Evaluation of TXA Prior to Surgery in the Geriatric Hip Fracture Population

Phase 3

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Provision of written informed consent
Age > or = to 65 years
Hip fracture location within the femoral neck, intertrochanteric, and subtrochanteric regions
Indication for one of the following surgical interventions: hemiarthroplasty, total hip replacement, sliding plate and screw fixation, or intramedullary fixation

Exclusion Criteria

Indication for closed reduction or percutaneous screw
Allergy to TXA
Cerebrovascular accident/stroke, active coronary disease/myocardial infarction, or deep vein thrombosis/pulmonary emboli within one (1) month of the fracture
Presence of hypercoaguable disorder, including cancer (active disease), elevated blood homocysteine levels, antiphospholipid antibody syndrome and inherited protein deficiencies (antithrombin III, factor V Leiden, protein S & C deficiencies, prothrombin gene mutation)

Arm && Interventions

Group	Intervention	Description
Intervention	Tranexamic Acid Injectable Solution	100 cc normal saline with 1g of tranexamic acid in solution
Placebo	Placebo	100 cc normal saline

Primary Outcome Measures

Name	Time	Method
Count of Participants With Acute Post-operative Transfusion of Packed Red Blood Cells.	3 Months	Count of participants with acute post-operative transfusion of packed red blood cells along with the corresponding 95% CI.

Secondary Outcome Measures

Name	Time	Method
Complication Rate	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	30 Days	Determine differences between the groups in 30 day readmission rates.
Mortality Rate	90 Days	Death within 90 days post hip surgery
Length of Stay	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.	Length of stay immediately post study intervention/surgery for hip fracture