Does Early Administration of Tranexamic Acid Reduce Blood Loss and Perioperative Transfusion Requirement
Primary Purpose
Hip Fractures, Intertrochanteric Fractures
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tranexamic Acid (TXA)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hip Fractures
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
- Age greater than 18 years old
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
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Tranexamic Acid Arm (TXA)
Control Arm
Arm Description
Subjects will be treated with early administration of TXA in the Emergency Department
Subjects will be treated with a placebo in the Emergency Department
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of Units of Packed Red Blood Cells Transfused
Number of units of packed red blood cells transfused per patient
Calculated Blood Loss
Total blood loss per patient measured in milliliters (mL)
Number of Subjects to Experience Symptomatic Venous Thromboembolism (VTE)
Number of subjects to experience symptomatic Venous Thromboembolism (VTE)
Wound Complications
Number of subjects diagnosed with a wound complication
(Myocardial Infarction) MI Diagnosed
Number of subjects diagnosed with a myocardial infarction
Cerebrovascular Accident (CVA) Diagnosed
Number of subjects diagnosed with a cerebrovascular accident
All-cause Mortality
Number of subject deaths
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03182751
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 2, 2018 (Actual)
Primary Completion Date
May 24, 2022 (Actual)
Study Completion Date
May 24, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Intertrochanteric Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tranexamic Acid Arm (TXA)
Arm Type
Active Comparator
Arm Description
Subjects will be treated with early administration of TXA in the Emergency Department
Arm Title
Control Arm
Arm Type
Placebo Comparator
Arm Description
Subjects will be treated with a placebo in the Emergency Department
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid (TXA)
Other Intervention Name(s)
Cyklokapron
Intervention Description
Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Looks exactly like the study drug, but it contains no active ingredient
Primary Outcome Measure Information:
Title
Number of Subjects Transfused at Least 1 Unit of Packed Red Blood Cells
Description
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)
Secondary Outcome Measure Information:
Title
Number of Units of Packed Red Blood Cells Transfused
Description
Number of units of packed red blood cells transfused per patient
Time Frame
Length of hospitalization (approximately 3 to 5 days)
Title
Calculated Blood Loss
Description
Total blood loss per patient measured in milliliters (mL)
Time Frame
Length of hospitalization (approximately 3 to 5 days)
Title
Number of Subjects to Experience Symptomatic Venous Thromboembolism (VTE)
Description
Number of subjects to experience symptomatic Venous Thromboembolism (VTE)
Time Frame
Within 6 months of surgery
Title
Wound Complications
Description
Number of subjects diagnosed with a wound complication
Time Frame
Within 6 months of surgery
Title
(Myocardial Infarction) MI Diagnosed
Description
Number of subjects diagnosed with a myocardial infarction
Time Frame
Within 6 months of surgery
Title
Cerebrovascular Accident (CVA) Diagnosed
Description
Number of subjects diagnosed with a cerebrovascular accident
Time Frame
Within 6 months of surgery
Title
All-cause Mortality
Description
Number of subject deaths
Time Frame
At 6 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brandon Yuan, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
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Does Early Administration of Tranexamic Acid Reduce Blood Loss and Perioperative Transfusion Requirement
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