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Antifibrinolytic agent

Tranexamic Acid 100mg/mL, 20mL topical for Hematoma (SEROMA Trial)

Phase 4
Waitlist Available
Led By Nicole Hodgson, MD, MSc, FRCSC
Research Sponsored by Hamilton Health Sciences Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up about 12 months
Awards & highlights

SEROMA Trial Summary

This study is evaluating whether a topical application of TXA can reduce the rate of post-operative hematomas and seromas in breast cancer patients after their mastectomy.

Eligible Conditions
  • Hematoma
  • Seroma
  • Breast Cancer

SEROMA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~about 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and about 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ability to adhere to protocol
Follow-up visit rate
Randomization rate
+1 more
Secondary outcome measures
Delay in adjuvant treatment
Seroma aspiration
Seroma rate
+1 more
Other outcome measures
Daily output volume
Drain complications
Drain discontinuation
+6 more

Side effects data

From 2017 Phase 4 trial • 246 Patients • NCT02030821
2%
Hematoma/Seroma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Epsilon-aminocaproic Acid (Amicar) - Total Hip Arthroplasty
Epsilon-aminocaproic Acid (Amicar) - Total Knee Arthroplasty
Tranexamic Acid (TXA) - Total Hip Arthroplasty
Tranexamic Acid (TXA) - Total Knee Arthroplasty

SEROMA Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TXA armExperimental Treatment1 Intervention
Group II: Placebo armPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Hamilton Health Sciences CorporationLead Sponsor
368 Previous Clinical Trials
300,901 Total Patients Enrolled
2 Trials studying Hematoma
526 Patients Enrolled for Hematoma
Nicole Hodgson, MD, MSc, FRCSCPrincipal InvestigatorHamilton Health Sciences, McMaster University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
British Journal of SurgeryJournal
Randomized Clinical Trial of Topical Tranexamic Acid After Reduction Mammoplasty
Ausen, K, R Fossmark, O Spigset, and H Pleym. 2015. “Randomized Clinical Trial of Topical Tranexamic Acid After Reduction Mammoplasty”. British Journal of Surgery. Oxford University Press (OUP). doi:10.1002/bjs.9878.
Cochrane Database of Systematic ReviewsJournal
Topical Application of Tranexamic Acid for the Reduction of Bleeding
Ker, Katharine, Deirdre Beecher, and Ian Roberts. 2013. “Topical Application of Tranexamic Acid for the Reduction of Bleeding”. Edited by Katharine Ker. Cochrane Database of Systematic Reviews. John Wiley & Sons, Ltd. doi:10.1002/14651858.cd010562.
British Journal of SurgeryJournal
Randomized Clinical Trial of Topical Tranexamic Acid After Reduction Mammoplasty
Ausen, K, R Fossmark, O Spigset, and H Pleym. 2015. “Randomized Clinical Trial of Topical Tranexamic Acid After Reduction Mammoplasty”. British Journal of Surgery. Oxford University Press (OUP). doi:10.1002/bjs.9878.
Cochrane Database of Systematic ReviewsJournal
Topical Application of Tranexamic Acid for the Reduction of Bleeding
Ker, Katharine, Deirdre Beecher, and Ian Roberts. 2013. “Topical Application of Tranexamic Acid for the Reduction of Bleeding”. Edited by Katharine Ker. Cochrane Database of Systematic Reviews. John Wiley & Sons, Ltd. doi:10.1002/14651858.cd010562.
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