Hip Fractures, Intertrochanteric Fractures
Conditions
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.
Interventions
DRUGTranexamic Acid (TXA)
Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours
DRUGPlacebo
Looks exactly like the study drug, but it contains no active ingredient
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Using dynamic allocation will ensure that the study subjects will remain balanced on the stratification factors and the treatment group assignment throughout the entire subject accrual phase. This system will be utilized by Central pharmacy personnel to generate the treatment group assignments. Medications will then be delivered from the Central Pharmacy to the emergency department in packaging that does not delineate whether it contains placebo or tranexamic acid. Thus, the patient, treating surgeon, emergency department physician, residents, hospitalist group, anesthesiologist, and data collectors will remain blinded to the treatment assignment.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Transfused at Least 1 Unit of Packed Red Blood Cells | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Calculated Blood Loss | Length of hospitalization (approximately 3 to 5 days) | Total blood loss per patient measured in milliliters (mL) |
| Number of Subjects to Experience Symptomatic Venous Thromboembolism (VTE) | Within 6 months of surgery | Number of subjects to experience symptomatic Venous Thromboembolism (VTE) |
| Wound Complications | Within 6 months of surgery | Number of subjects diagnosed with a wound complication |
| Number of Units of Packed Red Blood Cells Transfused | Length of hospitalization (approximately 3 to 5 days) | Number of units of packed red blood cells transfused per patient |
| Cerebrovascular Accident (CVA) Diagnosed | Within 6 months of surgery | Number of subjects diagnosed with a cerebrovascular accident |
| All-cause Mortality | At 6 months after surgery | Number of subject deaths |
| (Myocardial Infarction) MI Diagnosed | Within 6 months of surgery | Number of subjects diagnosed with a myocardial infarction |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tranexamic Acid Arm (TXA) Subjects will be treated with early administration of TXA in the Emergency Department
Tranexamic Acid (TXA): Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours | 64 |
| Control Arm Subjects will be treated with a placebo in the Emergency Department
Placebo: Looks exactly like the study drug, but it contains no active ingredient | 64 |
| Total | 128 |
Baseline characteristics
| Characteristic | Control Arm | Total | Tranexamic Acid Arm (TXA) |
|---|---|---|---|
| Age, Continuous | 79.69 years STANDARD_DEVIATION 12.7 | 79.39 years STANDARD_DEVIATION 13.1 | 79.1 years STANDARD_DEVIATION 13.5 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 64 participants | 128 participants | 64 participants |
| Sex: Female, Male Female | 45 Participants | 90 Participants | 45 Participants |
| Sex: Female, Male Male | 19 Participants | 38 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 7 / 64 | 6 / 64 |
| other Total, other adverse events | 0 / 64 | 0 / 64 |
| serious Total, serious adverse events | 8 / 64 | 7 / 64 |
Outcome results
Primary
Number of Subjects Transfused at Least 1 Unit of Packed Red Blood Cells
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tranexamic Acid Arm (TXA) | Number of Subjects Transfused at Least 1 Unit of Packed Red Blood Cells | 17 Participants |
| Control Arm | Number of Subjects Transfused at Least 1 Unit of Packed Red Blood Cells | 19 Participants |
Secondary
All-cause Mortality
Number of subject deaths
Time frame: At 6 months after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tranexamic Acid Arm (TXA) | All-cause Mortality | 7 Participants |
| Control Arm | All-cause Mortality | 6 Participants |
Secondary
Calculated Blood Loss
Total blood loss per patient measured in milliliters (mL)
Time frame: Length of hospitalization (approximately 3 to 5 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tranexamic Acid Arm (TXA) | Calculated Blood Loss | 1600 mL | Standard Deviation 1200 |
| Control Arm | Calculated Blood Loss | 2000 mL | Standard Deviation 1400 |
Secondary
Cerebrovascular Accident (CVA) Diagnosed
Number of subjects diagnosed with a cerebrovascular accident
Time frame: Within 6 months of surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tranexamic Acid Arm (TXA) | Cerebrovascular Accident (CVA) Diagnosed | 0 Participants |
| Control Arm | Cerebrovascular Accident (CVA) Diagnosed | 3 Participants |
Secondary
(Myocardial Infarction) MI Diagnosed
Number of subjects diagnosed with a myocardial infarction
Time frame: Within 6 months of surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tranexamic Acid Arm (TXA) | (Myocardial Infarction) MI Diagnosed | 0 Participants |
| Control Arm | (Myocardial Infarction) MI Diagnosed | 2 Participants |
Secondary
Number of Subjects to Experience Symptomatic Venous Thromboembolism (VTE)
Number of subjects to experience symptomatic Venous Thromboembolism (VTE)
Time frame: Within 6 months of surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tranexamic Acid Arm (TXA) | Number of Subjects to Experience Symptomatic Venous Thromboembolism (VTE) | 3 Participants |
| Control Arm | Number of Subjects to Experience Symptomatic Venous Thromboembolism (VTE) | 1 Participants |
Secondary
Number of Units of Packed Red Blood Cells Transfused
Number of units of packed red blood cells transfused per patient
Time frame: Length of hospitalization (approximately 3 to 5 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tranexamic Acid Arm (TXA) | Number of Units of Packed Red Blood Cells Transfused | 1.9 units of packed red blood cells | Standard Deviation 1.9 |
| Control Arm | Number of Units of Packed Red Blood Cells Transfused | 2.3 units of packed red blood cells | Standard Deviation 1.7 |
Secondary
Wound Complications
Number of subjects diagnosed with a wound complication
Time frame: Within 6 months of surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tranexamic Acid Arm (TXA) | Wound Complications | 4 Participants |
| Control Arm | Wound Complications | 1 Participants |