Topical Tranexamic Acid (TXA) in Hip Fractures

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Mechanisms by which to reduce exposure to allogeneic blood are of financial and clinical benefit in the hip fracture population. Tranexamic acid (TXA) is an inexpensive medication with low complication risk. Its use in the hip fracture population is unproven. The purpose of this study is to evaluate the efficacy and safety of topical tranexamic acid in reduction of peri-operative blood loss in hip fracture surgery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sault Area Hospital
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

All of the following criteria must be met to be eligible:

1. 18 years of age or older

2. Diagnosis of hip fracture (Intracapsular, Intratrochanteric or Subtrochanteric) requiring surgical repair

3. Patient/surrogate decision maker provide signed informed consent

Exclusion Criteria:

Participants cannot be included in this study if any of the following criteria apply:

1. Patient has documented renal failure with glomerular filtration rate of <30ml/min/1.73m2

2. Documented allergy to tranexamic acid

3. Current use of hormone replacement therapy

4. Acquired disturbances of colour vision

5. Refusal of blood products

6. Pre-operative use of anticoagulant therapy (Coumadin, heparin < 5 days of surgery, fibrinolytic disorders requiring intraoperative anti-fibrinolytic treatment)

7. Coagulopathy (pre-operative platelet count <150,000/mm3, International Normalized Ratio (INR) >1.4, prolonged Partial Thromboplastin Time (PTT) >1.4x normal)

8. Hematuria

9. Acute coronary syndrome within 6 weeks of fracture

10. Any history of venous thromboembolism

11. Any intraoperative surgical/medical/anesthetic complications i.e.: myocardial infarction or neurovascular injury occurring prior to application of the tranexamic acid

12. Pregnant or lactating

13. Any major medical or psychiatric disorder that in the opinion of the investigator, might prevent the subject from completely participating in the study or interfere with the interpretation of the study results

14. Unable/unwilling to provide informed consent