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Trial Title:
Impact of Topical Tranexamic Acid in Breast Reconstruction
NCT ID:
NCT05807074
Condition:
Breast Cancer
Conditions: Official terms:
Tranexamic Acid
Conditions: Keywords:
Breast Reconstruction
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tranexamic Acid
Description:
Applied intraoperatively
Arm group label:
TXA, Saline
Other name:
TXA
Other name:
Lysteda
Intervention type:
Other
Intervention name:
Saline
Description:
Applied intraoperatively
Arm group label:
TXA, Saline
Other name:
Saline solution
Other name:
Sodium Chloride 0.9%
Summary:
Improvement in bleeding and bruising has been described by using both intravenous and
topical off-label applications of Tranexamic Acid (TXA) in many surgical fields. This
trial tests how well applying tranexamic acid (TXA) to the surface of the surgical site
(topically) works to reduce post-operative bleeding (hematomas) and fluid collections
(seromas) in women undergoing surgery to remove both breasts (bilateral mastectomy)
immediately followed by surgery to rebuild the breast (reconstruction). The formation of
hematomas and seromas, a common post-mastectomy complication, can interfere with breast
reconstruction and increase the risk of infection and wound healing and can potentially
delay cancer treatments. TXA is a synthetic molecule that pushes the body's clotting
cascade toward clot formation to improve blood clotting. Applying TXA topically to the
surgical site before closing the incision may prevent hematoma and seroma formation in
post-mastectomy breast reconstruction patients.
Participants will be recruited from patients undergoing bilateral mastectomy at
University of California, San Francisco.
Detailed description:
PRIMARY OUTCOMES:
I. To investigate whether topical tranexamic acid may impact rates of seroma, hematoma,
severe bruising, and drain output in the post-mastectomy reconstructive population.
II. To evaluate the impact of TXA on seroma rates compared to control.
SECONDARY OUTCOMES:
I. To evaluate the impact of TXA on patient and provider rating of bruising, comparing
the TXA side to the control side.
II. To evaluate the impact of TXA on total drain output in the first post operative day.
III. To evaluate the impact of TXA on total drain duration.
OUTLINE:
Participants will only be treated intra-operatively at the time of surgery with topical
TXA to one breast pocket. Each participant will serve as own internal control, with one
side receiving saline and the other TXA. Participants in this study will be assessed at
their regularly scheduled visits up to one year post-operatively.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Histologically confirmed breast malignancy OR increased risk for breast cancer
2. Age >= 18 years
3. Scheduled to undergo bilateral mastectomy with plastic surgery closure or
reconstruction
4. Ability to understand a written informed consent document, and the willingness to
sign it
5. At least 4 weeks post-completion of chemotherapy or radiation therapy
Exclusion Criteria:
1. Any significant medical condition or laboratory abnormalities, which places the
subject at unacceptable risk if she were to participate in the study
2. Any history of thromboembolic disease
3. Current anticoagulant use
4. Current use of chlorpromazine due to label contraindication
5. Current use of any prothrombotic medical products due to label contraindication
6. Documented or reported allergic reaction to tranexamic acid
7. Male participants
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California, San Francisco
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Status:
Recruiting
Contact:
Last name:
Serena Bhaskerrao
Phone:
877-827-3222
Email:
Serena.Bhaskerrao@ucsf.edu
Contact backup:
Email:
cancertrials@ucsf.edu
Investigator:
Last name:
Merisa Piper, MD
Email:
Principal Investigator
Start date:
April 20, 2023
Completion date:
September 30, 2024
Lead sponsor:
Agency:
University of California, San Francisco
Agency class:
Other
Source:
University of California, San Francisco
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05807074
