This is a Study to Verify if Tranexamic Acid Can Reduce the Anemia After a Femoral Shaft Fractures Surgery

• Status: Withdrawn
• Trial end date: 2026-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators are going to evaluate if adding Tranexamic Acid in femoral shaft fractures surgery can lead to any advantages to the participants, namely if it can reduce post-operative anaemia, blood loss, blood transfusion requirements, length and cost of hospitalisation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Christian Candrian
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

• Acute femoral shaft fracture.

• Patients treated surgically with intramedullary nail or femoral plate

• Patients aged 18-80 years old.

• Patients with a BMI >18.5 and <35.

• Patients able to provide informed consent and follow all the study procedures as indicated by the protocol.

• Informed Consent as documented by signature

Exclusion Criteria:

• Pathological fracture or other lower limb fractures associated or multiple fractures.

• Use of any anticoagulant at the time of admission (eg, vitamin K antagonists, anti-thrombin agents, antiplatelet agents or factor IIa and Xa inhibitors).

• Contraindications to TXA (eg documented allergy to TXA).

• Hepatic dysfunction (aspartate transaminase (AST)/alanine transaminase (ALT)>60 U/l) or renal dysfunction (Cr >1.5 mg/dl of glomerular filtration rate (GFR)>30 ml/min).

• History of DVT or pulmonary embolus.

• Active coronary artery disease or cerebrovascular accident (event in the past 12 months).

• Coagulopathy based on admission laboratory values (international normalised ratio (INR)>1.4, partial thromboplastin time (PTT)>1.4× normal sec, platelets <50 000 per mm3)

• Women who are pregnant or breast feeding.

• Known or suspected non-compliance, drug or alcohol abuse.

• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.

• Participation in another study with investigational drug within the 30 days preceding and during the present study.

• Previous enrolment into the current study.

• Enrolment of the investigator, his/her family members, employees and other dependent persons.