- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04918576
Topical Tranexamic Acid for Bilateral Breast Reduction Surgery
A Randomized Control Trial Evaluating the Use of Topical Tranexamic Acid in Bilateral Breast Reduction Surgery to Prevent Bleeding Complications
Hematoma is a common complication of bilateral breast reduction (BBR) surgery. This can lead to pain and discomfort experienced by the patient, in addition to greater use of valuable healthcare resources. Previous studies have shown correlation between the use of tranexamic acid (TXA), an anti-fibrinolytic, and reduced post-surgical bleeding complication events.
In this randomized control trial (RCT) evaluation TXA use in BBR, for which one breast will be randomized to have TXA applied topically, while the other will have normal saline (NS) placebo applied. The primary objective of this prospective blinded randomized control trial study is to determine if the administration of topical TXA in BBR reduces the incidence of surgical site hematoma compared to placebo within 2 weeks following surgery. The results of this study will be used to inform the design of a larger multicentered RCT on TXA in breast surgery.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The primary objective of this study is to investigate the use of topical application of tranexamic Acid (TXA) to the surgical wound as a means to decrease hematoma formation compared to placebo in patients undergoing bilateral breast reduction (BBR). This project is designed as a single-center RCT to evaluate the effectiveness of topical TXA in this patient population.
If enrolled in this study, patients individual breasts will be randomly assigned to one of two treatment groups for to apply to the wound before it is closed. One breast will have an intravenous form of TXA applied topically to the surgical site. The other will be have a topical normal saline solution applied to the wound before closure (a placebo).
The patients will have the standard number of drains and postoperative instructions for breast reduction. They will follow-up at two weeks time in clinic for assessment, and emergency room visits will be also be evaluated. Standard of care will be practiced with respect to all procedures and visits.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Yaeesh Sardiwalla, MD
- Phone Number: 90505221155
- Email: yaeesh.sardiwalla@medportal.ca
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8G 5E4
- St. Joseph's Healthcare, King Campus
-
Contact:
- Mark McRae, MD, FRCSC
-
Hamilton, Ontario, Canada, L8N 4A6
- St. Joseph's Healthcare, Charlton Campus
-
Contact:
- Sophoceles Voineskos, MD, FRCSC
-
Hamilton, Ontario, Canada, L8V 1C3
- Juravinski Hospital, Hamilton Health Sciences
-
Contact:
- Christopher Coroneos, MD, FRCSC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Are 18 years or older;
- Are undergoing bilateral breast reduction at either Hamilton Health Sciences or St. Joseph's Hospital Hamilton.
Exclusion Criteria:
- Taking therapeutic anticoagulation;
- Taking antiplatelet drugs;
- Pregnant or breast feeding;
- Allergic to TXA;
- Cannot provide informed consent;
- Have a documented coagulopathy or bleeding disorder, acquired disturbances of colour vision, subarachnoid hemorrhage, hematuria, irregular menstrual bleeding, or seizure disorder.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tranexamic Acid
3 grams of tranexamic acid (30mL of 100 mg/mL solution) diluted in 10 mL of normal saline
|
3 grams of tranexamic acid (30mL of 100 mg/mL solution) diluted in 10 mL of normal saline
Other Names:
|
Placebo Comparator: Normal Saline
40 mL topical of 0.9% normal saline
|
40 mL topical of 0.9% normal saline
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hematoma
Time Frame: 2 weeks
|
Incidence rate of hematoma
|
2 weeks
|
Seroma
Time Frame: 2 weeks
|
Incidence rate of seroma
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Drain output
Time Frame: 24 hours
|
Total drain output (mL) at 24 hours
|
24 hours
|
Days with drains
Time Frame: 2 weeks
|
Total number of days drains in situ with standard discharge criteria
|
2 weeks
|
Reoperation rate
Time Frame: 2 weeks
|
Number of repeat operations required for patient related to complication
|
2 weeks
|
Reintervention rate
Time Frame: 2 weeks
|
Rate of subsequent interventions including aspiration, repeat drain insertion or other
|
2 weeks
|
Imaging findings
Time Frame: 2 weeks
|
Ultrasound findings of hematoma or seroma, if applicable
|
2 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christopher Coroneos, MD, FRCSC, McMaster University
Publications and helpful links
General Publications
- Ker K, Edwards P, Perel P, Shakur H, Roberts I. Effect of tranexamic acid on surgical bleeding: systematic review and cumulative meta-analysis. BMJ. 2012 May 17;344:e3054. doi: 10.1136/bmj.e3054.
- Wong J, Abrishami A, El Beheiry H, Mahomed NN, Roderick Davey J, Gandhi R, Syed KA, Muhammad Ovais Hasan S, De Silva Y, Chung F. Topical application of tranexamic acid reduces postoperative blood loss in total knee arthroplasty: a randomized, controlled trial. J Bone Joint Surg Am. 2010 Nov 3;92(15):2503-13. doi: 10.2106/JBJS.I.01518.
- Wang H, Shen B, Zeng Y. Comparison of topical versus intravenous tranexamic acid in primary total knee arthroplasty: a meta-analysis of randomized controlled and prospective cohort trials. Knee. 2014 Dec;21(6):987-93. doi: 10.1016/j.knee.2014.09.010. Epub 2014 Oct 23.
- Wind TC, Barfield WR, Moskal JT. The effect of tranexamic acid on blood loss and transfusion rate in primary total knee arthroplasty. J Arthroplasty. 2013 Aug;28(7):1080-3. doi: 10.1016/j.arth.2012.11.016. Epub 2013 Mar 28.
- Gomez-Barrena E, Ortega-Andreu M, Padilla-Eguiluz NG, Perez-Chrzanowska H, Figueredo-Zalve R. Topical intra-articular compared with intravenous tranexamic acid to reduce blood loss in primary total knee replacement: a double-blind, randomized, controlled, noninferiority clinical trial. J Bone Joint Surg Am. 2014 Dec 3;96(23):1937-44. doi: 10.2106/JBJS.N.00060.
- De Bonis M, Cavaliere F, Alessandrini F, Lapenna E, Santarelli F, Moscato U, Schiavello R, Possati GF. Topical use of tranexamic acid in coronary artery bypass operations: a double-blind, prospective, randomized, placebo-controlled study. J Thorac Cardiovasc Surg. 2000 Mar;119(3):575-80. doi: 10.1016/s0022-5223(00)70139-5.
- Ipema HJ, Tanzi MG. Use of topical tranexamic acid or aminocaproic acid to prevent bleeding after major surgical procedures. Ann Pharmacother. 2012 Jan;46(1):97-107. doi: 10.1345/aph.1Q383. Epub 2011 Dec 27.
- Derby BM, Grotting JC, Redden DT. Vertical Sculpted Pillar Reduction Mammaplasty in 317 Patients: Technique, Complications, and BREAST-Q Outcomes. Aesthet Surg J. 2016 Apr;36(4):417-30. doi: 10.1093/asj/sjv217. Epub 2016 Feb 23.
- DeFazio MV, Fan KL, Avashia YJ, Tashiro J, Ovadia S, Husain T, Camison L, Panthaki ZJ, Salgado CJ, Thaller SR. Inferior pedicle breast reduction: a retrospective review of technical modifications influencing patient safety, operative efficiency, and postoperative outcomes. Am J Surg. 2012 Nov;204(5):e7-14. doi: 10.1016/j.amjsurg.2012.07.015.
- Bauermeister AJ, Gill K, Zuriarrain A, Earle SA, Newman MI. "Reduction mammaplasty with superomedial pedicle technique: A literature review and retrospective analysis of 938 consecutive breast reductions". J Plast Reconstr Aesthet Surg. 2019 Mar;72(3):410-418. doi: 10.1016/j.bjps.2018.12.004. Epub 2018 Dec 14.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13103
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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