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

Sponsor

Istanbul University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06080893

Collaborator

(none)

200

Enrollment

Location

18.1

Anticipated Duration (Months)

11.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hip Fractures Anemia Complication,Postoperative	Drug: Ferric carboxymaltose

Detailed Description

In the prospective randomized controlled study, a 6 - 12 month follow-up of patients undergoing hip fracture surgery with and without preoperative FCM treatment will be performed. Planning is being made with a total of 200 patients from 100 patients each in the experimental and control groups. Patients 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. Patients who meet the inclusion criteria will be randomized into 2 groups as patients 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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Ferric Carboxymaltose - Administrated Group Patients eligible for inclusion who received preop FCM intravenous therapy FCM will be administered intravenously at preop 24th hour according to weight and preop hgb level	Drug: 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 Other Names: Ferinject
Ferric Carboxymaltose - Not Administrated Group Patients eligible for inclusion who are not received preop FCM intravenous therapy

Arm

Intervention/Treatment

Ferric Carboxymaltose - Administrated Group

Patients eligible for inclusion who received preop FCM intravenous therapy FCM will be administered intravenously at preop 24th hour according to weight and preop hgb level

Drug: 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

Other Names:

Ferinject

Ferric Carboxymaltose - Not Administrated Group

Patients eligible for inclusion who are not received preop FCM intravenous therapy