Lancaster General Heatlh / Penn Medicine
Lancaster, Pennsylvania, 17602, United States
NCT Number: NCT03923959
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.
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Notify Me65 year and older
All sexes
Interventional
Phase 3
Lancaster, Pennsylvania, 17602, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
100 cc normal saline mixed with 1g of tranexamic acid in solution
Other names: Cyklokapron
100 cc normal saline
Time frame: 3 Months
Count of participants with acute post-operative transfusion of packed red blood cells along with the corresponding 95% CI.
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.
Time frame: 30 Days
Determine differences between the groups in 30 day readmission rates.
Time frame: 90 Days
Death within 90 days post hip surgery
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.
Length of stay immediately post study intervention/surgery for hip fracture
Lancaster General Hospital
Other
Evaluation of Tranexamic Acid Prior to Surgery in the Geriatric Hip Fracture Population for the Reduction of Post-Operative Blood Transfusion
Acronym: TAHFT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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