A Phase 4 interventional study of Tranexamic Acid 100mg/mL, 20mL topical and Normal Saline Flush, 0.9%, 20mL topical in Seroma Complicating A Procedure, Hematoma Postoperative and Breast Cancer, sponsored by Hamilton Health Sciences Corporation. Status unknown at 2 sites in Canada. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-02-21.
Sponsored by Hamilton Health Sciences Corporation · Phase 4, Interventional, and Prevention
This is a pilot study to evaluate the feasibility of conducting a larger trial to determine if the use of intraoperative topical tranexamic acid (TXA) decreases the rate of post-operative hematomas and seromas in breast cancer patients after their mastectomy. In other words, the investigators want to determine if applying TXA inside the surgical wound before it is closed helps reduce blood or serous fluid accumulation at the operative site. Dependent on the results of this study, a further larger trial may or may not take place.
Post-operative seromas and hematomas are common complications of mastectomy surgery not only leading to infection, discomfort, wound dehiscence or emergency room visits; they also delay in some instances post-operative adjuvant radiotherapy. Establishing whether or not topical TXA is an effective strategy to decrease those complications can potentially impact positively the breast cancer treatment.
To achieve this aim, this randomized pilot study will first determine whether a larger multicenter study if feasible. This study will replicate a formal randomized trial at a smaller scale in a single center in order to assess the recruitment and randomization process, as well as provide preliminary results for our research question.
The objective of this study is to investigate the novel use of topical application of Tranexamic Acid (TXA) to the surgical wound as a means to decrease seroma and/or hematoma formation compared to placebo in post-mastectomy patients. This project is designed as a single-center pilot RCT to evaluate the feasibility of conducting a formal RCT (multicenter trial including more patients) to evaluate the effectiveness of topical TXA.
Patients will be randomly assigned to one of two treatment groups for intraoperative treatment of their mastectomy wound before it is closed.
The first group will consist of those who will be treated with the intravenous form of TXA that will be applied to the surface of the mastectomy wound area rather than being injected into a vein. The second group consists of those individuals who will be treated with a topical normal saline solution (a placebo, or inactive substance that looks identical to the study drug but contains no therapeutic ingredients).
Both groups will receive the same number of drains and the same post-operative follow-up schedule consisting of visits 2 to 4 weeks and 3 months after the surgery, as well as a last 12 months follow-up. Standard of care will be practiced with respect to all procedures and visits.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 100 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Hamilton Health Sciences Corporation is the lead sponsor of 242 studies on the registry; 38 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Tranexamic Acid 100mg/mL, 20mL topical
Drug: Normal Saline Flush, 0.9%, 20mL topical
Drug page: Tranexamic Acid
Drug: Tranexamic Acid 20 mL TXA (100 mg/mL injection solution, total 2g TXA) applied topically to the mastectomy cavity for 5 minutes before wound closure
Drug: Normal Saline 20 mL 0.9% NaCl (normal saline) applied topically to the mastectomy cavity for 5 minutes before wound closure
Recruitment rate
Number of patients recruited over the total number of eligible patients screened
Time frame: About 6 months
Randomization rate
Number of patients randomized over total number recruited
Time frame: About 9 months
Follow-up visit rate
Number of patients with successful follow-up visits at 3 weeks and 3 months
Time frame: 3 months
Ability to adhere to protocol
Number of patients randomized to TXA who received TXA vs number of patients randomized to placebo who received the placebo
Time frame: About 12 months
Seroma rate
Rate of seroma formation within 3 months following mastectomy in each arm of the study.
Time frame: 3 months
Seroma volume
Amount of drainage (volume) in patients who did have a seroma, for patients in both arms of the study
Time frame: 3 months
Seroma aspiration
Aspirated volume in patients who did have a seroma, for patients in both arms of the study
Time frame: 3 months
Delay in adjuvant treatment
Time (number of weeks) of delay in adjuvant treatment due to seroma/hematoma complication, for patients in both arms of the study
Time frame: 3 months
Other complications rate: Hematoma rate
Rate of hematoma within 3 months following mastectomy in each arm of the study
Time frame: 3 months
Other complications rate: Infection rate
Rate of infection within 3 months following mastectomy in each arm of the study
Time frame: 3 months
Other complications rate: Wound dehiscence rate
Rate of wound dehiscence within 3 months following mastectomy in each arm of the study
Time frame: 3 months
Daily output volume
Daily drain output (volume), in patients in both arms of the study
Time frame: 3 months
Drain discontinuation
Time to drain discontinuation (number of days) in patients in both arms of the study
Time frame: 3 months
Drain complications
Presence of drain complications (leakage, dislodgement, blockage), in patients in both arms of the study
Time frame: 3 months
Safety outcomes: rate of thromboembolic events
Rate of Thromboembolic events within 3 weeks following mastectomy, in patients in both arms of the study
Time frame: 3 weeks
Safety outcomes: rate of myocardial events
Rate of myocardial events within 3 weeks following mastectomy, in patients in both arms of the study • Rate of other adverse events within 3 weeks following mastectomy
Time frame: 3 weeks
Safety outcomes: rate of other adverse events
Rate of other adverse events within 3 weeks following mastectomy, in patients in both arms of the study
Time frame: 3 weeks
Plan to share: No
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Studies of the drug tested here: Tranexamic Acid
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