This is a Study to Verify if Tranexamic Acid Can Reduce the Anemia After a Femoral Shaft Fracture… (NCT04803591) | Clinical Trial Compass
WithdrawnPhase 4
This is a Study to Verify if Tranexamic Acid Can Reduce the Anemia After a Femoral Shaft Fractures Surgery
Stopped: Not approved by Ethics Commettee
0Started 2021-08-01
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 dur…