Clinical trial

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

Name
Istanbul Faculty of Medicine
Description
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.
Trial arms
Trial start
2023-10-10
Estimated PCD
2024-12-01
Trial end
2025-01-01
Status
Recruiting
Treatment
Ferric 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
Arms:
Ferric Carboxymaltose - Administrated Group
Other names:
Ferinject
Size
200
Primary endpoint
Mortality
6th and 12th months
Eligibility criteria
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.)
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '12 Months', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}
Updated at
2023-10-24

1 organization

1 product

3 indications

Indication
Hip Fractures
Indication
Anaemia