Evaluation of TXA Prior to Surgery in the Geriatric Hip Fracture Population (TAHFT)
Primary Purpose
Hip Fractures
Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tranexamic Acid Injectable Solution
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hip Fractures focused on measuring Blood, Transfusion, Hip, Fracture, Surgery, Replacement, Trauma
Eligibility Criteria
Inclusion Criteria:
- Provision of written informed consent
- Age > or = to 65 years
- Hip fracture location within the femoral neck, intertrochanteric, and subtrochanteric regions
- Indication for one of the following surgical interventions: hemiarthroplasty, total hip replacement, sliding plate and screw fixation, or intramedullary fixation
Exclusion Criteria:
- Indication for closed reduction or percutaneous screw
- Allergy to TXA
- Cerebrovascular accident/stroke, active coronary disease/myocardial infarction, or deep vein thrombosis/pulmonary emboli within one (1) month of the fracture
- Presence of hypercoaguable disorder, including cancer (active disease), elevated blood homocysteine levels, antiphospholipid antibody syndrome and inherited protein deficiencies (antithrombin III, factor V Leiden, protein S & C deficiencies, prothrombin gene mutation)
Sites / Locations
- Lancaster General Heatlh / Penn Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Intervention
Placebo
Arm Description
100 cc normal saline with 1g of tranexamic acid in solution
100 cc normal saline
Outcomes
Primary Outcome Measures
Blood Transfusions
To compare the percentage of patients that receive acute post-operative transfusions in the group administered intravenous tranexamic acid compared to the group administered placebo.
Secondary Outcome Measures
Complication Rate
Determine if participants randomized to TXA experienced increased risk of complications compared to placebo. Complications include number of deep vein thrombosis events, pulmonary emboli events, myocardial infarction events, and cerebral vascular events within 12 weeks post hip fracture surgery.
Hospital Readmission
Determine differences between the groups in 30 day readmission rates.
Mortality Rate
Death within 90 days post hip surgery
Full Information
NCT ID
NCT03923959
First Posted
April 18, 2019
Last Updated
January 30, 2023
Sponsor
Lancaster General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03923959
Brief Title
Evaluation of TXA Prior to Surgery in the Geriatric Hip Fracture Population
Acronym
TAHFT
Official Title
Evaluation of Tranexamic Acid Prior to Surgery in the Geriatric Hip Fracture Population for the Reduction of Post-Operative Blood Transfusion
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lancaster General Hospital
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.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The overall design of the study is a prospective, double-blinded, randomized study in the geriatric hip fracture population comparing those who receive intravenous tranexamic acid prior to incision to those who receive a placebo.
Detailed Description
A significant portion of the geriatric hip fracture population have comorbidities including chronic kidney disease, congestive heart failure, ischemic heart disease, stroke, etc. These patients may be anemic prior to the surgery, and are at increased risk for further blood loss as a result of the fracture and surgical operation. However, intra-operative or post-operative blood transfusions also increase the risk of renal and cardiac complications in this population.
Tranexamic acid (TXA) is an anti-fibrinolytic medication that has transformed total joint replacement management regarding blood loss prevention. Geriatric patients requiring emergent hip fracture repair may significantly benefit from routine administration of TXA prior to the procedure to decrease the risk of blood loss. Thus, treatment may further reduce the percentage of patients who experience blood transfusions and complications associated with transfusions.
The investigators will examine if administration of TXA prior to incision in the geriatric hip fracture patient population decreases the risk of intra-operative or post-operative blood transfusions compared to placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
Keywords
Blood, Transfusion, Hip, Fracture, Surgery, Replacement, Trauma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
A prospective, double-blinded, randomized study in the geriatric hip fracture population comparing those who receive intravenous tranexamic acid prior to incision to those who receive a placebo.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
All OR pharmacists are un-blinded to subject randomization.
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
100 cc normal saline with 1g of tranexamic acid in solution
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
100 cc normal saline
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid Injectable Solution
Other Intervention Name(s)
Cyklokapron
Intervention Description
100 cc normal saline mixed with 1g of tranexamic acid in solution
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
100 cc normal saline
Primary Outcome Measure Information:
Title
Blood Transfusions
Description
To compare the percentage of patients that receive acute post-operative transfusions in the group administered intravenous tranexamic acid compared to the group administered placebo.
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Complication Rate
Description
Determine if participants randomized to TXA experienced increased risk of complications compared to placebo. Complications include number of deep vein thrombosis events, pulmonary emboli events, myocardial infarction events, and cerebral vascular events within 12 weeks post hip fracture surgery.
Time Frame
3 Months
Title
Hospital Readmission
Description
Determine differences between the groups in 30 day readmission rates.
Time Frame
30 Days
Title
Mortality Rate
Description
Death within 90 days post hip surgery
Time Frame
90 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of written informed consent
Age > or = to 65 years
Hip fracture location within the femoral neck, intertrochanteric, and subtrochanteric regions
Indication for one of the following surgical interventions: hemiarthroplasty, total hip replacement, sliding plate and screw fixation, or intramedullary fixation
Exclusion Criteria:
Indication for closed reduction or percutaneous screw
Allergy to TXA
Cerebrovascular accident/stroke, active coronary disease/myocardial infarction, or deep vein thrombosis/pulmonary emboli within one (1) month of the fracture
Presence of hypercoaguable disorder, including cancer (active disease), elevated blood homocysteine levels, antiphospholipid antibody syndrome and inherited protein deficiencies (antithrombin III, factor V Leiden, protein S & C deficiencies, prothrombin gene mutation)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Tocks, DO
Organizational Affiliation
Penn Medicine / Lancaster General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lancaster General Heatlh / Penn Medicine
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17602
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation of TXA Prior to Surgery in the Geriatric Hip Fracture Population
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