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

• Norway
  • Trondheim, Norway, 7006
    • Recruiting
    • St Olav's University Hospital

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. Insufficient knowledge of national language or English.

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	• Comparison between wounds receiving TXA versus placebo of the incidence of postoperative re-bleeding within the first postoperative 10 days	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative wound infection	• Comparison between wounds receiving TXA versus placebo of the incidence of postoperative wound infection within the first 30 days requiring any of the following: Extra outpatient follow-up, re-operation, or revision or antibiotic treatment.	30 days
Postoperative wound rupture	• Comparison between wounds receiving TXA versus placebo of the incidence of wound rupture within the first 30 days requiring any of the following: Extra outpatient follow-up, re-operation, or revision.	30 days
Postoperative thromboembolic events	• Comparison between wounds receiving TXA versus placebo of the incidence of • thromboembolic events defined as thrombophlebitis, deep venous thrombosis, pulmonary embolus, cerebral or coronary infarctions until 30 days postoperatively	30 days
Postoperative seroma	• Comparison between wounds receiving TXA versus placebo of the incidence of • seroma defined as the need for aspiration of fluids, or spontaneous evacuation of voluminous fluids, between 10 and 30 days postoperatively	Between day 10 and 30
Any other postoperative complication	• Comparison between wounds receiving TXA versus placebo of the incidence of • other possible adverse effects causing contact with the health service until 30 days postoperatively.	30 days

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Collaborators: Helsinki University Central Hospital; University Hospital of North Norway; Helse Stavanger HF; Haukeland University Hospital; Sykehuset Innlandet HF; Sykehuset Telemark; Molde Hospital; Haraldsplass Deaconess Hospital; Sykehuset Asker og Baerum; Smerud Medical Research International AS; Oslo universitetssykehus HF; Bodø sykehus
• Investigators: Principal Investigator: Kjersti Ausen, MD PhD, St Olav's University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 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 (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: December 2, 2024
• Last Verified: December 1, 2024

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; Molecular Mechanisms of Pharmacological Action; Antifibrinolytic Agents; Fibrin Modulating Agents; Hemostatics; Coagulants; Tranexamic Acid
• 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)?: YES
• IPD Plan Description: Anonymized individual participant data can be made available upon reasonable request.
• 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