Evaluation of TXA Prior to Surgery in the Geriatric Hip Fracture Population (TAHFT)
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|ClinicalTrials.gov Identifier: NCT03923959|
Recruitment Status : Enrolling by invitation
First Posted : April 23, 2019
Last Update Posted : February 23, 2021
|Condition or disease||Intervention/treatment||Phase|
|Hip Fractures||Drug: Tranexamic Acid Injectable Solution Other: Placebo||Phase 3|
A significant portion of the geriatric hip fracture population have comorbidities including chronic kidney disease, congestive heart failure, ischemic heart disease, stroke, etc. These patients may be anemic prior to the surgery, and are at increased risk for further blood loss as a result of the fracture and surgical operation. However, intra-operative or post-operative blood transfusions also increase the risk of renal and cardiac complications in this population.
Tranexamic acid (TXA) is an anti-fibrinolytic medication that has transformed total joint replacement management regarding blood loss prevention. Geriatric patients requiring emergent hip fracture repair may significantly benefit from routine administration of TXA prior to the procedure to decrease the risk of blood loss. Thus, treatment may further reduce the percentage of patients who experience blood transfusions and complications associated with transfusions.
The investigators will examine if administration of TXA prior to incision in the geriatric hip fracture patient population decreases the risk of intra-operative or post-operative blood transfusions compared to placebo.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A prospective, double-blinded, randomized study in the geriatric hip fracture population comparing those who receive intravenous tranexamic acid prior to incision to those who receive a placebo.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||All OR pharmacists are un-blinded to subject randomization.|
|Official Title:||Evaluation of Tranexamic Acid Prior to Surgery in the Geriatric Hip Fracture Population for the Reduction of Post-Operative Blood Transfusion|
|Actual Study Start Date :||June 1, 2019|
|Estimated Primary Completion Date :||June 1, 2021|
|Estimated Study Completion Date :||June 1, 2022|
Active Comparator: Intervention
100 cc normal saline with 1g of tranexamic acid in solution
Drug: Tranexamic Acid Injectable Solution
100 cc normal saline mixed with 1g of tranexamic acid in solution
Other Name: Cyklokapron
Placebo Comparator: Placebo
100 cc normal saline
100 cc normal saline
- Blood Transfusions [ Time Frame: 3 Months ]To compare the percentage of patients that receive acute post-operative transfusions in the group administered intravenous tranexamic acid compared to the group administered placebo.
- Complication Rate [ Time Frame: 3 Months ]Determine if participants randomized to TXA experienced increased risk of complications compared to placebo. Complications include number of deep vein thrombosis events, pulmonary emboli events, myocardial infarction events, and cerebral vascular events within 12 weeks post hip fracture surgery.
- Hospital Readmission [ Time Frame: 30 Days ]Determine differences between the groups in 30 day readmission rates.
- Mortality Rate [ Time Frame: 90 Days ]Death within 90 days post hip surgery
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): NCT03923959
|United States, Pennsylvania|
|Lancaster General Heatlh / Penn Medicine|
|Lancaster, Pennsylvania, United States, 17602|
|Principal Investigator:||Gregory Tocks, DO||Penn Medicine / Lancaster General Hospital|