Iron Supplementation for Geriatric Hip Fractures

NCT ID: NCT05489952

Last Updated: 2022-09-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 444 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-15
• Study Completion Date: 2025-08-15

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.

Conditions

Hip Fractures; Fragility Fracture; Osteoporotic Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

iron supplement group

Group Type: EXPERIMENTAL

iron sucrose and ferrous lactate

Intervention Type: DRUG

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.

control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

iron sucrose and ferrous lactate

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.

Intervention Type: DRUG

Other Intervention Names

iron supplementation

Eligibility Criteria

Inclusion Criteria

1. >65 years old patients with hip fracture

2. 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

1. Coronary artery bypass grafting, percutaneous transluminal coronary angioplasty, and cardiac device implantation (including cardiac resynchronization) within preoperative 30 days

2. Acute coronary syndrome, transient ischemic attack or stroke occurred within 30 days before surgery;

3. Refused to sign the consent form to be included in the clinical trial group;

4. Can't walk before injury;

5. Use erythropoietic preparation within 3 months before surgery and oral iron preparation within 4 weeks 30 days before surgery(> 100 mg/ day)

6. Patients with liver and kidney dysfunction

7. Other conditions that the researchers considered inappropriate for inclusion

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

He Qifei

OTHER

Sponsor Role: lead

Responsible Party

He Qifei

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Shenzhen Second People's Hospita

Shenzhen, Guangdong, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Chiephy He, Dr

Role: primary

dr_chiephy@hsc.pku.edu.cn

8615201278036

Other Identifiers

20223357010

Identifier Type: -

Identifier Source: org_study_id