Tranexamic Acid After Pathological Fracture Treated With Modular Arthroplasty

Tranexamic Acid After Pathological Fracture Treated With Modular Arthroplasty: Retrospective Observational Study

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

Study Overview

• Status: Completed
• Conditions: Metastases to Bone
• Intervention / Treatment: Drug: Tranexamic acid injection

Detailed Description

Tranexamic acid is an efficacious medication for curtailing blood loss, haemoglobin drop, and the requirement for transfusions. Additionally, it is a secure medication, even when administered to oncology patients receiving reduction haemarthroplasty for pathological femoral fractures.

• Study Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• Poland
  • Podkarpackie
    • Brzozów, Podkarpackie, Poland, 36-200
      • SzSPOO Brzozów

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• Patological fracture
• Arthroplasty using a modular prosthesis.

Exclusion Criteria:

• threatened fracture
• intraoperative blood transfusion
• fracture fixation

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Tranexamic acid were administered at a dose of 1.0 g during the induction of anaesthesia and immediately after surgery.
Non-TXA; Tranexamic acid were not administred to the participants .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who require a blood transfusion.	Need of blood transfusion	During Hospitalization (up to day 10)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimeted blood lost after surgery.	Gross total blood loss was estimated utilizing the formula PBV × (Hctpre- Hctpost)/Hcta	During Hospitalization (up to day 3)
Number of participants with embolic complication.	Yes or No	During Hospitalization (up to day 10)

Collaborators and Investigators

• Sponsor: Piotr Biega

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: January 12, 2024
• First Submitted That Met QC Criteria: February 2, 2024
• First Posted (Estimated): February 6, 2024

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Blood Transfusion; Bone; Neoplasm Metastasis
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Fractures, Bone; Wounds and Injuries; Neoplastic Processes; Neoplasm Metastasis; Fractures, Spontaneous; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 01 (Miami VAHS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The datasets used and/or analysed during the current study are available from the corresponding investigator on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No