in serum iron from POD1 to POD5
Time Frame
At 5 days
Title
Change in serum iron
Description
Change in serum iron from POD1 to POD14
Time Frame
At 14 days
Title
Change in serum iron
Description
Change in serum iron from POD1 to POD35
Time Frame
At 35 days
Title
Change in ferritin
Description
Change in ferritin from POD1 to POD5
Time Frame
At 5 days
Title
Change in ferritin
Description
Change in ferritin from POD1 to POD14
Time Frame
At 14 days
Title
Change in ferritin
Description
Change in ferritin from POD1 to POD35
Time Frame
At 35 days
Title
Change in transferrin saturation
Description
Change in transferrin saturation from POD1 to POD5
Time Frame
At 5 days
Title
Change in transferrin saturation
Description
Change in transferrin saturation from POD1 to POD14
Time Frame
At 14 days
Title
Change in transferrin saturation
Description
Change in transferrin saturation from POD1 to POD35
Time Frame
At 35 days
Title
Change in soluble transferrin receptor
Description
Change in soluble transferrin receptor from POD1 to POD5
Time Frame
At 5 days
Title
Change in soluble transferrin receptor
Description
Change in soluble transferrin receptor from POD1 to POD14
Time Frame
At 14 days
Title
Change in soluble transferrin receptor
Description
Change in soluble transferrin receptor from POD1 to POD35
Time Frame
At 35 days
Title
EQ-5D
Description
Quality of life measured by EQ-5D (European Quality of Life-5 Dimensions) at POD5
Time Frame
At 5 days
Title
EQ-5D
Description
Quality of life measured by EQ-5D at POD14
Time Frame
At 14 days
Title
EQ-5D
Description
Quality of life measured by EQ-5D at POD35
Time Frame
At 35 days
Title
Fatigue score
Description
Fatigue measured FACIT-F (The Functional Assessment of Chronic Illness Therapy-Fatigue) questionnaire at POD5
Time Frame
At 5 days
Title
Fatigue score
Description
Fatigue measured FACIT-F questionnaire at POD14
Time Frame
At 14 days
Title
Fatigue score
Description
Fatigue measured FACIT-F questionnaire at POD35
Time Frame
At 35 days
Title
Barthel Index
Description
Independence in daily activities measured by the Barthel questionnaire at POD 5
Time Frame
At 5 days
Title
Barthel Index
Description
Independence in daily activities measured by the Barthel questionnaire at POD 14
Time Frame
At 14 days
Title
Barthel Index
Description
Independence in daily activities measured by the Barthel questionnaire at POD 35
Time Frame
At 35 days
Title
Length of hospital stay
Description
Hospitalized days
Time Frame
At 3 months
Title
Adverse events
Description
Incidence of adverse events
Time Frame
At 3 months
Title
Infection
Description
Incidence of postoperative infection
Time Frame
At 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Age ≥18 years Received spinal deformity surgery 70 g/L ≤ Hb ≤ 110 g/L at POD1, or Hb ≤120 g/L at POD1 with a decrease in Hb of ≥20 g/L compared with baseline Informed consent was obtained voluntarily Exclusion Criteria 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianxiong Shen, MD
Phone
01069152701
Email
sjxpumch@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Weiyun Chen, MD
Phone
13691412863
Email
chenweiyun@pumch.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weiyun Chen, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jianxiong Shen, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianxiong Shen, MD
Email
sjxpumch@163.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Coded data is anticipated to be shared with potential collaborators.
IPD Sharing Time Frame
Anticipated that data from the study will become available within 5 years after publication of main data.
IPD Sharing Access Criteria
Data would only be shared with IRB approved collaborators.

Learn more about this trial

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

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