Breast CancerPhase 2NCT05554211
Tranexamic Acid Usage in Bilateral Mastectomy to Reduce Post-surgical Drainage
A Phase 2 study testing Tranexamic acid and Normal saline in people with Breast Cancer and BRCA Mutation, run by Northwestern University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, BRCA Mutation
- What is being tested?
- Tranexamic acid and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Jul 2022to 1 Jul 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female aged 18 years or older
- Scheduled or plans to schedule a bilateral mastectomy
- Able to understand informed consent and sign it voluntarily
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern Memorial Hospital
Chicago, Illinois, 60611
AMITA Health Saint Joseph Chicago
Chicago, Illinois, 60657
About this study
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.
Read the 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.
- Conditions
- Breast Cancer, BRCA Mutation
- Being tested
- Tranexamic acid, Normal saline
- Keywords
- mastectomy, tranexamic acid
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
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.
Normal salineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Breast | Experimental | Participants will receive 50 ml of TxA and gentamicin to the assigned experimental breast. Receives: Drug: Tranexamic acid |
| Control Breast | Placebo comparator | Participants will receive a standard irrigation of 50 ml of 0.9% NS and gentamicin to the assigned control breast. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drain output
The primary clinical endpoints in this study are the post-surgical drainage volume and drainage system indwelling time. Each drainage system will be removed post-operatively when the drainage amount is equal to or less than 30cc's for two consecutive 24-hour periods. Additionally, observations will be made regarding the post-surgical fluid accumulation, such as hematoma and seroma formation, and characterization of the fluid (bloody, purulent, serosanguinous, etc.)
Measured: Approximately 1 month post-operatively
Secondary outcomes (1)
Safety evaluation
The primary safety endpoint will be the development of previously noted side effects in studies of TxA usage - primarily headache, diarrhea and nausea predominantly associated with oral administration of TxA - as self-reported by the participants of those studies. Incidence of all side effects will be monitored.
Measured: Approximately 1 month post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start12 Jul 2022
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Why it stopped: Medical student graduated and stopped project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In a within-subjects design, one breast will receive normal saline control and the contralateral breast will receive tranexamic acid.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Saint Joseph Hospital, Chicago, Illinois, Northwestern Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Robert L Walton, MD, Principal investigator, Northwestern Feinberg School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554211
- Sponsor's protocol ID
- STU00214745
- Status last verified
- Sep 2023
- First submitted
- 21 Sep 2022
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hunt BJ. The current place of tranexamic acid in the management of bleeding. Anaesthesia. 2015 Jan;70 Suppl 1:50-3, e18. doi: 10.1111/anae.12910.
PubMed 25440395Dunn CJ, Goa KL. Tranexamic acid: a review of its use in surgery and other indications. Drugs. 1999 Jun;57(6):1005-32. doi: 10.2165/00003495-199957060-00017.
PubMed 10400410McCormack PL. Tranexamic acid: a review of its use in the treatment of hyperfibrinolysis. Drugs. 2012 Mar 26;72(5):585-617. doi: 10.2165/11209070-000000000-00000.
PubMed 22397329Draxler DF, Yep K, Hanafi G, Winton A, Daglas M, Ho H, Sashindranath M, Wutzlhofer LM, Forbes A, Goncalves I, Tran HA, Wallace S, Plebanski M, Myles PS, Medcalf RL. Tranexamic acid modulates the immune response and reduces postsurgical infection rates. Blood Adv. 2019 May 28;3(10):1598-1609. doi: 10.1182/bloodadvances.2019000092.
PubMed 31126915Lecker I, Wang DS, Whissell PD, Avramescu S, Mazer CD, Orser BA. Tranexamic acid-associated seizures: Causes and treatment. Ann Neurol. 2016 Jan;79(1):18-26. doi: 10.1002/ana.24558. Epub 2015 Dec 15.
PubMed 26580862Myckatyn TM, Tenenbaum MM. Discussion: Intravenous Tranexamic Acid in Implant-Based Breast Reconstruction Safely Reduces Hematoma without Thromboembolic Events. Plast Reconstr Surg. 2020 Aug;146(2):246-247. doi: 10.1097/PRS.0000000000006975. No abstract available.
PubMed 32740568Weissler JM, Banuelos J, Jacobson SR, Manrique OJ, Nguyen MT, Harless CA, Tran NV, Martinez-Jorge J. Intravenous Tranexamic Acid in Implant-Based Breast Reconstruction Safely Reduces Hematoma without Thromboembolic Events. Plast Reconstr Surg. 2020 Aug;146(2):238-245. doi: 10.1097/PRS.0000000000006967.
PubMed 32740567King, I. C., Mellington, A. J., Hazari, A., & Jones, M. E. (2019). Does tranexamic acid increase the risk of thromboembolic events in immediate or delayed breast reconstruction? A review of the literature. European Journal of Plastic Surgery, 42(6), 559-562. https://doi.org/10.1007/s00238-019-01527-9
Peitsidis P, Kadir RA. Antifibrinolytic therapy with tranexamic acid in pregnancy and postpartum. Expert Opin Pharmacother. 2011 Mar;12(4):503-16. doi: 10.1517/14656566.2011.545818. Epub 2011 Feb 4.
PubMed 21294602Jules-Elysee KM, Tseng A, Sculco TP, Baaklini LR, McLawhorn AS, Pickard AJ, Qin W, Cross JR, Su EP, Fields KG, Mayman DJ. Comparison of Topical and Intravenous Tranexamic Acid for Total Knee Replacement: A Randomized Double-Blinded Controlled Study of Effects on Tranexamic Acid Levels and Thrombogenic and Inflammatory Marker Levels. J Bone Joint Surg Am. 2019 Dec 4;101(23):2120-2128. doi: 10.2106/JBJS.19.00258.
PubMed 31800425Weissmann KA, Lafage V, Barrios Pitaque C, Lafage R, Descazeaux FM. Efficacy of topical versus intravenous tranexamic acid in spinal deformity. Eur Spine J. 2020 Dec;29(12):3044-3050. doi: 10.1007/s00586-020-06572-8. Epub 2020 Aug 31.
PubMed 32869162https://www.breastcancer.org/treatment/surgery/prophylactic_mast
Ausen K, Fossmark R, Spigset O, Pleym H. Randomized clinical trial of topical tranexamic acid after reduction mammoplasty. Br J Surg. 2015 Oct;102(11):1348-53. doi: 10.1002/bjs.9878.
PubMed 26349843Ausen K, Hagen AI, Ostbyhaug HS, Olafsson S, Kvalsund BJ, Spigset O, Pleym H. Topical moistening of mastectomy wounds with diluted tranexamic acid to reduce bleeding: randomized clinical trial. BJS Open. 2020 Apr;4(2):216-224. doi: 10.1002/bjs5.50248. Epub 2019 Dec 26.
PubMed 32207575Ausen K, Pleym H, Liu J, Hegstad S, Nordgard HB, Pavlovic I, Spigset O. Serum Concentrations and Pharmacokinetics of Tranexamic Acid after Two Means of Topical Administration in Massive Weight Loss Skin-Reducing Surgery. Plast Reconstr Surg. 2019 Jun;143(6):1169e-1178e. doi: 10.1097/PRS.0000000000005620.
PubMed 31136475
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid Usage in Bilateral Mastectomy to Reduce Post-surgical Drainage
- ClinicalTrials.gov ID
- NCT05554211
- Acronym / sponsor ID
- STU00214745
- Conditions
- Breast Cancer, BRCA Mutation
- Keywords
- mastectomy, tranexamic acid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Medical student graduated and stopped project
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Saint Joseph Hospital, Chicago, Illinois, Northwestern Memorial Hospital
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 26 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- In a within-subjects design, one breast will receive normal saline control and the contralateral breast will receive tranexamic acid.
| Arm | Type | Receives |
|---|---|---|
| Experimental Breast | Experimental | Drug: Tranexamic acidParticipants will receive 50 ml of TxA and gentamicin to the assigned experimental breast. |
| Control Breast | Placebo comparator | Drug: Normal salineParticipants will receive a standard irrigation of 50 ml of 0.9% NS and gentamicin to the assigned control breast. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female aged 18 years or older
- Scheduled or plans to schedule a bilateral mastectomy
- Able to understand informed consent and sign it voluntarily
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acidThe 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. | Drug | Experimental Breast |
| Normal salineThe 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. | Drug | Control Breast |
Primary outcome
Drain output
Time frame: Approximately 1 month post-operatively
The primary clinical endpoints in this study are the post-surgical drainage volume and drainage system indwelling time. Each drainage system will be removed post-operatively when the drainage amount is equal to or less than 30cc's for two consecutive 24-hour periods. Additionally, observations will be made regarding the post-surgical fluid accumulation, such as hematoma and seroma formation, and characterization of the fluid (bloody, purulent, serosanguinous, etc.)
1 secondary outcome
Safety evaluation
Time frame: Approximately 1 month post-operatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Background: PubMed 25440395Hunt BJ. The current place of tranexamic acid in the management of bleeding. Anaesthesia. 2015 Jan;70 Suppl 1:50-3, e18. doi: 10.1111/anae.12910.
- Background: PubMed 10400410Dunn CJ, Goa KL. Tranexamic acid: a review of its use in surgery and other indications. Drugs. 1999 Jun;57(6):1005-32. doi: 10.2165/00003495-199957060-00017.
- Background: PubMed 22397329McCormack PL. Tranexamic acid: a review of its use in the treatment of hyperfibrinolysis. Drugs. 2012 Mar 26;72(5):585-617. doi: 10.2165/11209070-000000000-00000.
- Background: PubMed 31126915Draxler DF, Yep K, Hanafi G, Winton A, Daglas M, Ho H, Sashindranath M, Wutzlhofer LM, Forbes A, Goncalves I, Tran HA, Wallace S, Plebanski M, Myles PS, Medcalf RL. Tranexamic acid modulates the immune response and reduces postsurgical infection rates. Blood Adv. 2019 May 28;3(10):1598-1609. doi: 10.1182/bloodadvances.2019000092.
- Background: PubMed 26580862Lecker I, Wang DS, Whissell PD, Avramescu S, Mazer CD, Orser BA. Tranexamic acid-associated seizures: Causes and treatment. Ann Neurol. 2016 Jan;79(1):18-26. doi: 10.1002/ana.24558. Epub 2015 Dec 15.
- Background: PubMed 32740568Myckatyn TM, Tenenbaum MM. Discussion: Intravenous Tranexamic Acid in Implant-Based Breast Reconstruction Safely Reduces Hematoma without Thromboembolic Events. Plast Reconstr Surg. 2020 Aug;146(2):246-247. doi: 10.1097/PRS.0000000000006975. No abstract available.
- Background: PubMed 32740567Weissler JM, Banuelos J, Jacobson SR, Manrique OJ, Nguyen MT, Harless CA, Tran NV, Martinez-Jorge J. Intravenous Tranexamic Acid in Implant-Based Breast Reconstruction Safely Reduces Hematoma without Thromboembolic Events. Plast Reconstr Surg. 2020 Aug;146(2):238-245. doi: 10.1097/PRS.0000000000006967.
- BackgroundKing, I. C., Mellington, A. J., Hazari, A., & Jones, M. E. (2019). Does tranexamic acid increase the risk of thromboembolic events in immediate or delayed breast reconstruction? A review of the literature. European Journal of Plastic Surgery, 42(6), 559-562. https://doi.org/10.1007/s00238-019-01527-9
- Background: PubMed 21294602Peitsidis P, Kadir RA. Antifibrinolytic therapy with tranexamic acid in pregnancy and postpartum. Expert Opin Pharmacother. 2011 Mar;12(4):503-16. doi: 10.1517/14656566.2011.545818. Epub 2011 Feb 4.
- Background: PubMed 31800425Jules-Elysee KM, Tseng A, Sculco TP, Baaklini LR, McLawhorn AS, Pickard AJ, Qin W, Cross JR, Su EP, Fields KG, Mayman DJ. Comparison of Topical and Intravenous Tranexamic Acid for Total Knee Replacement: A Randomized Double-Blinded Controlled Study of Effects on Tranexamic Acid Levels and Thrombogenic and Inflammatory Marker Levels. J Bone Joint Surg Am. 2019 Dec 4;101(23):2120-2128. doi: 10.2106/JBJS.19.00258.
- Background: PubMed 32869162Weissmann KA, Lafage V, Barrios Pitaque C, Lafage R, Descazeaux FM. Efficacy of topical versus intravenous tranexamic acid in spinal deformity. Eur Spine J. 2020 Dec;29(12):3044-3050. doi: 10.1007/s00586-020-06572-8. Epub 2020 Aug 31.
- Backgroundhttps://www.breastcancer.org/treatment/surgery/prophylactic_mast
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert L Walton, MD principal investigator
Northwestern Feinberg School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tranexamic acid and Normal saline in people with Breast Cancer and BRCA Mutation, run by Northwestern University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drain output (time frame: Approximately 1 month post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05554211, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.