Tranexamic Acid After Pathological Fracture Treated With Modular Arthroplasty

NCT06244498 | Completed FDA Drug

• 1 other identifier: 01
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This study assesses the safety and efficacy of TXA for patients treated for pathological femur fractures using modular prosthetics.

Conditions

Metastases to Bone

Keywords

Blood Transfusion; Neoplasm Metastasis; Bone

Outcome Measures

Primary Outcomes (1)

• Number of participants who require a blood transfusion.

  Need of blood transfusion

  During Hospitalization (up to day 10)

Secondary Outcomes (2)

• Estimeted blood lost after surgery.

  During Hospitalization (up to day 3)

• Number of participants with embolic complication.

  During Hospitalization (up to day 10)

Study Arms (2)

TXA

Tranexamic acid was administered to the participants at a dose of 1.0 g during the induction of anaesthesia and immediately after the operation.

Drug: Tranexamic acid injection

Non-TXA

Tranexamic acid were not administred to the participants .

Interventions

Tranexamic acid injection DRUG

Tranexamic acid were administered at a dose of 1.0 g during the induction of anaesthesia and immediately after surgery.

TXA

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Investigetor analysed a group of paticipants who underwent surgery for metastatic tumours of the proximal femur using modular prostheses between 2017 and 2021.

You may qualify if:

• Patological fracture
• Arthroplasty using a modular prosthesis.

You may not qualify if:

• threatened fracture
• intraoperative blood transfusion
• fracture fixation

Sponsors & Collaborators

• Piotr Biega: lead

Study Sites (1)

SzSPOO Brzozów

Brzozów, Podkarpackie Voivodeship, 36-200, Poland

Location

Related Publications (2)

• CRASH-2 collaborators; Roberts I, Shakur H, Afolabi A, Brohi K, Coats T, Dewan Y, Gando S, Guyatt G, Hunt BJ, Morales C, Perel P, Prieto-Merino D, Woolley T. The importance of early treatment with tranexamic acid in bleeding trauma patients: an exploratory analysis of the CRASH-2 randomised controlled trial. Lancet. 2011 Mar 26;377(9771):1096-101, 1101.e1-2. doi: 10.1016/S0140-6736(11)60278-X.

  PMID: 21439633 RESULT

• Biega P, Guzik G. Tranexamic Acid Reduces Transfusion Rates After Modular Hemiarthroplasty for Pathological Femoral Fractures: A Retrospective Study. Adv Orthop. 2025 Oct 30;2025:3173784. doi: 10.1155/aort/3173784. eCollection 2025.

  PMID: 41180854 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Rzeszow University of Technology - Assistant Professor

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: February 6, 2024
• Study Start: January 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: February 6, 2024

Record last verified: 2024-02

Locations

PL (1)