Topical Tranexamic Acid (TXA) in Hip Fractures
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02993341|
Recruitment Status : Recruiting
First Posted : December 15, 2016
Last Update Posted : July 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hip Fracture Anemia||Drug: Tranexamic Acid Other: Saline Wash||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Topical Tranexamic Acid (TXA) in Hip Fractures, A Double-Blind, Randomized Controlled Trial|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2020|
Experimental: Tranexamic Acid Wash
Participants in the experimental arm will receive a wash of tranexamic acid topically at the site of surgery.
Drug: Tranexamic Acid
Placebo Comparator: Saline Wash
Participants in the control arm will receive a wash of saline topically at the site of surgery.
Other: Saline Wash
- 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
- All-cause mortality [ Time Frame: 30 days post-surgery ]
- Reduced risk of thrombotic event [ 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)
- Reduced peri-operative complications [ Time Frame: 30 days post-surgery ](post-operative surgical site infection, acute coronary syndrome, cerebrovascular event)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02993341
|Contact: Darren Costain, MD, MSc, FRCSC||(705)email@example.com|
|Sault Area Hospital||Recruiting|
|Sault Ste. Marie, Ontario, Canada, P6B0A8|
|Contact: Darren Costain, MD, MSc, FRCSC 705-942-5789 firstname.lastname@example.org|