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

March 24, 2025 updated by: Mustafa Özkaya, Istanbul University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

209

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Çapa / Fatih
      • Istanbul, Çapa / Fatih, Turkey, 34093
        • Istanbul University, Istanbul Faculty of Medicine, Department Orthopaedics and Traumatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Study Population

Hip fracture patients over 65 years of age who meet the inclusion criteria will be randomized and comparison groups will be determined. Patients who will be administered ferric carboxymaltose iv will constitute our experimental group, while the non-administered group will constitute the comparison group.

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
No Intervention: Ferric Carboxymaltose - Not Administrated Group
Patients eligible for inclusion who are not received preop FCM intravenous therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 6th and 12th months
6th and 12th month mortality information
6th and 12th months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Study Chair: Mert Ballı, Istanbul Faculty of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2023

Primary Completion (Actual)

June 10, 2024

Study Completion (Actual)

March 24, 2025

Study Registration Dates

First Submitted

October 8, 2023

First Submitted That Met QC Criteria

October 8, 2023

First Posted (Actual)

October 12, 2023

Study Record Updates

Last Update Posted (Actual)

March 26, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Istanbul Faculty of Medicine

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anemia

Clinical Trials on Ferric carboxymaltose

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe