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Tranexamic Acid for Bleeding in Breast Surgery (TABBS)

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ClinicalTrials.gov Identifier: NCT02615366
Recruitment Status : Unknown
Verified January 2016 by Ottawa Hospital Research Institute.
Recruitment status was:  Not yet recruiting
First Posted : November 26, 2015
Last Update Posted : January 12, 2016
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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.

Condition or disease Intervention/treatment Phase
Hematoma Seroma Drug: Tranexamic Acid Drug: Placebo Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Minimization of Bleeding Complications Through Utilization of Perioperative Tranexamic Acid in Breast Surgery: A Randomized Double-blinded Placebo-controlled Trial
Study Start Date : February 2016
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Active Comparator: Tranexamic Acid
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
Other Name: Cyklokapron

Placebo Comparator: Placebo Control
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



Primary Outcome Measures :
  1. Incidence of hematoma or seroma formation in breast surgical site as assessed by clinical examination. [ Time Frame: 12 weeks following the operation ]
    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.


Secondary Outcome Measures :
  1. Tranexamic Acid Adverse Events: [ Time Frame: 12 weeks following the operation ]
    Includes allergic and/or anaphylactic reactions, eye or eyesight problems, thromboembolic events, diarrhoea, gastrointestinal problems, hypersensitivity reactions, nausea and vomiting

  2. Drainage volume as measured from Jackson-Pratt drain or percutaneous drainage [ Time Frame: 12 weeks following the operation ]
  3. Blood transfusion volume [ Time Frame: During surgical operating time, during post-operative hospital admission time (1-7 days on average). ]
  4. Incidence of secondary breast operation [ Time Frame: 12 weeks following the operation ]
    Surgical revision of initial breast procedure due to unsatisfactory results

  5. Incidence of additional procedures following initial breast operation to address hematoma or seroma [ Time Frame: 12 weeks following the operation ]
    Operative or non-operative procedures to correct hematoma or seroma in the breast surgical site

  6. Number of days spent in hospital [ Time Frame: 12 weeks following the operation ]
  7. Cost associated with bleeding complications [ Time Frame: 12 weeks following the operation ]
    Additional cost of original procedure (including material costs, as well as OR time, surgeon, anesthetist, and nurse costs), cost per day spent in hospital, cost for additional care (including procedures, medication, etc.), patient/caregiver out-of-pocket expenses (dressings and medications, parking, transportation, days missed from work)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02615366


Contacts
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Contact: Gloria Rockwell, MD 613-737-8899 ext 71087 office@plasticsurgerymd.ca
Contact: Daniel Waltho, BHSc, MD(c) dwalt077@uottawa.ca

Sponsors and Collaborators
Ottawa Hospital Research Institute

Publications:

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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02615366     History of Changes
Other Study ID Numbers: 20150264-01H
First Posted: November 26, 2015    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Hematoma
Hemorrhage
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants