Tranexamic Acid for Bleeding in Breast Surgery

NCT02615366 | Unknown Phase 4 DMC

• 1 other identifier: 20150264-01H
• Study Type: interventional
• Target: 800
• Locations: 0 countries
• Sites: N/A

Brief Summary

Bleeding is an important consideration in breast surgeries that involve large resections of soft tissues in the breast. Inappropriate bleeding during or after surgery, can lead to uncomfortable fluid buildup in the breasts known as a hematoma or seroma, which may require additional procedures or reoperation. Patients may experience a great deal of discomfort and additional costs as a result; additional hospital time and procedures also burdens health care spending. Tranexamic acid (TXA) is commonly used drug in many medical settings to reduce excessive bleeding; however, no such drug is standard practice in breast surgery. The aim of this study is to determine if TXA is superior to placebo in reducing the bleeding complications in breast surgeries, including reduction mammaplasty, mastectomy with and without immediate tissue expander and implant-based reconstruction, and oncoplastic breast surgery. This study is a randomized, double-blind, placebo-controlled trial. Patients undergoing these procedures will be randomly allocated to receive either TXA or placebo. Patients will be placed on a drug/placebo regimen of 3 doses/day for 6 days starting on the day of their surgery. The primary outcome is the incidence of hematoma and/or seroma formation following breast surgery. Cost analysis of the intervention will also be performed.

Conditions

Hematoma; Seroma

Outcome Measures

Primary Outcomes (1)

• Incidence of hematoma or seroma formation in breast surgical site as assessed by clinical examination.

  Hematoma or seroma formation in the breast surgical site(s) will be identified by surgeon on clinical examination during patient follow-up within 12 weeks post-operatively.

  12 weeks following the operation

Secondary Outcomes (7)

• Tranexamic Acid Adverse Events:

  12 weeks following the operation

• Drainage volume as measured from Jackson-Pratt drain or percutaneous drainage

  12 weeks following the operation

• Blood transfusion volume

  During surgical operating time, during post-operative hospital admission time (1-7 days on average).

• Incidence of secondary breast operation

  12 weeks following the operation

• Incidence of additional procedures following initial breast operation to address hematoma or seroma

  12 weeks following the operation

Study Arms (2)

Tranexamic Acid

ACTIVE COMPARATOR

Tranexamic acid will be provided as an intravenous infusion (1g in 100mL 0.9% NaCl solution \[1% TXA\] at 5 ml/min) 20 minutes pre-operatively, followed by an additional intravenous dose of the same dosing parameters postoperatively. Oral tablet doses containing 1 g of TXA (2x 500mg tablets) per dose will be administered to the patient to be taken orally by the patient according to a standard regimen; the first tablet dose will be taken on the same day as the surgery, in the evening. The patient will then take one tablet dose three times a day for a total of five days following the surgery (one dose in the morning, one dose mid-day, and one dose in the afternoon) for a 6 day total regimen.

Drug: Tranexamic Acid

Placebo Control

PLACEBO COMPARATOR

Placebo control will be either 100 ml of 0.9% NaCl solution or tablets of similar appearance containing no medicinal ingredients; placebo will be administered according to the same regimen as the intervention group.

Drug: Placebo

Interventions

Tranexamic Acid DRUG

Also known as: Cyklokapron

Tranexamic Acid

Placebo DRUG

Placebo Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient requires and is a candidate for any of the following surgical procedures: Reduction mammaplasty, mastectomy with and without immediate tissue expander and implant-based reconstruction, oncoplastic breast surgery.
• Patient has OHIP approval for surgery.
• Patient is willing and able (ie. English/French-speaking and cognitively intact) to read and complete patient diaries, demographic forms, and consent forms and be followed-up for a 2 weeks, 6 weeks, 12 weeks postoperatively.
• Patient is 18 years of age or older

You may not qualify if:

• Patient is allergic to tranexamic acid
• Patient has a history or present laboratory signs of bleeding disorders (abnormal platelet counts, prothrombin time, partial thromboplastin time, etc.), coagulopathy or thromboembolic events
• Patient is being treated for a stroke
• Patient has a history of bleeding in the brain
• Patient has an acquired disturbance of colour vision
• Patient has a history of myocardial infarction within the last year
• Patient is presenting with unstable angina or severe coronary disease
• Patient has reduced renal function with plasma creatinine levels above 250 umol/L ix.
• Patient has haematuria
• Patient is currently using a form of birth control that contains estrogen and a progestin
• Patient has irregular menstrual bleeding of unknown cause
• Patient is unable to complete required forms due to language and cognitive problems
• Patient is not capable of communicating in, and understanding, English or French
• Patient is currently pregnant and is expected to be pregnant during any point of the study

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Related Publications (11)

• Taylor JC, Rai S, Hoar F, Brown H, Vishwanath L. Breast cancer surgery without suction drainage: the impact of adopting a 'no drains' policy on symptomatic seroma formation rates. Eur J Surg Oncol. 2013 Apr;39(4):334-8. doi: 10.1016/j.ejso.2012.12.022. Epub 2013 Feb 4.

  PMID: 23380200 BACKGROUND

• de la Pena-Salcedo JA, Soto-Miranda MA, Lopez-Salguero JF. Prophylactic mastectomy: is it worth it? Aesthetic Plast Surg. 2012 Feb;36(1):140-8. doi: 10.1007/s00266-011-9769-x. Epub 2011 Jul 13.

  PMID: 21751064 BACKGROUND

• Lovely JK, Nehring SA, Boughey JC, Degnim AC, Donthi R, Harmsen WS, Jakub JW. Balancing venous thromboembolism and hematoma after breast surgery. Ann Surg Oncol. 2012 Oct;19(10):3230-5. doi: 10.1245/s10434-012-2524-y. Epub 2012 Jul 21.

  PMID: 22820939 BACKGROUND

• Alani HA, Balalaa N. Complete tissue expander coverage by musculo-fascial flaps in immediate breast mound reconstruction after mastectomy. J Plast Surg Hand Surg. 2013 Oct;47(5):399-404. doi: 10.3109/2000656X.2013.772060. Epub 2013 Jun 26.

  PMID: 23802185 BACKGROUND

• Lapid O, Pietersen L, van der Horst CM. Reoperation for haematoma after breast reduction with preoperative administration of low-molecular-weight heparin: experience in 720 patients. J Plast Reconstr Aesthet Surg. 2012 Nov;65(11):1513-7. doi: 10.1016/j.bjps.2012.05.027. Epub 2012 Jun 23.

  PMID: 22728066 BACKGROUND

• Pannucci CJ, Wachtman CF, Dreszer G, Bailey SH, Portschy PR, Hamill JB, Hume KM, Hoxworth RE, Kalliainen LK, Rubin JP, Pusic AL, Wilkins EG. The effect of postoperative enoxaparin on risk for reoperative hematoma. Plast Reconstr Surg. 2012 Jan;129(1):160-168. doi: 10.1097/PRS.0b013e318236215c.

  PMID: 21915085 BACKGROUND

• Carpelan A, Kauhanen S, Mattila K, Jahkola T, Tukiainen E. Reduction mammaplasty as an outpatient procedure: a retrospective analysis of outcome and success rate. Scand J Surg. 2015 Jun;104(2):96-102. doi: 10.1177/1457496914526872. Epub 2014 May 7.

  PMID: 24809356 BACKGROUND

• Xu Q, Yang Y, Shi P, Zhou J, Dai W, Yao Z, Zhang C. Repeated doses of intravenous tranexamic acid are effective and safe at reducing perioperative blood loss in total knee arthroplasty. Biosci Trends. 2014 Jun;8(3):169-75. doi: 10.5582/bst.2014.01063.

  PMID: 25030852 BACKGROUND

• Gillette BP, DeSimone LJ, Trousdale RT, Pagnano MW, Sierra RJ. Low risk of thromboembolic complications with tranexamic acid after primary total hip and knee arthroplasty. Clin Orthop Relat Res. 2013 Jan;471(1):150-4. doi: 10.1007/s11999-012-2488-z.

  PMID: 22814857 BACKGROUND

• Oertli D, Laffer U, Haberthuer F, Kreuter U, Harder F. Perioperative and postoperative tranexamic acid reduces the local wound complication rate after surgery for breast cancer. Br J Surg. 1994 Jun;81(6):856-9. doi: 10.1002/bjs.1800810621.

  PMID: 8044602 BACKGROUND

• Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG; CONSORT. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012;10(1):28-55. doi: 10.1016/j.ijsu.2011.10.001. Epub 2011 Oct 12.

  PMID: 22036893 BACKGROUND

MeSH Terms

Conditions

Hematoma; Seroma

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Inflammation

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Gloria Rockwell, MD

CONTACT

613-737-8899; office@plasticsurgerymd.ca

Daniel Waltho, BHSc, MD(c)

CONTACT

dwalt077@uottawa.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2015
• First Posted: November 26, 2015
• Study Start: February 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: January 12, 2016

Record last verified: 2016-01