Iron Supplementation for Geriatric Hip Fractures

• Sponsor: He Qifei (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05489952
• Collaborator: (none)
• Enrollment: 444
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 12.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hip Fractures; Fragility Fracture; Osteoporotic Fractures	Drug: iron sucrose and ferrous lactate	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 444 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Perioperative Iron Supplementation for Postoperative Rehabilitation of Geriatric Hip Fractures: a Multicenter, Randomized, Controlled Trial.
• Anticipated Study Start Date: Aug 15, 2022
• Anticipated Primary Completion Date: Feb 15, 2025
• Anticipated Study Completion Date: Aug 15, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: iron supplement group	Drug: 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.; Other Names: iron supplementation
No Intervention: control group

Outcome Measures

Primary Outcome Measures

1. 6-minute walk distance [6 months]

   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

1. Harris hip score [6 months]

   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.

2. perioperative blood transfusion rate [1 week]

   The proportion of the transfusions number to the total number of patients

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shenzhen Second People's Hospita	Shenzhen	Guangdong	China	518035

Sponsors and Collaborators

• He Qifei

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: He Qifei, Principal Investigator, Shenzhen Second People's Hospital
• ClinicalTrials.gov Identifier: NCT05489952
• Other Study ID Numbers: 20223357010
• First Posted: Aug 5, 2022
• Last Update Posted: Aug 5, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Additional relevant MeSH terms: Fractures, Bone; Hip Fractures; Osteoporotic Fractures; Iron; Ferric Oxide, Saccharated

Study Results

No Results Posted as of Aug 5, 2022