Iron Supplementation for Geriatric Hip Fractures
Primary Purpose
Hip Fractures, Fragility Fracture, Osteoporotic Fractures
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
iron sucrose and ferrous lactate
Sponsored by
About this trial
This is an interventional treatment trial for Hip Fractures
Eligibility Criteria
Inclusion Criteria:
- >65 years old patients with hip fracture
Patients with iron deficiency or anemia,
- preoperative hemoglobin <13g/ dL in males and <12g/ dL in females, and >9g/ dL,
- serum ferritin < 100 ng/ mL or serum ferritin 100-299 ng/ mL or transferrin saturation (TSAT) <20%
Exclusion Criteria:
- Coronary artery bypass grafting, percutaneous transluminal coronary angioplasty, and cardiac device implantation (including cardiac resynchronization) within preoperative 30 days
- Acute coronary syndrome, transient ischemic attack or stroke occurred within 30 days before surgery;
- Refused to sign the consent form to be included in the clinical trial group;
- Can't walk before injury;
- Use erythropoietic preparation within 3 months before surgery and oral iron preparation within 4 weeks 30 days before surgery(> 100 mg/ day)
- Patients with liver and kidney dysfunction
- Other conditions that the researchers considered inappropriate for inclusion
Sites / Locations
- Shenzhen Second People's HospitaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
iron supplement group
control group
Arm Description
Outcomes
Primary Outcome Measures
6-minute walk distance
The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise. The 6 MWT provides information regarding functional capacity, response to therapy and prognosis across a broad range of chronic cardiopulmonary conditions.
Secondary Outcome Measures
Harris hip score
The Harris Hip Scale (HHS) was developed for the assessment of the results of hip surgery, and is intended to evaluate various hip disabilities and methods of treatment in an adult population.
perioperative blood transfusion rate
The proportion of the transfusions number to the total number of patients
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05489952
Brief Title
Iron Supplementation for Geriatric Hip Fractures
Official Title
Efficacy and Safety of Perioperative Iron Supplementation for Postoperative Rehabilitation of Geriatric Hip Fractures: a Multicenter, Randomized, Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2022 (Anticipated)
Primary Completion Date
February 15, 2025 (Anticipated)
Study Completion Date
August 15, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
He Qifei
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Geriatric hip fracture is an important disease that affects the health life of the elderly in China. Geriatric hip fracture is often complicated by a variety of comorbidities due to advanced age. And anemia is a common comorbidity. At present perioperative management of geriatric hip fracture, transfusion is only indicated for moderate and severe anemia, while no special medical intervention for mild anemia in China. More and more studies have found that iron can not only correct anemia, but also improve cardiac function, patients' quality of life and function. This study investigated the effect of perioperative iron supplementation on activity tolerance in elderly patients with hip fracture complicated with iron deficiency anemia. The study was a randomized, parallel controlled clinical study. Due to the requirements of the ethics committee, the unblinded setting was cancelled due to ethical considerations. Research will be grouped according to whether to accept iron supplementation treatment, are divided into 2 groups, respectively, iron treatment group and the traditional method. The method of randomization was stratified block randomization. The experimental group added to the intravenous iron sucrose during perioperative period according to the degree of iron deficiency. If there is still a iron deficiency or anemia at discharge, oral ferrous lactate is added after discharge. The outcomes include 6-minute walk distance, Harris score, EQ-5D score six months after surgery, perioperative blood transfusion rate, and so on in the two groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Fragility Fracture, Osteoporotic Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
444 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
iron supplement group
Arm Type
Experimental
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
iron sucrose and ferrous lactate
Other Intervention Name(s)
iron supplementation
Intervention Description
The experimental group added to the intravenous iron sucrose during perioperative period according to the degree of iron deficiency. If there is still a iron deficiency or anemia at discharge, oral ferrous lactate is added after discharge.
Primary Outcome Measure Information:
Title
6-minute walk distance
Description
The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise. The 6 MWT provides information regarding functional capacity, response to therapy and prognosis across a broad range of chronic cardiopulmonary conditions.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Harris hip score
Description
The Harris Hip Scale (HHS) was developed for the assessment of the results of hip surgery, and is intended to evaluate various hip disabilities and methods of treatment in an adult population.
Time Frame
6 months
Title
perioperative blood transfusion rate
Description
The proportion of the transfusions number to the total number of patients
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
>65 years old patients with hip fracture
Patients with iron deficiency or anemia,
preoperative hemoglobin <13g/ dL in males and <12g/ dL in females, and >9g/ dL,
serum ferritin < 100 ng/ mL or serum ferritin 100-299 ng/ mL or transferrin saturation (TSAT) <20%
Exclusion Criteria:
Coronary artery bypass grafting, percutaneous transluminal coronary angioplasty, and cardiac device implantation (including cardiac resynchronization) within preoperative 30 days
Acute coronary syndrome, transient ischemic attack or stroke occurred within 30 days before surgery;
Refused to sign the consent form to be included in the clinical trial group;
Can't walk before injury;
Use erythropoietic preparation within 3 months before surgery and oral iron preparation within 4 weeks 30 days before surgery(> 100 mg/ day)
Patients with liver and kidney dysfunction
Other conditions that the researchers considered inappropriate for inclusion
Facility Information:
Facility Name
Shenzhen Second People's Hospita
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518035
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chiephy He, Dr
Phone
8615201278036
Email
dr_chiephy@hsc.pku.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Iron Supplementation for Geriatric Hip Fractures
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