Back to resultsTopical (Intra-Articular) Tranexamic Acid and Transfusion Rates Following Hip Hemiarthroplasty
Primary Purpose
Femoral Neck Fractures
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tranexamic Acid
Placebo (saline)
Sponsored by
About this trial
This is an interventional treatment trial for Femoral Neck Fractures focused on measuring Hip Hemiarthroplasty, Tranexamic Acid, Topical, Blood Transfusion
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing hip hemiarthroplasty surgery for a displaced femoral neck fracture
Exclusion Criteria:
- History of hemophilia, history of deep vein thrombosis, history of pulmonary embolism, history of thrombophilia, history of chronic renal failure
- Patients with coronary ischemia (active or within the past calendar year), patients who have suffered a myocardial infarction, undergone percutaneous coronary intervention, undergone coronary artery bypass grafting, or undergone any revascularization procedure within the past calendar year
- Patients with active subarachnoid hemorrhage, acquired defective color vision, patients who sustained a pathologic fracture (fracture through a neoplastic lesion), or patients who are pregnant
- Patients with a known allergy to tranexamic acid
- Patients taking Warfarin, Dabigatran, Rivaroxaban, Apixaban, and Fresh Frozen Plasma
Sites / Locations
- University of Connecticut Health Center
- Saint Francis Hospital and Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tranexamic Acid
Placebo
Arm Description
Patients will receive 1 gram of topically applied tranexamic acid into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. 1 gram of tranexamic acid will be mixed with normal saline to a total volume of 50 cc, half of which will be delivered intra-articularly and half of which will be delivered in the subfascial space.
Patients will receive 50 cc of topically applied normal saline into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. Half of this 50 cc dose of normal saline will be delivered intra-articularly and half will be delivered in the subfascial space.
Outcomes
Primary Outcome Measures
Number of Participants Who Needed Transfusions
The rate of transfusion will be calculated for each study group.
Secondary Outcome Measures
Inpatient Transfusion Amount
The transfusion amount will be calculated for each study group.
Difference Between Pre/Post-operative Hemoglobin
Difference Between Pre/Post-operative Hematocrit
Length of Inpatient Hospital Stay
Number of Participants With Post-operative Complications
Inpatient Hospitalization Cost
Full Information
NCT ID
NCT02664909
First Posted
January 13, 2016
Last Updated
July 20, 2021
Sponsor
UConn Health
Collaborators
Orthopaedic Research and Education Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02664909
Brief Title
Topical (Intra-Articular) Tranexamic Acid and Transfusion Rates Following Hip Hemiarthroplasty
Official Title
Topical (Intra-Articular) Tranexamic Acid and Transfusion Rates Following Hip Hemiarthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UConn Health
Collaborators
Orthopaedic Research and Education Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is a double-blinded placebo-controlled clinical trial evaluating the efficacy of 1 gram of topically applied tranexamic acid vs. saline placebo for the reduction of transfusion following hip hemiarthroplasty surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fractures
Keywords
Hip Hemiarthroplasty, Tranexamic Acid, Topical, Blood Transfusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tranexamic Acid
Arm Type
Experimental
Arm Description
Patients will receive 1 gram of topically applied tranexamic acid into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. 1 gram of tranexamic acid will be mixed with normal saline to a total volume of 50 cc, half of which will be delivered intra-articularly and half of which will be delivered in the subfascial space.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive 50 cc of topically applied normal saline into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. Half of this 50 cc dose of normal saline will be delivered intra-articularly and half will be delivered in the subfascial space.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Intervention Type
Drug
Intervention Name(s)
Placebo (saline)
Primary Outcome Measure Information:
Title
Number of Participants Who Needed Transfusions
Description
The rate of transfusion will be calculated for each study group.
Time Frame
From the time of surgery until 2-4 days post-operative (length of inpatient hospital stay)
Secondary Outcome Measure Information:
Title
Inpatient Transfusion Amount
Description
The transfusion amount will be calculated for each study group.
Time Frame
2-4 days post-operative (length of inpatient hospital stay)
Title
Difference Between Pre/Post-operative Hemoglobin
Time Frame
Pre-operative hemoglobin level vs. post-operative day 1 hemoglobin level
Title
Difference Between Pre/Post-operative Hematocrit
Time Frame
Pre-operative hematocrit level vs. post-operative day 1 hematocrit level
Title
Length of Inpatient Hospital Stay
Time Frame
From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever comes first, assessed up to 42 days post-operatively
Title
Number of Participants With Post-operative Complications
Time Frame
Admission to second post-operative visit (4-6 weeks post-operative)
Title
Inpatient Hospitalization Cost
Time Frame
Collected 4-6 weeks post-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing hip hemiarthroplasty surgery for a displaced femoral neck fracture
Exclusion Criteria:
History of hemophilia, history of deep vein thrombosis, history of pulmonary embolism, history of thrombophilia, history of chronic renal failure
Patients with coronary ischemia (active or within the past calendar year), patients who have suffered a myocardial infarction, undergone percutaneous coronary intervention, undergone coronary artery bypass grafting, or undergone any revascularization procedure within the past calendar year
Patients with active subarachnoid hemorrhage, acquired defective color vision, patients who sustained a pathologic fracture (fracture through a neoplastic lesion), or patients who are pregnant
Patients with a known allergy to tranexamic acid
Patients taking Warfarin, Dabigatran, Rivaroxaban, Apixaban, and Fresh Frozen Plasma
Facility Information:
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Saint Francis Hospital and Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Topical (Intra-Articular) Tranexamic Acid and Transfusion Rates Following Hip Hemiarthroplasty
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