Surgical ComplicationPhase 4TRANOPNCT06270407
The Effect of Local Application of Tranexamic Acid Versus Placebo on Postoperative Complications in Plastic Surgery
A Phase 4 study testing Tranexamic Acid 100 MG/ML and 0.9%sodium chloride in people with Surgical Complication, run by St. Olavs Hospital at 11 sites in 3 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Complication
- What is being tested?
- Tranexamic Acid 100 MG/ML and 0.9%sodium chloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,000 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 18 Sep 2024to 31 Dec 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are eligible to be included in the study only if all of the following criteria apply:
- 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.
- They are over 18 years of age and capable of independently providing informed consent
- They have received adequate oral and written information about the study and signed the informed-consent form
Who cannot join
- Patients with known allergy to tranexamic acid.
Trial locations and contacts
11 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 3 countries
Norway9 sites, 9 recruiting
- Recruiting
Haraldsplass Diakonale Sykehus
Bergen, 5009
Hildur Skuladottir, MD PhD, +47 93643809, hildur.skuladottir@haraldsplass.no
Thale Riisøen, MD, +47 45247204, thale.gjessing.uchermann.riisoen@haraldsplass.no
- Recruiting
Bærum Sykehus
Gjettum, 1346
Ane B Opheim, MD, +47 95914412, ane_kbo@hotmail.com
Agnieszka M Zwaan, MD, +47 41105687, agazwaan@icloud.com
- Not yet recruiting
Sykehuset Innlandet Hamar
Hamar, 2318
Lene Oskal, MD, +47 92040372, lene.oskal2@sykehuset-innlandet.no
Neda Nicodemus, MD, +47 41494563, neda.nicodemus@sykehuset-innlandet.no
- Recruiting
Sykehuset Nordmøre og Romsdal
Hjelset, 6450
Christian Busch, MD PhD, +47 93069602, christian.busch@helse-mr.no
Anny K Rønning, MD, +47 99697901, Anny.Katharina.Ronning@helse-mr.no
- Recruiting
Oslo Universitetssykehus Rikshospitalet
Oslo, 0372
Ane B Opheim, MD, +47 95914412, ane_kbo@hotmail.com
Kim Tønsett, Professor MD PhD, +47 91823436, ktonseth@ous-hf.no
- Not yet recruiting
Stavanger Universitetssykehus SUS
Stavanger, 4017
Kristin O Furholt, MD, +47 97600959, kristin.ochoa.furholt@sus.no
Elisabeth Zetlitz, MD, +47 48603378, elisabeth.zetlitz@sus.no
- Recruiting
UNN Tromsø
Tromsø, 9019
Thomas K Sjøberg, MD PhD, +47 46433789, thomas.sjoberg@unn.no
Tarald Rekve, MD, +47 90941352, tarald.rekve@unn.no
- Recruiting
St Olav's University Hospital
Trondheim, 7006
- Recruiting
Sykehuset Innlandet Tynset
Tynset, 2500
Gudjon Gunnarson, MD, +47 92225142, gudjonleifur@yahoo.com
Grethe Holøymoen, Study Nurse, +47 48137598, grethe.holoymoen@sykehuset-innlandet.no
Denmark1 site, 1 recruiting
- Recruiting
Vejle Sykehus
Vejle, 7100
Tine E Damsgaard, MD PhD, +45 40436377, Tine.M.Engberg.Damsgaard@rsyd.dk
Bekka O Christensen, MD PhD, +45 22588797, bekka.christensen@rsyd.dk
Finland1 site, 1 recruiting
- Recruiting
Helsinki University Hospital HUS
Helsinki, 00029
Susanna Kauhanen, MD PhD, +358 405486186, susanna.kauhanen@hus.fi
Krisztina Sipos, MD, +358 405355301, krisztina.sipos@hus.fi
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Surgical Complication
- Being tested
- Tranexamic Acid 100 MG/ML, 0.9%sodium chloride
- Keywords
- tranexamic acid postoperative bleeding infection wound rupture seroma thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid 100 MG/MLDrug
Also called 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
0.9%sodium chlorideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid arm | Active comparator | 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. Receives: Drug: Tranexamic Acid 100 MG/ML |
| Placebo arm | Placebo comparator | 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. Receives: Drug: 0.9%sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 10 days
Secondary outcomes (5)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 30 days
Other possible adverse effects
Other possible adverse effects causing contact with the health service until 30 days postoperatively
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start18 Sep 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical ComplicationStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled prospective interventional trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Smerud Medical Research International AS, Oslo University Hospital, Haraldsplass Deaconess Hospital, Helse Stavanger HF, University Hospital of North Norway, Helsinki University Central Hospital, Vejle Hospital, Bærum sykehus, Sykehuset SNR, Hamar sykehus, Tynset Sykehus
- Responsible party
- Sponsor
- Investigators
- Kjersti Ausen, MD PhD, Principal investigator, St Olav's University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270407
- Sponsor's protocol ID
- 270777
- Other IDs
- 2022-001580-28, 2023-510381-28-01, 2023
- Acronym
- TRANOP
- Status last verified
- Aug 2026
- First submitted
- 13 Feb 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Topical Tranexamic Acid on Postoperative Complications in Soft Tissue Plastic Surgery - A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06270407
- Acronym / sponsor ID
- TRANOP / 270777
- Conditions
- Surgical Complication
- Keywords
- tranexamic acid postoperative bleeding infection wound rupture seroma thromboembolism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Smerud Medical Research International AS, Oslo University Hospital, Haraldsplass Deaconess Hospital, Helse Stavanger HF, University Hospital of North Norway, Helsinki University Central Hospital, Vejle Hospital, Bærum sykehus, Sykehuset SNR, Hamar sykehus, Tynset Sykehus
- Study start
- 18 Sep 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled prospective interventional trial
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid arm | Active comparator | Drug: Tranexamic Acid 100 MG/MLAnonymous 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. |
| Placebo arm | Placebo comparator | Drug: 0.9%sodium chlorideAnonymous 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients are eligible to be included in the study only if all of the following criteria apply:
Key exclusion criteria (1 listed)
- Patients with known allergy to tranexamic acid.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic Acid 100 MG/MLAlso: 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 | Drug | Tranexamic acid arm |
| 0.9%sodium chlorideIf 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 | Placebo arm |
Primary outcome
Postoperative re-bleeding
Time frame: 10 days
* 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)
5 secondary outcomes
Postoperative wound infection
Time frame: 30 days
Postoperative wound rupture
Time frame: 30 days
Postoperative seroma
Time frame: 30 days
Postoperative thromboembolic events
Time frame: 30 days
Other possible adverse effects
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kjersti Ausen, MD PhD principal investigator
St Olav's University Hospital
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic Acid 100 MG/ML and 0.9%sodium chloride in people with Surgical Complication, run by St. Olavs Hospital at 11 sites in 3 countries.
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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Norway, Denmark, Finland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kjersti Ausen, MD PhD (+4792249693, kjerstiausen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative re-bleeding (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2026.