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
|Condition or disease||Intervention/treatment||Phase|
|Hematoma Seroma||Drug: Tranexamic Acid Drug: Placebo||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
- 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.
- 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
- Drainage volume as measured from Jackson-Pratt drain or percutaneous drainage [ Time Frame: 12 weeks following the operation ]
- Blood transfusion volume [ Time Frame: During surgical operating time, during post-operative hospital admission time (1-7 days on average). ]
- Incidence of secondary breast operation [ Time Frame: 12 weeks following the operation ]Surgical revision of initial breast procedure due to unsatisfactory results
- 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
- Number of days spent in hospital [ Time Frame: 12 weeks following the operation ]
- 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)
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
|Contact: Gloria Rockwell, MD||613-737-8899 ext firstname.lastname@example.org|
|Contact: Daniel Waltho, BHSc, MD(c)||email@example.com|