Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
3,500
Countries
3
Sites
14
Patients undergoing plastic surgical procedures with wounds that would normally receive application of TXA to reduce bleeding after surgery.
The main objective is to investigate whether topical use of TXA onto a surgical wound surface affects the incidence of postoperative re-bleeding needing intervention within 10 days after surgery.
Key facts
- Sponsor
- St. Olavs Hospital HF
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]
- Trial duration
- 18 Sep 2024 → ongoing
- Decision date (initial)
- 2025-09-14
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-510381-28-01
- EudraCT number
- 2022-001580-28
- ClinicalTrials.gov
- NCT06270407
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Prophylaxis, Safety, Therapy
The main objective is to investigate whether topical use of TXA onto a surgical wound surface affects the incidence of postoperative re-bleeding needing intervention within 10 days after surgery.
Secondary objectives 1
- Secondary objectives are to investigate whether the procedure affects the incidence of wound infection, wound rupture, postoperative seroma or thromboembolic events needing intervention within 30 days after surgery. Estimands are the occurrence or absence of such incidents within the defined time periods.
Conditions and MedDRA coding
Patients undergoing plastic surgical procedures with wounds that would normally receive application of TXA to reduce bleeding after surgery.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Patients are to undergo a surgical procedure within the field of plastic surgery where the procedure involves use of topical TXA at the participating center.
- Patients are over 18 years of age and capable of independently providing informed consent.
- Patients have received adequate oral and written information about the study and signed the informed-consent form .
Exclusion criteria 1
- Patients with known allergy to tranexamic acid.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Given one or several of the following occurrences, re-bleeding will be defined as “yes”: Re-operation, surgical exploration or evacuation, aspiration, blood transfusion or external extra compression due to hematoma within the first postoperative 10 days
Secondary endpoints 5
- Postoperative wound infection: Infection within the first 30 days requiring any of the following: Extra outpatient follow-up, re-operation, or revision or antibiotic treatment.
- Postoperative wound rupture: Wound rupture within the first 30 days requiring any of the following: Extra outpatient follow-up, re-operation, or revision.
- Thromboembolic events defined as thrombophlebitis, deep venous thrombosis, pulmonary embolus, cerebral or coronary infarctions until 30 days postoperatively.
- Seroma defined as the need for aspiration of fluids, or spontaneous evacuation of voluminous fluids, between 10 and 30 days postoperatively.
- Other possible adverse effects causing contact with the health service until 30 days postoperatively.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Cyklokapron 100 mg/ml injeksjons-/infusjonsvæske, oppløsning
PRD3907139 · Product
- Active substance
- Tranexamic Acid
- Substance synonyms
- LB1148, 4-(AMINOMETHYL)CYCLOHEXANE-1-CARBOXYLIC ACID, AMCA, TRANS-AMCHA
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- TOPICAL
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 500 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B02AA02 — TRANEXAMIC ACID
- Marketing authorisation
- 0000-05335
- MA holder
- PFIZER AS
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Re-labelling
Placebo 1
CHLORURE DE SODIUM 0,9 % LAVOISIER, solution pour perfusion
PRD470771 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- TOPICAL
- Max daily dose
- 5 ml millilitre(s)
- Max total dose
- 5 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05XA03 — SODIUM CHLORIDE
- Marketing authorisation
- 34009 363 405 3 4
- MA holder
- LABORATOIRES CHAIX ET DU MARAIS
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Re-labelling
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
St. Olavs Hospital HF
- Sponsor organisation
- St. Olavs Hospital HF
- Address
- Prinsesse Kristinas G. 3
- City
- Trondheim
- Postcode
- 7030
- Country
- Norway
Scientific contact point
- Organisation
- St. Olavs Hospital HF
- Contact name
- Co-ordinating investigator
Public contact point
- Organisation
- St. Olavs Hospital HF
- Contact name
- Co-ordinating investigator
Locations
3 EU/EEA countries · 14 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Authorised, recruitment pending | 300 | 1 |
| Finland | Ongoing, recruiting | 200 | 1 |
| Norway | Ongoing, recruiting | 3,000 | 12 |
| Rest of world | — | 0 | — |
Investigational sites
Vestre Viken HF
Department of Surgery, Groenland 32, 3045, Drammen
Sykehuset Ostfold HF
Department of surgery, Section of plastic surgery, P. O. Box 16, 1603, Fredrikstad
Haraldsplass Diakonale Sykehus AS
Department of Plastic Surgery and Burns, Ulriksdal 8, 5009, Bergen
Sykehuset Telemark HF
Department of hand, plastic -and reconstructive surgery, Ulefossvegen 55, 3710, Skien
Helse Moere Og Romsdal HF
Molde, Department of surgery, Aasehaugen 5, 6017, Aalesund
Sykehuset Innlandet HF
Hamar, Department of plastic- and reconstructive surgery, Furnesvegen 26, 2382, Brumunddal
Helse Stavanger HF
Department of Plastic Surgery, Gerd-Ragna Bloch Thorsens Gate 8, 4011, Stavanger
Helse Bergen HF
Surgical department, Haukelandsveien 22, 5021, Bergen
St. Olavs Hospital HF
Department of plastic- and reconstructive surgery, Prinsesse Kristinas G. 3, 7030, Trondheim
Oslo University Hospital HF
Divison of Plastic and Reconstructive Surgery, Clinic of Surgery, Sognsvannsveien 20, 0372, Oslo
Sykehuset Innlandet HF
Tynset, Department of Plastic and Reconstructive Surgery, Furnesvegen 26, 2382, Brumunddal
Universitetssykehuset Nord-Norge HF
Department of plastic- and reconstructive surgery, Clinic of Surgery, Sykehusvegen 38, 9019, Tromsoe
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Finland | 2025-09-30 | 2025-10-06 | |||
| Norway | 2024-09-18 | 2024-10-01 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 16 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2023-510381-28-01_Redacted | 11.0 |
| Protocol (for publication) | D4_Patient facing document_questionnaire_FI | 1 |
| Protocol (for publication) | D4_Patient facing document_questionnaire_SE | 1.0 |
| Recruitment arrangements (for publication) | K1 Recruitment_Arrangements_DK | 4.0 |
| Recruitment arrangements (for publication) | K1 Recruitment_Arrangements_FI | 4.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_DK | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DK_appendix | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_EN | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_FI | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_NO | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_SE | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS_DK | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Cyklokapron_EN | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis FI_ 2023-510381-28-01 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NO_2023-510381-28-01 | 1 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-30 | Norway | Acceptable 2024-06-19
|
2024-06-19 |
| 2 | SUBSEQUENT ADDITION OF MSC | APP-2 | 2024-12-15 | 2025-03-19 | ||
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-01 | Norway | Acceptable | 2025-02-25 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-03-27 | Acceptable | 2025-03-27 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-27 | Norway | Acceptable 2025-06-02
|
2025-06-03 |
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2025-06-29 | 2025-09-14 | ||
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-03-13 | Norway | Acceptable | 2026-03-20 |