Tranexamic Acid for Alloplastic Breast Reconstruction

Breast Cancer Clinical Trial

Official title:

Effects of Tranexamic Acid for Alloplastic Breast Reconstruction: A Randomized Control Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04918589
• Other study ID #: 13104
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: August 2022
• Est. completion date: August 2024

Study information

• Verified date: April 2022
• Source: McMaster University
• Contact: Minh Huynh, MD
• Phone: 9055221155
• Email: minh.huynh[@]medportal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hematoma is a common complication of alloplastic breast reconstruction. 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) assessing TXA use in alloplastic breast reconstruction, 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 alloplastic breast reconstruction 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.

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 alloplastic breast reconstruction. 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 reconstruction. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 106
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Are 18 years or older;

• Are undergoing one- or two-stage bilateral alloplastic breast reconstruction immediately after bilateral mastectomy 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;

• Alloplastic reconstruction is not performed immediately after mastectomy;

• Have a documented coagulopathy or bleeding disorder, acquired disturbances of colour vision, subarachnoid hemorrhage, hematuria, irregular menstrual bleeding, or seizure disorder.

Related Conditions & MeSH terms

• Breast Cancer
• Hematoma
• Hematoma Postoperative
• Tranexamic Acid

Intervention

Drug:
• Tranexamic acid
3 grams of tranexamic acid (30 mL of 100 mg/mL solution) diluted in 10 mL of normal saline
• Normal Saline
40 mL topical of 0.9% normal saline

Locations

Country	Name	City	State
Canada	Juravinski Hospital, Hamilton Health Sciences	Hamilton	Ontario
Canada	St. Joseph's Healthcare, Charlton Campus	Hamilton	Ontario
Canada	St. Joseph's Healthcare, King Campus	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

References & Publications (12)

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. — View Citation

Gomez-Barrena E, Ortega-Andreu M, Padilla-Eguiluz NG, Pérez-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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Knight H, Banks J, Muchmore J, Ives C, Green M. Examining the use of intraoperative tranexamic acid in oncoplastic breast surgery. Breast J. 2019 Sep;25(5):1047-1049. doi: 10.1111/tbj.13409. Epub 2019 Jun 11. — View Citation

Megson M. Traumatic subcutaneous haematoma causing skin necrosis. BMJ Case Rep. 2011 Jul 20;2011. pii: bcr0520114273. doi: 10.1136/bcr.05.2011.4273. — View Citation

Nelson JA, Fischer JP, Grover R, Cleveland E, Erdmann-Sager J, Serletti JM, Wu LC. The impact of anemia on microsurgical breast reconstruction complications and outcomes. Microsurgery. 2014 May;34(4):261-70. doi: 10.1002/micr.22202. Epub 2013 Nov 4. — View Citation

Pinsolle V, Grinfeder C, Mathoulin-Pelissier S, Faucher A. Complications analysis of 266 immediate breast reconstructions. J Plast Reconstr Aesthet Surg. 2006;59(10):1017-24. Epub 2006 Jun 5. — View Citation

Rogoff H, Marquez JE, Ghosh K, Jou C, McAuliffe P, Rathi S, Monroig K, Medrano C, Marmor WA, Ferrier A, Kapadia K, Klein G, Huston TL, Ganz J, Dagum AB, Khan S, Bui D. Clinical Outcomes After Hematoma Development: A Study of 627 Tissue Expander Breast Reconstructions. Ann Plast Surg. 2020 Jul;85(S1 Suppl 1):S63-S67. doi: 10.1097/SAP.0000000000002343. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematoma	Incidence rate of hematoma	2 weeks
Primary	Seroma	Incidence rate of seroma	2 weeks
Secondary	Drain output	Total drain output (mL) at 24 hours	24 hours
Secondary	Days with drains	Total number of days drains in situ with standard discharge criteria	2 weeks
Secondary	Reoperation rate	Number of repeat operations required for patient related to complication	2 weeks
Secondary	Reintervention rate	Rate of subsequent interventions including aspiration, repeat drain insertion or other	2 weeks
Secondary	Imaging findings	Ultrasound findings of hematoma or seroma, if applicable	2 weeks