Status:
WITHDRAWN
This is a Study to Verify if Tranexamic Acid Can Reduce the Anemia After a Femoral Shaft Fractures Surgery
Lead Sponsor:
Christian Candrian
Conditions:
Femoral Shaft Fracture
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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, blo...
Detailed Description
Lower limb procedures represent the majority of orthopaedic surgeries, including joint arthroplasties, sport medicine treatments, and fractures osteo-synthesis, with a rate over 500 per 100,000 popula...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04803591
Start Date
August 1 2021
End Date
September 1 2026
Last Update
October 13 2021
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.