The overall design of the study is 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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
283
100 cc normal saline mixed with 1g of tranexamic acid in solution
100 cc normal saline
Lancaster General Heatlh / Penn Medicine
Lancaster, Pennsylvania, United States
Count of Participants With Acute Post-operative Transfusion of Packed Red Blood Cells.
Count of participants with acute post-operative transfusion of packed red blood cells along with the corresponding 95% CI.
Time frame: 3 Months
Complication Rate
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.
Time frame: 3 Months
Hospital Readmission
Determine differences between the groups in 30 day readmission rates.
Time frame: 30 Days
Mortality Rate
Death within 90 days post hip surgery
Time frame: 90 Days
Length of Stay
Length of stay immediately post study intervention/surgery for hip fracture
Time frame: From date of study intervention/surgery for hip fracture until the date of discharge or date of death from any cause, whichever came first, assessed up to 34 months.
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