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

NCT06080893 | Completed Phase 4

• 1 other identifier: Istanbul Faculty of Medicine
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Fractures; Anemia; Complication,Postoperative

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Mortality

  6th and 12th month mortality information

  6th and 12th months

Study Arms (2)

Ferric Carboxymaltose - Administrated Group

EXPERIMENTAL

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

Ferric Carboxymaltose - Not Administrated Group

NO INTERVENTION

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

Interventions

Ferric carboxymaltose 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

Also known as: Ferinject

Ferric Carboxymaltose - Administrated Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \>65 years

You may not qualify if:

• \< 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.)

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

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

Istanbul, Çapa / Fatih, 34093, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 34079413 RESULT

• 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.

  PMID: 34006287 RESULT

• 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.

  PMID: 20124051 RESULT

• 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.

  PMID: 27195774 RESULT

• 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.

  PMID: 22353604 RESULT

• 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.

  PMID: 27624208 RESULT

MeSH Terms

Conditions

Hip Fractures; Anemia; Postoperative Complications

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mert Ballı

  Istanbul Faculty of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant İnvestigator

Study Record Dates

• First Submitted: October 8, 2023
• First Posted: October 12, 2023
• Study Start: October 10, 2023
• Primary Completion: June 10, 2024
• Study Completion: March 24, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

TU (1)