Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruitment pending
Participants planned
450
Countries
1
Sites
3
Deformity
To evaluate the effect of intraoperative tranexamic acid on postoperative infection rates after mid- and hindfoot arthrodesis at one year
Key facts
- Sponsor
- HUS-yhtymae
- 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], Diseases [C] - Musculoskeletal Diseases [C05]
- Decision date (initial)
- 2026-05-29
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Finnish State Funding via Helsinki University Hospital HUS
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
To evaluate the effect of intraoperative tranexamic acid on postoperative infection rates after mid- and hindfoot arthrodesis at one year
Secondary objectives 4
- Wound dehiscence
- Perioperative blood loss
- Revision surgery rate
- Fusion rate
Conditions and MedDRA coding
Deformity
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2026-526142-27-00 | Tranexamic Acid in Hind and Midfoot Arthrodesis Surgery: A Multicentre, Randomized, Placebo-Controlled Trial (TRASH Trial) | HUS-yhtymae |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Age ≥ 18 years
- A foot and ankle orthopedic surgeon has determined that the patient is suitable for a hind- or midfoot arthrodesis procedure
- Ability to understand trial information and answer outcome assessments in Finnish or in Swedish
Exclusion criteria 8
- Acute trauma
- Documented hypercoagulable disorder (inherited or acquired)
- History of seizures
- History of local bone or joint infection in the past 12 months
- Active bacterial infection or ulcer of the lower limb
- Diabetes mellitus and glycohaemoglobin (GHb-A1C > 64mmol/l)
- Patients with severe circulatory disorder of the lower limb, absence of palpable pulses in the foot
- Patient unable to provide consent
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Primary endpoint is a composite measure that combines superficial and deep SSIs up to one year. We will use the Centers for Disease Control and Prevention (CDC) definitions for SSI and categorise the infections as either superficial or deep.
Secondary endpoints 5
- Wound dehiscence is defined as either partial or total separation of the edges of previously approximated surgical wound with no signs of infection. The wound is assessed on at 2 weeks, 3 months and 12 months by a specialised nurse or a surgeon.
- Perioperative blood loss will be estimad by measuring haemoglobin levels on the day of surgery, both pre- and postoperatively, and reporting the absolute change in haemoglobin concentration (g/L).
- Cumulative revision surgery rate for any reason is reported up to 12 month follow-up. This includes any revision surgery performed in the operating room at the site of the initial surgery site.
- Fusion rate will be evaluated at the 12-month follow-up visit using a computed tomography scan. Arthrodesis will be considered fused if osseous bridging is observed as determined by the assessing radiologist.
- Exploratory endpoints will be collected and analysed, but the results will be evaluated separately: The Manchester–Oxford foot questionnaire (MOxFQ), Patient Acceptable Symptom State (PASS), Pain Numerical Rating Scale, Cost Effectiveness
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Tranexamic acid Baxter 100 mg/ml injektio-/infuusioneste, liuos
PRD11950029 · 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
- INFUSION
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 1000 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B02AA02 — TRANEXAMIC ACID
- Marketing authorisation
- 36718
- MA holder
- BAXTER HOLDING B.V.
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Sodium Chloride Intravenous Infusion BP 0.9% w/v Solution for Infusion.
PRD11824645 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 100 ml millilitre(s)
- Max total dose
- 100 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05BB01 — ELECTROLYTES
- Marketing authorisation
- PA 0179/002/007
- MA holder
- B. BRAUN MEDICAL LTD.
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
HUS-yhtymae
- Sponsor organisation
- HUS-yhtymae
- Address
- Stenbackinkatu 9
- City
- Helsinki
- Postcode
- 00290
- Country
- Finland
Scientific contact point
- Organisation
- HUS-yhtymae
- Contact name
- Sami Kormi, MD, PhD Orthopaedic Surgeon, Department of Orthopaedics and Traumatology
Public contact point
- Organisation
- HUS-yhtymae
- Contact name
- Sami Kormi, MD, PhD Orthopaedic Surgeon, Department of Orthopaedics and Traumatology
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Authorised, recruitment pending | 450 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | TRASH trial protocol v1 | 1 |
| Recruitment arrangements (for publication) | TRASH informedconsent_patientrecruitmentprocedure_fi | 1 |
| Subject information and informed consent form (for publication) | TRASH Tiedote ja suostumus tutkimuksesta | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | TRASH SmPC Summary of product characteristics tranexamic aced baxter | 1 |
| Synopsis of the protocol (for publication) | TRASH trial synopsis | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-04-08 | Finland | Acceptable 2026-05-29
|
2026-05-29 |