Does Early Administration of Tranexamic Acid Reduce Blood Loss and Perioperative Transfusion Requirement
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|ClinicalTrials.gov Identifier: NCT03182751|
Recruitment Status : Recruiting
First Posted : June 9, 2017
Last Update Posted : October 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hip Fractures||Drug: Tranexamic Acid (TXA) Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||156 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Subjects will be randomized into one of two study groups: TXA administration (treatment) or placebo (control). In order to ensure balance on the subject demographics between the two study groups, the subjects will be stratified on gender, age group (<75 vs. ≥75) and body mass index (<30 vs. ≥30). Within each stratum, subjects will be assigned to either the treatment group or control group using an electronic dynamic allocation program housed in a computer application developed by personnel in the Division of Biomedical Statistics and Informatics.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Using dynamic allocation will ensure that the study subjects will remain balanced on the stratification factors and the treatment group assignment throughout the entire subject accrual phase. This system will be utilized by Central pharmacy personnel to generate the treatment group assignments. Medications will then be delivered from the Central Pharmacy to the emergency department in packaging that does not delineate whether it contains placebo or tranexamic acid. Thus, the patient, treating surgeon, emergency department physician, residents, hospitalist group, anesthesiologist, and data collectors will remain blinded to the treatment assignment.|
|Official Title:||Does Early Administration of Tranexamic Acid Reduce Blood Loss and Perioperative Transfusion Requirement in Low Energy Hip Fracture Patients?|
|Actual Study Start Date :||April 2, 2018|
|Estimated Primary Completion Date :||October 1, 2021|
|Estimated Study Completion Date :||October 1, 2021|
Active Comparator: Tranexamic Acid Arm (TXA)
TXA will be administered intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours.
Drug: Tranexamic Acid (TXA)
The cohort of patients treated with early administration of TXA in the Emergency Department will be compared to a control group who were not treated with TXA at any point.
Other Name: Cyklokapron
Placebo Comparator: Control Arm
Patients in the control group will receive a placebo medication in the Emergency Department. Neither group will receive perioperative bolus dosing of TXA.
The cohort of patients treated with a placebo in the Emergency Department will be compared to the active comparator group that will receive early administration of Tranexamic Acid.
- Proportion of patients transfused at least 1 unit of packed red blood cells [ Time Frame: Length of hospitalization; average stay is 3 to 5 days. ]Transfusion will be considered for all patients with hemoglobin values of less than 8 g/dL with persistent symptoms or history of significant cardiac disease that may render the patient less able to compensate for significant anemia. Blood transfusion will be considered in all patients with hemoglobin less than 7 g/dL, regardless of symptoms.
- Mean number of units transfused per patient [ Time Frame: Length of hospitalization; average stay is 3 to 5 days. ]Number of units of packed red blood cells per patient
- Calculated blood loss [ Time Frame: Length of hospitalization; average stay is 3 to 5 days ]Calculated blood loss per patient
- Incidence of symptomatic Venous Thromboembolism (VTE) [ Time Frame: Within 6 months of surgery ]Patients diagnosed with Venous Thromboembolism
- Wound complications [ Time Frame: Within 6 months of surgery ]Any patient diagnosed with a wound complication
- (Myocardial Infarction) MI diagnosed [ Time Frame: Within 6 months of surgery ]Any patient diagnosed with a myocardial infarction
- Cerebrovascular accident (CVA) diagnosed [ Time Frame: Within 6 months of surgery ]Any patient diagnosed with a cerebrovascular accident
- All-cause mortality [ Time Frame: At 6 months after surgery ]Any patient who suffers mortality
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): NCT03182751
|Contact: Chelsea Boe, MD||(507) firstname.lastname@example.org|
|Contact: Elsa C Chase, MBAemail@example.com|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Chelsea Boe, MD 507-284-1175 firstname.lastname@example.org|
|Principal Investigator: Brandon Yuan, MD|
|Principal Investigator:||Brandon Yuan, MD||Mayo Clinic|