Sault Area Hospital
Sault Ste. Marie, Ontario, P6B0A8, Canada
NCT Number: NCT02993341
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.
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Notify Me18 year–100 year
All sexes
Interventional
Phase 3
Sault Ste. Marie, Ontario, P6B0A8, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All of the following criteria must be met to be eligible:
Exclusion criteria
Participants cannot be included in this study if any of the following criteria apply:
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
Time frame: 30 days post-surgery
Time frame: 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)
Time frame: 30 days post-surgery
(post-operative surgical site infection, acute coronary syndrome, cerebrovascular event)
Sault Area Hospital
Other
Topical Tranexamic Acid (TXA) in Hip Fractures, A Double-Blind, Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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