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The Effect of Preoperative Ferric Carboxymaltose Administration on Mortality in Geriatric Hip Fractures

The Effect of Preoperative Ferric Carboxymaltose Administration on Mortality in Geriatric Hip Fractures

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06080893
Enrollment
209
Registered
2023-10-12
Start date
2023-10-10
Completion date
2025-03-24
Last updated
2025-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Complication,Postoperative, Hip Fractures

Keywords

administration, intravenous, aged, anemia / complications, anemia / drug therapy, ferric compounds, hip fractures / mortality, hip fractures / surgery

Brief summary

Hip fractures (HF) are the most common and serious pathology affecting the hip and are associated with a high mortality risk in elderly patients. The prevalence of HF is increasing day by day and surgery is often required for its treatment. Perioperative anemia not only hinders the early recovery and rapid rehabilitation of elderly patients, but also adversely increases the need for blood transfusion, prolongs hospital length of stay (HLS) and even increases the risk of death. Although the blood transfusion threshold is restrictive, approximately one or two thirds of elderly patients with hip fracture surgery (HFS) require blood transfusion during hospitalization, and blood transfusion also has potential side effects.The most important factor in the development of anemia in HF is blood loss; however, there are other mechanisms (renal failure, inflammation, iatrogenic hemodilution) that lead to the selection of different therapeutic approaches.Oral or intravenous iron supplementation is a well-accepted alternative to counteract or prevent perioperative anemia, stimulate erythropoiesis and increase Hgb level in elderly patients. However, there are few studies addressing the relationship between iron therapy and clinical outcomes or mortality. Because ferric carboxymaltose (FCM) allows doses of 2 g in a single session (and can be administered by a short IV infusion of 15-20 minutes), and furthermore, FCM is excellently tolerated and safe for patients. This study was planned to investigate the relationship between FCM supplementation and blood transfusion volume, HLS, postoperative infection and mortality.

Detailed description

In the prospective randomized controlled study, a 6 - 12 month follow-up of participants undergoing hip fracture surgery with and without preoperative FCM treatment will be performed. Planning is being made with a total of 200 participants from 100 participants each in the experimental and control groups. Participants over the age of 65 who are diagnosed with hip fracture at Istanbul University Istanbul Faculty of Medicine Orthopedics and Traumatology Clinic will be included in the study. Participants who meet the inclusion criteria will be randomized into 2 groups as participants with and without preopaerative FCM (20 min iv infusion) so as to evaluate laboratory values during hospital stay, perop and postop ES transfusion needs, post-discharge 6th week Hgb value and 6th and 12th month mortality information. The parameters to be examined in clinical controls in the study are age, gender, smoking, comorbidities if any, hip fracture type, surgical treatment, ASA score, body mass index, preop/postop/pre-discharge/6th week Hgb value, perop/postop transfusion amount, preop INR value and 6th month/12th month mortality status.

Interventions

DRUGFerric carboxymaltose

FCM can be administered in a short IV infusion of 15-20 minutes, allowing doses of 2 g in a single session, and furthermore, FCM is excellently tolerated and safe for patients. FCM will be administered intravenously at preop 24th hour according to weight and preop hgb level

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* \>65 years

Exclusion criteria

* \< 65 years * Tumor-induced pathological fractures * Patients undergoing preop ES replacement * Ferric Carboxymaltose drug allergy * Multiple trauma * Receiving iron therapy in any form at the time of application * Those who cannot come to postop clinical follow-up (out of town, etc.)

Design outcomes

Primary

MeasureTime frameDescription
Mortality6th and 12th months6th and 12th month mortality information

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026