Mayo Clinic
Rochester, Minnesota, 55905, United States
NCT Number: NCT03182751
Intertrochanteric hip fractures typically result in blood loss from the fracture and require surgery that can cause further blood loss. This study is being done to look at a medication called tranexamic acid which may reduce blood loss and the need for blood transfusions associated with surgery.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Rochester, Minnesota, 55905, United States
The use of TXA in orthopedic trauma patients is an area of current research interest. A 2010 prospective randomized, controlled trial of perioperative TXA demonstrated reduction in transfusion requirements for intertrochanteric hip fractures treated with short, cephalomedullary nails. This was clinically, though not statistically, significant. Investigators recently conducted a randomized, controlled trial at this institution to evaluated the use of TXA in patients with femoral neck fractures treated with hemiarthroplasty or total hip arthroplasty and found clinically, albeit not statistically, significant reduction in transfusion requirement (accepted for publication). Perhaps tempering the effect seen with perioperative administration of TXA is the blood loss that occurs prior to surgery, the so-called "hidden" blood loss that can be as substantial as 1/3 of total blood loss from a hip fracture. This raises the question whether administration of tranexamic acid at the time of initial presentation after fracture could improve the perioperative care of these patients by decreasing the proportion of patients requiring transfusion and decreasing total blood loss.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours
Other names: Cyklokapron
Looks exactly like the study drug, but it contains no active ingredient
Time frame: Length of hospitalization (approximately 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.
Time frame: Length of hospitalization (approximately 3 to 5 days)
Number of units of packed red blood cells transfused per patient
Time frame: Length of hospitalization (approximately 3 to 5 days)
Total blood loss per patient measured in milliliters (mL)
Time frame: Within 6 months of surgery
Number of subjects to experience symptomatic Venous Thromboembolism (VTE)
Time frame: Within 6 months of surgery
Number of subjects diagnosed with a wound complication
Time frame: Within 6 months of surgery
Number of subjects diagnosed with a myocardial infarction
Time frame: Within 6 months of surgery
Number of subjects diagnosed with a cerebrovascular accident
Time frame: At 6 months after surgery
Number of subject deaths
Mayo Clinic
Other
Does Early Administration of Tranexamic Acid Reduce Blood Loss and Perioperative Transfusion Requirement in Low Energy Hip Fracture Patients?
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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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