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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic Acid Arm (TXA) | Active Comparator | Subjects will be treated with early administration of TXA in the Emergency Department |
|
| Control Arm | Placebo Comparator | Subjects will be treated with a placebo in the Emergency Department |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid (TXA) | Drug | Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Length of hospitalization (approximately 3 to 5 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Units of Packed Red Blood Cells Transfused | Number of units of packed red blood cells transfused per patient | Length of hospitalization (approximately 3 to 5 days) |
| Calculated Blood Loss |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brandon Yuan, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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We do not plan to share IPD with other researchers that are outside of the primary listed researchers within the primary institution where the investigation is being performed. While we intend the share the overall results of the study through peer review, we do not have our institution's IRB approval to share individual participant data outside of the institution.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Control Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Length of hospitalization (approximately 3 to 5 days) |
|
Adverse events were collected from baseline to end of study for a total of approximately 6 months on all participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep Vein Thrombosis (DVT) | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brandon Yuan | Mayo Clinic | 507-255-6112 | Yuan.Brandon@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 13, 2019 | Feb 17, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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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.
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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.
| Placebo | Drug | Looks exactly like the study drug, but it contains no active ingredient |
|
Total blood loss per patient measured in milliliters (mL)
| Length of hospitalization (approximately 3 to 5 days) |
| Number of Subjects to Experience Symptomatic Venous Thromboembolism (VTE) | Number of subjects to experience symptomatic Venous Thromboembolism (VTE) | Within 6 months of surgery |
| Wound Complications | Number of subjects diagnosed with a wound complication | Within 6 months of surgery |
| (Myocardial Infarction) MI Diagnosed | Number of subjects diagnosed with a myocardial infarction | Within 6 months of surgery |
| Cerebrovascular Accident (CVA) Diagnosed | Number of subjects diagnosed with a cerebrovascular accident | Within 6 months of surgery |
| All-cause Mortality | Number of subject deaths | At 6 months after surgery |
Subjects will be treated with a placebo in the Emergency Department Placebo: Looks exactly like the study drug, but it contains no active ingredient |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subjects will be treated with a placebo in the Emergency Department Placebo: Looks exactly like the study drug, but it contains no active ingredient |
|
|
| Secondary | Number of Units of Packed Red Blood Cells Transfused | Number of units of packed red blood cells transfused per patient | Posted | Mean | Standard Deviation | units of packed red blood cells | Length of hospitalization (approximately 3 to 5 days) |
|
|
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| Secondary | Calculated Blood Loss | Total blood loss per patient measured in milliliters (mL) | Posted | Mean | Standard Deviation | mL | Length of hospitalization (approximately 3 to 5 days) |
|
|
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| Secondary | Number of Subjects to Experience Symptomatic Venous Thromboembolism (VTE) | Number of subjects to experience symptomatic Venous Thromboembolism (VTE) | Posted | Count of Participants | Participants | Within 6 months of surgery |
|
|
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| Secondary | Wound Complications | Number of subjects diagnosed with a wound complication | Posted | Count of Participants | Participants | Within 6 months of surgery |
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| Secondary | (Myocardial Infarction) MI Diagnosed | Number of subjects diagnosed with a myocardial infarction | Posted | Count of Participants | Participants | Within 6 months of surgery |
|
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| Secondary | Cerebrovascular Accident (CVA) Diagnosed | Number of subjects diagnosed with a cerebrovascular accident | Posted | Count of Participants | Participants | Within 6 months of surgery |
|
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| Secondary | All-cause Mortality | Number of subject deaths | Posted | Count of Participants | Participants | At 6 months after surgery |
|
|
|
| 7 |
| 64 |
| 8 |
| 64 |
| 0 |
| 64 |
| EG001 | 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 | 6 | 64 | 7 | 64 | 0 | 64 |
| Pulmonary Embolism (PE) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Stroke | Nervous system disorders | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
|
| Wound Complication | Surgical and medical procedures | Systematic Assessment |
|
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| D007869 |
| Leg Injuries |