Back to resultsA Randomized Control Trial Assessing the Effect of Topical Tranexamic Acid on Risk of Hematoma in Breast Surgery
Primary Purpose
Hematoma Postoperative
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tranexamic acid injection
No additional irrigation
Sponsored by
About this trial
This is an interventional treatment trial for Hematoma Postoperative focused on measuring Breast reduction, Gender-affirming mastectomy, Tranexamic Acid
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing bilateral breast reduction or bilateral gender-affirming mastectomy
- For patients undergoing bilateral breast reduction, any skin incision pattern or pedicle is acceptable.
- For patients undergoing bilateral gender-affirming mastectomy, any skin incision and mastectomy type is acceptable
Exclusion Criteria:
- Active thromboembolic disease or history of intrinsic risk of thrombosis or thromboembolism, including retinal vein or artery occlusion
- Current use of systemic anticoagulation
- Hypersensitivity to tranexamic acid
- Concomitant use of combined hormonal contraceptives
- Use of factor IX complex concentrates, anti-inhibitor coagulant concentrates or all-trans retinoic acid
- History of acquired defective color vision
- History of subarachnoid hemorrhage
- Pregnancy
- History of renal impairment or serum Creatinine >1.5 milligrams per deciliter (mg/dL)
Sites / Locations
- University of MichiganRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Irrigation that contains tranexamic acid (TXA)
No additional irrigation usual care
Arm Description
Outcomes
Primary Outcome Measures
Incidence of Hematomas requiring operative washout or aspiration in participants that receive TXA versus participants that do not receive TXA
Secondary Outcome Measures
Number of participants experiencing a major thromboembolic event related to the study drug
Major thromboembolic events include, but are not limited to: deep vein thrombosis, pulmonary embolism, stroke
Number of participants experiencing major complications other than hematoma
Major complications include, but are not limited to: infection, seroma, hypersensitivity reaction to TXA, renal impairment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05441592
Brief Title
A Randomized Control Trial Assessing the Effect of Topical Tranexamic Acid on Risk of Hematoma in Breast Surgery
Official Title
A Randomized Control Trial Assessing the Effect of Topical Tranexamic Acid on Risk of Hematoma in Breast Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
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
5. Study Description
Brief Summary
This trial is being completed to evaluate the safety and efficacy of topical tranexamic acid use in preventing hematomas in routine breast plastic surgery operations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematoma Postoperative
Keywords
Breast reduction, Gender-affirming mastectomy, Tranexamic Acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Irrigation that contains tranexamic acid (TXA)
Arm Type
Experimental
Arm Title
No additional irrigation usual care
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid injection
Intervention Description
The breast pockets will additionally be irrigated with 150 cc of 2.67% TXA (75 cc in each breast). The TXA solution will be allowed to be sit in the breast pocket for 15 minutes and then removed after 15 minutes.
Intervention Type
Other
Intervention Name(s)
No additional irrigation
Intervention Description
There will be no additional irrigation after the standard surgical procedure.
Primary Outcome Measure Information:
Title
Incidence of Hematomas requiring operative washout or aspiration in participants that receive TXA versus participants that do not receive TXA
Time Frame
Up to approximately 4 weeks after surgery
Secondary Outcome Measure Information:
Title
Number of participants experiencing a major thromboembolic event related to the study drug
Description
Major thromboembolic events include, but are not limited to: deep vein thrombosis, pulmonary embolism, stroke
Time Frame
Up to approximately 4 weeks after surgery
Title
Number of participants experiencing major complications other than hematoma
Description
Major complications include, but are not limited to: infection, seroma, hypersensitivity reaction to TXA, renal impairment
Time Frame
Up to approximately 4 weeks after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing bilateral breast reduction or bilateral gender-affirming mastectomy
For patients undergoing bilateral breast reduction, any skin incision pattern or pedicle is acceptable.
For patients undergoing bilateral gender-affirming mastectomy, any skin incision and mastectomy type is acceptable
Exclusion Criteria:
Active thromboembolic disease or history of intrinsic risk of thrombosis or thromboembolism, including retinal vein or artery occlusion
Current use of systemic anticoagulation
Hypersensitivity to tranexamic acid
Concomitant use of combined hormonal contraceptives
Use of factor IX complex concentrates, anti-inhibitor coagulant concentrates or all-trans retinoic acid
History of acquired defective color vision
History of subarachnoid hemorrhage
Pregnancy
History of renal impairment or serum Creatinine >1.5 milligrams per deciliter (mg/dL)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherry Tang, MD
Phone
734-936-5895
Email
syqtang@med.umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jenni Hamill, MPH
Email
Jenberry@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edwin Wilkins, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherry Tang, MD
Phone
734-936-5895
Email
syqtang@umich.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Randomized Control Trial Assessing the Effect of Topical Tranexamic Acid on Risk of Hematoma in Breast Surgery
We'll reach out to this number within 24 hrs