Iron supplementation for elderly patients with hip fractures
Efficacy and Safety of Perioperative Iron Supplementation for Postoperative Rehabilitation of Geriatric Hip Fractures: a Multicenter, Randomized, Controlled Trial.
This study tests whether giving iron supplements to elderly patients with hip fractures and low iron levels can help them recover better and feel more active after surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 444 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Shenzhen Second People's Hospital Academic / other |
| Locations | 1 site (Shenzhen, Guangdong) |
| Trial ID | NCT05489952 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of iron supplementation on activity tolerance in elderly patients suffering from hip fractures and iron deficiency anemia. It is a randomized, parallel controlled clinical trial that aims to determine whether perioperative iron treatment can improve outcomes for this vulnerable population. The study will compare patients receiving iron sucrose and ferrous lactate against those who do not receive supplementation. The focus is on enhancing recovery and quality of life for geriatric patients post-surgery.
Who should consider this trial
Good fit: Ideal candidates are patients over 65 years old with hip fractures and iron deficiency anemia.
Not a fit: Patients with recent cardiac interventions or severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve recovery and overall quality of life for elderly patients with hip fractures and anemia.
How similar studies have performed: Other studies have suggested that iron supplementation can improve outcomes in similar patient populations, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shenzhen, Guangdong
- Shenzhen Second People's Hospita — Shenzhen, Guangdong, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.