Tranexamic Acid After Pathological Fracture Treated With Modular Arthroplasty

Metastases to Bone Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06244498
• Other study ID #: 01
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2024
• Source: Podkarpackie Oncological Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patological fracture

• Arthroplasty using a modular prosthesis.

Exclusion Criteria:

• threatened fracture

• intraoperative blood transfusion

• fracture fixation

Related Conditions & MeSH terms

• Metastases to Bone
• Neoplasm Metastasis

Intervention

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

Locations

Country	Name	City	State
Poland	SzSPOO Brzozów	Brzozów	Podkarpackie

Sponsors (1)

Lead Sponsor	Collaborator
Piotr Biega

Country where clinical trial is conducted

Poland, 

References & Publications (1)

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 explorator — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who require a blood transfusion.	Need of blood transfusion	During Hospitalization (up to day 10)
Secondary	Estimeted blood lost after surgery.	Gross total blood loss was estimated utilizing the formula PBV × (Hctpre- Hctpost)/Hcta	During Hospitalization (up to day 3)
Secondary	Number of participants with embolic complication.	Yes or No	During Hospitalization (up to day 10)