Anemia, Hip Fracture
Conditions
Brief 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.
Detailed description
The results of this study may dramatically alter the manner in which surgeons manage hip fracture patients in Canada. The use of topical TXA in operatively-treated hip fracture patients has the potential to reduce perioperative blood loss and consequently reduce exposure to allogeneic blood transfusion. This will positively influence post-operative morbidity and mortality, while at the same time substantially reduce hospital length of stay and overall health care costs. The proposed study is felt to have minimal risk, and is a relatively inexpensive study. Update: An interim analysis was completed in January 2018. The Data Safety Monitoring Committee reviewed the results and recommend the trial continue as planned. The final data analysis is in process. The abstract will be uploaded upon completion.
Interventions
DRUGTranexamic Acid
OTHERSaline Wash
Sponsors
Sault Area Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in hemoglobin | 1 day and 3 days post-surgery | change in hemoglobin levels day 1 and 3 post-op compared to pre-op values and need for allogenic blood transfusion up to 3 days post-op |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | 30 days post-surgery | — |
| Reduced risk of thrombotic event | 30 days post-surgery | Measure incidence of venous thromboembolism (symptomatic ultrasound proven deep vein thrombosis or pulmonary embolism diagnosed by a ventilation-perfusion scan or computed tomography angiogram) |
| Reduced peri-operative complications | 30 days post-surgery | (post-operative surgical site infection, acute coronary syndrome, cerebrovascular event) |
Countries
Canada
Outcome results
None listed