Clinical trial NCT05489952: 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
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hip Fractures
Fragility Fracture
Osteoporotic Fractures
Lead sponsor: Shenzhen Second People's Hospital
Sponsor class: OTHER
First posted: 2022-08-05
Enrollment: 444
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 6-minute walk distance
timeFrame: 6 months
Secondary outcomes:
measure: Harris hip score
timeFrame: 6 months
measure: perioperative blood transfusion rate
timeFrame: 1 week
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospita
state: Guangdong
Study officials:
References: