The Effect of Local Application of Tranexamic Acid Versus Placebo on Postoperative Complications in Plastic Surgery (TRANOP)

The Effect of Topical Tranexamic Acid on Postoperative Complications in Soft Tissue Plastic Surgery - A Multicenter Randomized Controlled Trial

Study objective:

This is a study to investigate whether applying the drug tranexamic acid (TXA) onto a surgical wound surface may affect the incidence of surgical complications such as re-bleeding needing intervention, wound complications such as infection, wound rupture or seroma, or if it may increase the risk of blood clots.

Eligible patients:

Patients undergoing plastic surgical procedures with wounds that would normally receive application of TXA to reduce bleeding after surgery.

Study intervention:

Participants will receive a single local application of study drug onto their wound surfaces at the end of surgery. Study drug will be identical looking ampoules which contain either TXA or placebo (saline). Neither participants nor study personnel will know the contents of the ampoules.

Study Overview

• Status: Recruiting
• Conditions: Surgical Complication
• Intervention / Treatment: Drug: Tranexamic Acid 100 MG/ML; Drug: 0.9%sodium chloride

Detailed Description

Any serious postoperative complication needing intervention, specifically re-bleeding, wound infection, wound rupture, or the occurrence of blood clots for the first 30 days after surgery will be registered through the following interventions:

• Screening of patient medical records
• Distribution of an electronic self-report form (eForsk®) to participating patients at postoperative day 30
• Follow-up phone call to verify data after day 30.

The study is terminated after the final phone call. All study data will be registered in an electronic, pseudonymous web-based registration form (eCRF/Viedoc®).

Number of participants: To assess the effect of TXA on the defined surgical complications compared to placebo, 1500 patients are needed in each group.

Data monitoring committee:

A data monitoring committee consisting of a group of independent scientists will be appointed for this study to monitor the safety and scientific integrity of this human research intervention.

• Study Type: Interventional
• Enrollment (Estimated): 3000
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kjersti Ausen, MD PhD; Phone Number: +4792249693; Email: kjerstiausen@gmail.com
• Study Contact Backup: Name: Olav Spigset, MD PhD; Phone Number: +47 936 64 337; Email: olav.spigset@legemidler.no

Study Locations

• Denmark
  • Vejle, Denmark, 7100
    • Recruiting
    • Vejle Sykehus
    • Contact: Tine E Damsgaard, MD PhD; Phone Number: +45 40436377; Email: Tine.M.Engberg.Damsgaard@rsyd.dk
    • Contact: Bekka O Christensen, MD PhD; Phone Number: +45 22588797; Email: bekka.christensen@rsyd.dk
• Finland
  • Helsinki, Finland, 00029
    • Recruiting
    • Helsinki University Hospital HUS
    • Contact: Susanna Kauhanen, MD PhD; Phone Number: +358 405486186; Email: susanna.kauhanen@hus.fi
    • Contact: Krisztina Sipos, MD; Phone Number: +358 405355301; Email: krisztina.sipos@hus.fi
• Norway
  • Bergen, Norway, 5009
    • Recruiting
    • Haraldsplass Diakonale Sykehus
    • Contact: Hildur Skuladottir, MD PhD; Phone Number: +47 93643809; Email: hildur.skuladottir@haraldsplass.no
    • Contact: Thale Riisøen, MD; Phone Number: +47 45247204; Email: thale.gjessing.uchermann.riisoen@haraldsplass.no
  • Gjettum, Norway, 1346
    • Recruiting
    • Bærum sykehus
    • Contact: Ane B Opheim, MD; Phone Number: +47 95914412; Email: ane_kbo@hotmail.com
    • Contact: Agnieszka M Zwaan, MD; Phone Number: +47 41105687; Email: agazwaan@icloud.com
  • Hamar, Norway, 2318
    • Not yet recruiting
    • Sykehuset Innlandet Hamar
    • Contact: Lene Oskal, MD; Phone Number: +47 92040372; Email: lene.oskal2@sykehuset-innlandet.no
    • Contact: Neda Nicodemus, MD; Phone Number: +47 41494563; Email: neda.nicodemus@sykehuset-innlandet.no
  • Hjelset, Norway, 6450
    • Recruiting
    • Sykehuset Nordmøre og Romsdal
    • Contact: Christian Busch, MD PhD; Phone Number: +47 93069602; Email: christian.busch@helse-mr.no
    • Contact: Anny K Rønning, MD; Phone Number: +47 99697901; Email: Anny.Katharina.Ronning@helse-mr.no
  • Oslo, Norway, 0372
    • Recruiting
    • Oslo Universitetssykehus Rikshospitalet
    • Contact: Ane B Opheim, MD; Phone Number: +47 95914412; Email: ane_kbo@hotmail.com
    • Contact: Kim Tønsett, Professor MD PhD; Phone Number: +47 91823436; Email: ktonseth@ous-hf.no
  • Stavanger, Norway, 4017
    • Not yet recruiting
    • Stavanger Universitetssykehus SUS
    • Contact: Kristin O Furholt, MD; Phone Number: +47 97600959; Email: kristin.ochoa.furholt@sus.no
    • Contact: Elisabeth Zetlitz, MD; Phone Number: +47 48603378; Email: elisabeth.zetlitz@sus.no
  • Tromsø, Norway, 9019
    • Recruiting
    • UNN Tromsø
    • Contact: Thomas K Sjøberg, MD PhD; Phone Number: +47 46433789; Email: thomas.sjoberg@unn.no
    • Contact: Tarald Rekve, MD; Phone Number: +47 90941352; Email: tarald.rekve@unn.no
  • Trondheim, Norway, 7006
    • Recruiting
    • St Olav's University Hospital
  • Tynset, Norway, 2500
    • Recruiting
    • Sykehuset Innlandet Tynset
    • Contact: Gudjon Gunnarson, MD; Phone Number: +47 92225142; Email: gudjonleifur@yahoo.com
    • Contact: Grethe Holøymoen, Study Nurse; Phone Number: +47 48137598; Email: grethe.holoymoen@sykehuset-innlandet.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients are eligible to be included in the study only if all of the following criteria apply:

  1. They are to undergo a surgical procedure within the field of plastic surgery where the procedure involves use of topical TXA at the participating center.
  2. They are over 18 years of age and capable of independently providing informed consent
  3. They have received adequate oral and written information about the study and signed the informed-consent form

Exclusion Criteria:

• Patients with known allergy to tranexamic acid.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tranexamic acid arm; Anonymous ampoule containing 5 ml of 100 mg/ml Tranexamic Acid. If surgeon wants to apply tranexamic acid onto the wound surface, the study ampoule will be diluted and applied in accordance with the surgeon's practice when using Tranexamic Acid.	Drug: Tranexamic Acid 100 MG/ML; If surgeon wants to apply tranexamic acid onto the wound surface, the study ampoule will be diluted and applied in accordance with the surgeon's practice when using tranexamic acid; Other Names: Saline (placebo)
Placebo Comparator: Placebo arm; Anonymous ampoule containing 5 ml of 0.9% NaCl. If surgeon wants to apply tranexamic acid onto the wound surface, the study ampoule will be diluted and applied in accordance with the surgeon's practice when using Tranexamic Acid.	Drug: 0.9%sodium chloride; If surgeon wants to apply tranexamic acid onto the wound surface, the study ampoule will be diluted and applied in accordance with the surgeon's practice when using Tranexamic Acid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative re-bleeding	The primary objective is to demonstrate that topical application of TXA is superior to placebo (saline) in preventing postoperative bleeding needing intervention within the first 10 days after surgery. Thus, the null hypothesis to be tested in relation to the primary estimand is as follows:; Null hypothesis: Re-bleeding needing intervention, defined as the dicotome variable occurrence or absence of one of more of the below defined events within the first 10 postoperative days, occurs with the same incidence in wounds treated with topical TXA versus topical placebo (saline). One or several of the following will qualify as case:Re-operationsurgical exploration or evacuationaspiration of hematomablood transfusionexternal extra compression due to hematoma; Alternative hypothesis: Re-bleeding as defined above occurs less often with TXA than placebo (saline)	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative wound infection	Null hypothesis: Wound infection needing intervention, defined as the dicotome variable occurrence or absence of one of more of the below defined events with within the first 30 postoperative days, occurs with the same incidence in wounds treated with topical TXA versus topical placebo (saline). One or several of the following will qualify as a case:Extra outpatient follow-upRe-operation or surgical revisionAntibiotic treatment.; Alternative hypothesis: Wound infection as defined above occurs more often with TXA than placebo (saline)	30 days
Postoperative wound rupture	Null hypothesis: Wound rupture needing intervention, defined as the dicotome variable occurrence or absence of one of more of the below defined events with within the first 30 postoperative days, occurs with the same incidence in wounds treated with topical TXA versus topical placebo (saline). One or several of the following will qualify as a case:Extra outpatient follow-upRe-operation or surgical revision; Alternative hypothesis: Wound rupture as defined above occurs more often with TXA than placebo (saline)	30 days
Postoperative seroma	Null hypothesis: Seroma needing intervention, defined as the dicotome variable occurrence or absence of one of more of the below defined events with within the first 30 postoperative days, occurs with the same incidence in wounds treated with topical TXA versus topical placebo (saline). One or several of the following will qualify as a case:Active aspiration of seromaPassive spontaneous drainage of a significant volume of seroma; Alternative hypothesis: Seroma as defined above occurs more often with TXA than placebo (saline)	30 days
Postoperative thromboembolic events	Null hypothesis: Postoperative thromboembolic events, defined as the dicotome variable occurrence or absence of one of more of the below defined events with within the first 30 postoperative days, occurs with the same incidence in wounds treated with topical TXA versus topical placebo (saline). One or several of the following will qualify as a case:Deep venous thrombosisPulmonary embolusCerebral or coronary infarction; Alternative hypothesis: Thromboembolic events as defined above occurs more often with TXA than placebo (saline)	30 days
Other possible adverse effects	Other possible adverse effects causing contact with the health service until 30 days postoperatively	30 days

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Collaborators: Oslo University Hospital; Helsinki University Central Hospital; University Hospital of North Norway; Helse Stavanger HF; Vejle Hospital; Haraldsplass Deaconess Hospital; Smerud Medical Research International AS; Bærum sykehus; Sykehuset SNR; Hamar sykehus; Tynset Sykehus
• Investigators: Principal Investigator: Kjersti Ausen, MD PhD, St Olav's University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: February 13, 2024
• First Posted (Actual): February 21, 2024

Study Record Updates

• Last Update Posted (Actual): August 14, 2026
• Last Update Submitted That Met QC Criteria: August 11, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: tranexamic acid postoperative bleeding infection wound rupture seroma thromboembolism
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Organic Chemicals; Carboxylic Acids; Inorganic Chemicals; Chlorine Compounds; Acids, Carbocyclic; Cyclohexanecarboxylic Acids; Sodium Compounds; Chlorides; Hydrochloric Acid; Tranexamic Acid; Sodium Chloride
• Other Study ID Numbers: 270777; 2022-001580-28 (EudraCT Number); 2023-510381-28-01 (Registry Identifier: CTIS European Clinical Trial Identification System)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan at the moment to share the IPD. Datasets will be kept available in secure digital storage for at least 25 years. Access to analyzable datasets through a secure system may be granted following an independent assessment of the scientific merit of a defined research question from a third party.
• IPD Sharing Time Frame: Data will become available after the completion and publication of the study and will remain available upon reasonable request. Data will be stored for 25 years.
• IPD Sharing Access Criteria: First or last author must be contacted with a detailed description of what data is needed for. Whether data will be shared must be determined by the investigators and possibly by the regional ethic committee.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No