A Phase 4 interventional study of Tranexamic Acid 100 MG/ML and 0.9%sodium chloride in Surgical Complication, sponsored by St. Olavs Hospital. Recruiting at 11 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by St. Olavs Hospital · Phase 4, Interventional, and Prevention
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.
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:
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.
St. Olavs Hospital is the lead sponsor of 171 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients are eligible to be included in the study only if all of the following criteria apply:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Drug page: 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
Also known as: Saline (placebo)
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.
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-operation * surgical exploration or evacuation * aspiration of hematoma * blood transfusion * external extra compression due to hematoma * Alternative hypothesis: Re-bleeding as defined above occurs less often with TXA than placebo (saline)
Time frame: 10 days
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-up * Re-operation or surgical revision * Antibiotic treatment. * Alternative hypothesis: Wound infection as defined above occurs more often with TXA than placebo (saline)
Time frame: 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-up * Re-operation or surgical revision * Alternative hypothesis: Wound rupture as defined above occurs more often with TXA than placebo (saline)
Time frame: 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 seroma * Passive spontaneous drainage of a significant volume of seroma * Alternative hypothesis: Seroma as defined above occurs more often with TXA than placebo (saline)
Time frame: 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 thrombosis * Pulmonary embolus * Cerebral or coronary infarction * Alternative hypothesis: Thromboembolic events as defined above occurs more often with TXA than placebo (saline)
Time frame: 30 days
Other possible adverse effects
Other possible adverse effects causing contact with the health service until 30 days postoperatively
Time frame: 30 days
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — 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.
Started Sep 2024 (actual). Primary completion is estimated for Dec 2028, 51 months after the start.
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Studies of the drug tested here: Tranexamic Acid