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Hematoma PostoperativePhase 3NCT04918589

Tranexamic Acid for Alloplastic Breast Reconstruction

A Phase 3 study testing Tranexamic acid and Normal Saline in people with Hematoma Postoperative and Breast Cancer, run by McMaster University at 3 sites in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Hematoma is a common complication of alloplastic breast reconstruction. This can lead to pain and discomfort experienced by the patient, in addition to greater use of valuable healthcare resources. Read more about this study

Who is it for?
Ages 18 to 99 years, women only
What is being tested?
Tranexamic acid and Normal Saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
106 participants
Where
3 sitesCanada
Study dates
Aug 2022to Aug 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Are 18 years or older;
  • Are undergoing one- or two-stage bilateral alloplastic breast reconstruction immediately after bilateral mastectomy at either Hamilton Health Sciences or St. Joseph's Hospital Hamilton.

Who cannot join

  • Taking therapeutic anticoagulation;
  • Taking antiplatelet drugs;
  • Pregnant or breast feeding;
  • Allergic to TXA;
  • Cannot provide informed consent;
  • Alloplastic reconstruction is not performed immediately after mastectomy;
  • Have a documented coagulopathy or bleeding disorder, acquired disturbances of colour vision, subarachnoid hemorrhage, hematuria, irregular menstrual bleeding, or seizure disorder.

Trial locations and contacts

3 sites in 1 country.

Minh Huynh, MD contact

9055221155

minh.huynh@medportal.ca

Canada3 sites

  • St. Joseph's Healthcare, King Campus

    Hamilton, Ontario, L8G 5E4

    Mark McRae, MD, FRCSC

  • St. Joseph's Healthcare, Charlton Campus

    Hamilton, Ontario, L8N 4A6

    Sophoceles Voineskos, MD, FRCSC

  • Juravinski Hospital, Hamilton Health Sciences

    Hamilton, Ontario, L8V 1C3

    Ronen Avram, MD, FRCSC

Other trials in Canada

About this study

Official title: Effects of Tranexamic Acid for Alloplastic Breast Reconstruction: A Randomized Control Trial

Hematoma is a common complication of alloplastic breast reconstruction. This can lead to pain and discomfort experienced by the patient, in addition to greater use of valuable healthcare resources. Previous studies have shown correlation between the use of tranexamic acid (TXA), an anti-fibrinolytic, and reduced post-surgical bleeding complication events.

In this randomized control trial (RCT) assessing TXA use in alloplastic breast reconstruction, one breast will be randomized to have TXA applied topically, while the other will have normal saline (NS) placebo applied. The primary objective of this prospective blinded randomized control trial study is to determine if the administration of topical TXA in alloplastic breast reconstruction reduces the incidence of surgical site hematoma compared to placebo within 2 weeks following surgery. The results of this study will be used to inform the design of a larger multicentered RCT on TXA in breast surgery.

Read the detailed description

The primary objective of this study is to investigate the use of topical application of tranexamic Acid (TXA) to the surgical wound as a means to decrease hematoma formation compared to placebo in patients undergoing alloplastic breast reconstruction. This project is designed as a single-center RCT to evaluate the effectiveness of topical TXA in this patient population.

If enrolled in this study, patients individual breasts will be randomly assigned to one of two treatment groups for to apply to the wound before it is closed.

One breast will have an intravenous form of TXA applied topically to the surgical site. The other will be have a topical normal saline solution applied to the wound before closure (a placebo).

The patients will have the standard number of drains and postoperative instructions for breast reconstruction. They will follow-up at two weeks time in clinic for assessment, and emergency room visits will be also be evaluated. Standard of care will be practiced with respect to all procedures and visits.

Being tested
Tranexamic acid, Normal Saline
Keywords
Alloplastic Breast Reconstruction
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tranexamic acidDrug

    Also called TXA

    3 grams of tranexamic acid (30 mL of 100 mg/mL solution) diluted in 10 mL of normal saline

  • Normal SalineDrug

    Also called NS

    40 mL topical of 0.9% normal saline

Study groups in NCT04918589
Study groupRoleWhat they receive
Tranexamic AcidExperimental3 grams of tranexamic acid (30 mL of 100 mg/mL solution) diluted in 10 mL of normal saline
Receives: Drug: Tranexamic acid
Normal SalinePlacebo comparator40 mL topical of 0.9% normal saline
Receives: Drug: Normal Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hematoma

    Incidence rate of hematoma

    Measured: 2 weeks

  2. Seroma

    Incidence rate of seroma

    Measured: 2 weeks

Secondary outcomes (5)

  1. Drain output

    Total drain output (mL) at 24 hours

    Measured: 24 hours

  2. Days with drains

    Total number of days drains in situ with standard discharge criteria

    Measured: 2 weeks

  3. Reoperation rate

    Number of repeat operations required for patient related to complication

    Measured: 2 weeks

  4. Reintervention rate

    Rate of subsequent interventions including aspiration, repeat drain insertion or other

    Measured: 2 weeks

  5. Imaging findings

    Ultrasound findings of hematoma or seroma, if applicable

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2021
  2. Study startAug 2022 (estimated)
  3. Primary completionAug 2024 (estimated)
  4. Study completionAug 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Controlled Trial (RCT) with 2 arms: the interventional arm (receiving topical TXA) and the control arm (receiving placebo). Intervention: Topical application of 3 grams of tranexamic acid (30 mL of 100 mg/mL) diluted in 10 mL of normal saline in the breast. Placebo: Topical application of 40 mL of 0.9% normal saline to the breast.
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
106 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04918589
Sponsor's protocol ID
13104
Status last verified
Apr 2022
First submitted
4 Jun 2021
Last updated
6 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ker K, Edwards P, Perel P, Shakur H, Roberts I. Effect of tranexamic acid on surgical bleeding: systematic review and cumulative meta-analysis. BMJ. 2012 May 17;344:e3054. doi: 10.1136/bmj.e3054.

    PubMed 22611164

  • Wong J, Abrishami A, El Beheiry H, Mahomed NN, Roderick Davey J, Gandhi R, Syed KA, Muhammad Ovais Hasan S, De Silva Y, Chung F. Topical application of tranexamic acid reduces postoperative blood loss in total knee arthroplasty: a randomized, controlled trial. J Bone Joint Surg Am. 2010 Nov 3;92(15):2503-13. doi: 10.2106/JBJS.I.01518.

    PubMed 21048170

  • De Bonis M, Cavaliere F, Alessandrini F, Lapenna E, Santarelli F, Moscato U, Schiavello R, Possati GF. Topical use of tranexamic acid in coronary artery bypass operations: a double-blind, prospective, randomized, placebo-controlled study. J Thorac Cardiovasc Surg. 2000 Mar;119(3):575-80. doi: 10.1016/s0022-5223(00)70139-5.

    PubMed 10694619

  • Ipema HJ, Tanzi MG. Use of topical tranexamic acid or aminocaproic acid to prevent bleeding after major surgical procedures. Ann Pharmacother. 2012 Jan;46(1):97-107. doi: 10.1345/aph.1Q383. Epub 2011 Dec 27.

    PubMed 22202494

  • Gomez-Barrena E, Ortega-Andreu M, Padilla-Eguiluz NG, Perez-Chrzanowska H, Figueredo-Zalve R. Topical intra-articular compared with intravenous tranexamic acid to reduce blood loss in primary total knee replacement: a double-blind, randomized, controlled, noninferiority clinical trial. J Bone Joint Surg Am. 2014 Dec 3;96(23):1937-44. doi: 10.2106/JBJS.N.00060.

    PubMed 25471907

  • Wind TC, Barfield WR, Moskal JT. The effect of tranexamic acid on blood loss and transfusion rate in primary total knee arthroplasty. J Arthroplasty. 2013 Aug;28(7):1080-3. doi: 10.1016/j.arth.2012.11.016. Epub 2013 Mar 28.

    PubMed 23541868

  • Wang H, Shen B, Zeng Y. Comparison of topical versus intravenous tranexamic acid in primary total knee arthroplasty: a meta-analysis of randomized controlled and prospective cohort trials. Knee. 2014 Dec;21(6):987-93. doi: 10.1016/j.knee.2014.09.010. Epub 2014 Oct 23.

    PubMed 25450009

  • Knight H, Banks J, Muchmore J, Ives C, Green M. Examining the use of intraoperative tranexamic acid in oncoplastic breast surgery. Breast J. 2019 Sep;25(5):1047-1049. doi: 10.1111/tbj.13409. Epub 2019 Jun 11. No abstract available.

    PubMed 31187540

  • Pinsolle V, Grinfeder C, Mathoulin-Pelissier S, Faucher A. Complications analysis of 266 immediate breast reconstructions. J Plast Reconstr Aesthet Surg. 2006;59(10):1017-24. doi: 10.1016/j.bjps.2006.03.057. Epub 2006 Jun 5.

    PubMed 16996422

  • Nelson JA, Fischer JP, Grover R, Cleveland E, Erdmann-Sager J, Serletti JM, Wu LC. The impact of anemia on microsurgical breast reconstruction complications and outcomes. Microsurgery. 2014 May;34(4):261-70. doi: 10.1002/micr.22202. Epub 2013 Nov 4.

    PubMed 24436188

  • Megson M. Traumatic subcutaneous haematoma causing skin necrosis. BMJ Case Rep. 2011 Jul 20;2011:bcr0520114273. doi: 10.1136/bcr.05.2011.4273.

    PubMed 22689664

  • Rogoff H, Marquez JE, Ghosh K, Jou C, McAuliffe P, Rathi S, Monroig K, Medrano C, Marmor WA, Ferrier A, Kapadia K, Klein G, Huston TL, Ganz J, Dagum AB, Khan S, Bui D. Clinical Outcomes After Hematoma Development: A Study of 627 Tissue Expander Breast Reconstructions. Ann Plast Surg. 2020 Jul;85(S1 Suppl 1):S63-S67. doi: 10.1097/SAP.0000000000002343.

    PubMed 32243320

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tranexamic acid and Normal Saline in people with Hematoma Postoperative and Breast Cancer, run by McMaster University at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Minh Huynh, MD (9055221155, minh.huynh@medportal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hematoma (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04918589, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.

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