Clinical trial NCT03182751: Does Early Administration of Tranexamic Acid Reduce Blood Loss and Perioperative Transfusion Requirement
Official title: Does Early Administration of Tranexamic Acid Reduce Blood Loss and Perioperative Transfusion Requirement in Low Energy Hip Fracture Patients?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hip Fractures
Intertrochanteric Fractures
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-06-09
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized into one of two study groups: TXA administration (treatment) or placebo (control). In order to ensure balance on the subject demographics between the two study groups, the subjects will be stratified on gender, age group (\<75 vs. ≥75) and body mass index (\<30 vs. ≥30). Within each stratum, subjects will be assigned to either the treatment group or control group using an electronic dynamic allocation program housed in a computer application developed by personnel in the Division of Biomedical Statistics and Informatics.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* AO/OTA fracture classification 31A
* Surgically treated with sliding hip screw or cephalomedullary nail (short or long)
* Low energy, isolated injury

Exclusion Criteria:

* Intracapsular hip fractures: AO/OTA fracture classification 31B-C
* Polytrauma patients
* Creatinine clearance less than 30 mL/min
* History of unprovoked VTE and/or recurrent VTE
* Known history of Factor V Leiden, protein C/S deficiency, prothrombin gene mutation, anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant
* Pregnancy or breastfeeding (pregnancy tests will be performed on all patients of child-bearing potential)
* History of CVA, MI, or VTE within the previous 30 days
* Coronary stent placement within the previous 6 months
* Disseminated intravascular coagulation
* Intracranial hemorrhage

Primary outcomes:
measure: Number of Subjects Transfused at Least 1 Unit of Packed Red Blood Cells
timeFrame: Length of hospitalization (approximately 3 to 5 days)
Secondary outcomes:
measure: Number of Units of Packed Red Blood Cells Transfused
timeFrame: Length of hospitalization (approximately 3 to 5 days)
measure: Calculated Blood Loss
timeFrame: Length of hospitalization (approximately 3 to 5 days)
measure: Number of Subjects to Experience Symptomatic Venous Thromboembolism (VTE)
timeFrame: Within 6 months of surgery
measure: Wound Complications
timeFrame: Within 6 months of surgery
measure: (Myocardial Infarction) MI Diagnosed
timeFrame: Within 6 months of surgery
measure: Cerebrovascular Accident (CVA) Diagnosed
timeFrame: Within 6 months of surgery
measure: All-cause Mortality
timeFrame: At 6 months after surgery
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Brandon Yuan, MD
role: PRINCIPAL_INVESTIGATOR
References: