Topical Tranexamic Acid (TXA) in Hip Fractures, A Double-Blind, Randomized Controlled Trial
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Sault Area Hospital
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- Change in hemoglobin
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All of the following criteria must be met to be eligible:
- •18 years of age or older
- •Diagnosis of hip fracture (Intracapsular, Intratrochanteric or Subtrochanteric) requiring surgical repair
- •Patient/surrogate decision maker provide signed informed consent
Exclusion Criteria
- •Participants cannot be included in this study if any of the following criteria apply:
- •Patient has documented renal failure with glomerular filtration rate of \<30ml/min/1.73m2
- •Documented allergy to tranexamic acid
- •Current use of hormone replacement therapy
- •Acquired disturbances of colour vision
- •Refusal of blood products
- •Pre-operative use of anticoagulant therapy (Coumadin, heparin \< 5 days of surgery, fibrinolytic disorders requiring intraoperative anti-fibrinolytic treatment)
- •Coagulopathy (pre-operative platelet count \<150,000/mm3, International Normalized Ratio (INR) \>1.4, prolonged Partial Thromboplastin Time (PTT) \>1.4x normal)
- •Acute coronary syndrome within 6 weeks of fracture
- •Any history of venous thromboembolism
Arms & Interventions
Tranexamic Acid Wash
Participants in the experimental arm will receive a wash of tranexamic acid topically at the site of surgery.
Intervention: Tranexamic Acid (Drug)
Saline Wash
Participants in the control arm will receive a wash of saline topically at the site of surgery.
Intervention: Saline Wash (Other)
Outcomes
Primary Outcomes
Change in hemoglobin
Time Frame: 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 Outcomes
- All-cause mortality(30 days post-surgery)
- Reduced risk of thrombotic event(30 days post-surgery)
- Reduced peri-operative complications(30 days post-surgery)