Trial Title:
Tranexamic Acid Usage in Bilateral Mastectomy to Reduce Post-surgical Drainage
NCT ID:
NCT05554211
Condition:
Breast Cancer
BRCA Mutation
Conditions: Official terms:
Tranexamic Acid
Conditions: Keywords:
mastectomy
tranexamic acid
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
In a within-subjects design, one breast will receive normal saline control and the
contralateral breast will receive tranexamic acid.
Primary purpose:
Treatment
Masking:
Single (Investigator)
Masking description:
Each solution (topical saline irrigation vs. TxA) will be prepared by the hospital
pharmacy on the day of the procedure and given a blinded code number so that the surgeons
and study's investigators will be blinded to which breast received which solution. A
randomization table will be used to determine whether the right or left breast receives
TxA for each patient. Each wound, whether treated with the control agent of TxA, will be
irrigated with gentamicin.
The labeling and volume of both the TxA and control irrigation syringes will be visually
identical for blinding purposes with the exception of the label indicating whether the
syringe is for the "right" or "left" breast. Two pharmacy staff members will check the
breast assignment on the label against the randomization table. Each label will contain
the patient's subject ID number and the study protocol number.
Intervention:
Intervention type:
Drug
Intervention name:
Tranexamic acid
Description:
The intervention is a topical application of 50 cc's of 3% tranexamic acid. In the
operating room, TxA irrigation will be administered following gentamicin irrigation. TxA
irrigation solution will be the last irrigation used prior to wound closure in order to
assure maximum benefit derived from TxA administration, if any.
Arm group label:
Experimental Breast
Intervention type:
Drug
Intervention name:
Normal saline
Description:
The intervention is a topical application of 50 cc's of 3% tranexamic acid. In the
operating room, control normal saline (NS) irrigation will be administered following
gentamicin irrigation. NS irrigation solution will be the last irrigation used prior to
wound closure in order to assure maximum benefit derived from TxA administration, if any.
Arm group label:
Control Breast
Summary:
Tranexamic acid (TxA) is a drug that was approved by the FDA in 1986. It is an
antifibrinolytic drug - this means that it is used to promote blood clotting by
preventing the breakdown of blood clots that the participant's body naturally forms. TxA
is very commonly used to control bleeding in a variety of surgeries, such as orthopedic
and gynecologic procedures, and is available in both the injectable (delivering the drug
through the veins) and oral forms. However, its use is still not commonplace in the
setting of elective breast surgery, because it hasn't been extensively studied in this
field. Because it is not currently FDA-approved for use in elective breast surgery, this
would make the drug "investigational" for this study. Because of its current use in other
fields, TxA seems to have a great deal of potential in reducing the amount of
post-operative time that breast drains need to be kept in place, the frequency of adverse
events during wound healing such as bleeding and fluid accumulation, and overall fluid
drainage amount. This would serve to improve the overall process of post-operative
healing following a mastectomy procedure. Currently, the use of TxA is approved through
the injectable route at Northwestern, but it is not approved for administration by the
topical route. Previous studies have shown that TxA given through the topical route of
administration in breast reduction surgery reduced post-surgical drainage and fluid
accumulation. In this study, the use of 3% (3 grams of TxA in 100 ml of saline) TxA
through the topical route by applying it to the breast wound of one breast as a direct
fluid irrigation will be investigated. This will be done as a fluid wash, where the TxA
will be in a syringe, and just before wound closure the TxA will be sprayed onto the
wound site. The other breast will undergo the same procedure, but will receive normal
saline solution instead of TxA. The procedure of interest here is a prophylactic
bilateral mastectomy, which is a mastectomy that is performed to prevent the occurrence
of breast cancer. The purpose of this study is to test whether applying TxA topically
during wound closure in mastectomy procedures will affect the quantity of fluid
accumulation and bleeding, and the amount of time that post-operative drains need to be
kept in place.
Detailed description:
Breast cancer is the second most common cancer among women in the United States.
Mastectomy procedures are often performed to treat breast cancer, and may either be done
prophylactically or therapeutically. Women with either a strong family history of breast
cancer and/or a positive mutation for the breast cancer susceptibility genes BRCA1 or
BRCA2 may elect to undergo a prophylactic mastectomy, in which one or both breasts are
removed. Such procedures have been found to reduce the risk of developing breast cancer
in these individuals by 90-95%. This process often begins with an individual who has a
family member or relative that has tested positive for a BRCA mutation or developed
breast cancer. Female family members may then choose to undergo screening to identify
whether they carry such a genetic mutation themselves, and if any family member screens
positive for the mutation, one may solicit a plastic surgeon for the mastectomy to
prevent future breast cancer occurrence. Additionally, women may elect to undergo a
mastectomy after the development of cancer in one or both breasts. In the event of cancer
development in one breast, patients may choose to undergo a bilateral mastectomy
therapeutically in the breast with cancer and prophylactically in the breast without
cancer to prevent future cancer development in the non-cancer breast.
During mastectomy procedures, tumescent solution is commonly used for regional anesthesia
and reduction of blood loss through potent vasoconstriction. Tumescent solution is an
infiltration solution (a formula consisting of epinephrine, lidocaine in Lactated
Ringer's solution diluted in saline) that usually contains 0.05% lidocaine and
1:1,000,000 epinephrine. While there are several studies investigating various modified
recipe of tumescent solution during bilateral risk-reducing mastectomy (BRRM) with the
goal of reducing perioperative bleeding, the results remain inconsistent.
In this study, the use of TxA in bilateral mastectomy in a cohort of female patients will
be investigated. TxA is an anti-fibrinolytic agent commonly used to control trauma and
menstrual bleeding, as well as in routine surgical procedures. In prior studies, TxA has
been shown to reduce mortality due to adverse bleeding events by one-third1. In addition,
TxA mechanism-of-action has been shown to exert an immunomodulatory effect that results
in reduced infection rates independent of its effect on reduction of blood loss4. Because
of this, TxA has become an attractive agent for use in surgery to control bleeding during
procedures and post-surgical fluid accumulation at the wound site. However, its use is
still not commonplace in the setting of elective breast surgery.
During breast surgery, agents such as tumescent solution are commonly administered to
reduce peri-operative bleeding and post-surgical blood and fluid accumulation. Following
surgery, drainage systems such as Jackson-Pratt drains are placed within the breast to
allow for fluid removal and prevent the incidence of infection, hematoma, and seroma. To
date, few studies have investigated the perioperative use of TxA during breast surgery to
reduce post-surgical fluid drainage and reduction of corresponding adverse events - as a
result, the investigators believe that there is a great deal of potential in this
investigation to inform future surgical practices in this field and to improve patients'
quality-of-life. In this study, the investigators will conduct a prospective study of
female patients undergoing bilateral mastectomy to determine the effect of TxA
administration in reducing post-surgical breast drainage and indwelling time and
preventing adverse fluid accumulation-related events.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Female aged 18 years or older
- Scheduled or plans to schedule a bilateral mastectomy
- Able to understand informed consent and sign it voluntarily
Exclusion Criteria:
- Male without breasts
- Females who have previously undergone either unilateral or bilateral mastectomy as
they do not have breasts on which the drug could be tested
- Patients with a hypersensitive or allergic reaction to TxA
- Patients with an active clotting disorder
- Patients with a subarachnoid hemorrhage within the past 3 months of screening
- Patients on chronic, extracorporeal renal replacement therapy
Gender:
Female
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Northwestern Memorial Hospital
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Recruiting
Facility:
Name:
AMITA Health Saint Joseph Chicago
Address:
City:
Chicago
Zip:
60657
Country:
United States
Status:
Recruiting
Start date:
July 12, 2022
Completion date:
December 2024
Lead sponsor:
Agency:
Northwestern University
Agency class:
Other
Collaborator:
Agency:
Saint Joseph Hospital, Chicago, Illinois
Agency class:
Other
Collaborator:
Agency:
Northwestern Memorial Hospital
Agency class:
Other
Source:
Northwestern University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05554211
