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

NCT ID: NCT06080893

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 209 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-10
• Study Completion Date: 2025-03-24

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.

Conditions

Hip Fractures; Anemia; Complication,Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Ferric carboxymaltose

Intervention Type: DRUG

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

Ferric Carboxymaltose - Not Administrated Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Ferinject

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.)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Mustafa Özkaya

Assistant İnvestigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mert Ballı

Role: STUDY_CHAIR

Istanbul Faculty of Medicine

Locations

Istanbul University, Istanbul Faculty of Medicine, Department Orthopaedics and Traumatology

Istanbul, Çapa / Fatih, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Jones JJ, Mundy LM, Blackman N, Shwarz M. Ferric Carboxymaltose for Anemic Perioperative Populations: A Systematic Literature Review of Randomized Controlled Trials. J Blood Med. 2021 May 26;12:337-359. doi: 10.2147/JBM.S295041. eCollection 2021.

Reference Type: RESULT

PMID: 34079413 (View on PubMed)

Clemmensen SZ, Kragholm KH, Melgaard D, Hansen LT, Riis J, Cavallius C, Morch MM, Krogager ML. Association between intravenous iron therapy and short-term mortality risk in older patients undergoing hip fracture surgery: an observational study. J Orthop Surg Res. 2021 May 18;16(1):320. doi: 10.1186/s13018-021-02462-x.

Reference Type: RESULT

PMID: 34006287 (View on PubMed)

Parker MJ. Iron supplementation for anemia after hip fracture surgery: a randomized trial of 300 patients. J Bone Joint Surg Am. 2010 Feb;92(2):265-9. doi: 10.2106/JBJS.I.00883.

Reference Type: RESULT

PMID: 20124051 (View on PubMed)

Bernabeu-Wittel M, Romero M, Ollero-Baturone M, Aparicio R, Murcia-Zaragoza J, Rincon-Gomez M, Monte-Secades R, Melero-Bascones M, Rosso CM, Ruiz-Cantero A; PAHFRAC-01 Investigators. Ferric carboxymaltose with or without erythropoietin in anemic patients with hip fracture: a randomized clinical trial. Transfusion. 2016 Sep;56(9):2199-211. doi: 10.1111/trf.13624. Epub 2016 May 14.

Reference Type: RESULT

PMID: 27195774 (View on PubMed)

Bernabeu-Wittel M, Aparicio R, Romero M, Murcia-Zaragoza J, Monte-Secades R, Rosso C, Montero A, Ruiz-Cantero A, Melero-Bascones M; PAHFRAC-01 investigators. Ferric carboxymaltose with or without erythropoietin for the prevention of red-cell transfusions in the perioperative period of osteoporotic hip fractures: a randomized contolled trial. The PAHFRAC-01 project. BMC Musculoskelet Disord. 2012 Feb 21;13:27. doi: 10.1186/1471-2474-13-27.

Reference Type: RESULT

PMID: 22353604 (View on PubMed)

Munoz M, Gomez-Ramirez S, Auerbach M. Stimulating erythropoiesis before hip fracture repair for reducing blood transfusion: should we change the hemoglobin cutoff level for defining anemia in females? Transfusion. 2016 Sep;56(9):2160-3. doi: 10.1111/trf.13750. No abstract available.

Reference Type: RESULT

PMID: 27624208 (View on PubMed)

Other Identifiers

Istanbul Faculty of Medicine

Identifier Type: -

Identifier Source: org_study_id