Overview
Sponsor-declared trial summary
Osteoarthritis
In this RCT-study we investigate the potential additive effect of intraarticular injected Tranexamic Acid (TXA) for the total blood loss in unilateralt total hip arthroplasty in addition to conventional treatment with IV TXA. The intervention group will be given IV TXA at the start of surgery + injection of TXA into th…
Key facts
- Sponsor
- Region Hovedstaden
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]
- Trial duration
- 18 Oct 2022 → ongoing
- Decision date (initial)
- 2024-11-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517398-26-01
- EudraCT number
- 2020-003321-32
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety, Therapy
In this RCT-study we investigate the potential additive effect of intraarticular
injected Tranexamic Acid (TXA) for the total blood loss in
unilateralt total hip arthroplasty in addition to conventional treatment
with IV TXA. The intervention group will be given IV TXA at the start of
surgery + injection of TXA into the joint (end surgery) VS. TXA at the
start of surgery + injection af equal volume of NaCl (placebo).Primary
endpoint is total blood loss 24 hours after surgery.
Secondary objectives 1
- Secondary endpoints is total bleeding 2 days after surgery, likewise the amount of blood transfusion and the thromboembolic events within the first 90 days of surgery.
Conditions and MedDRA coding
Osteoarthritis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10020108 | Hips osteoarthritis | 10028395 |
| 27.0 | LLT | 10090417 | Hip osteoarthritis | 100000004859 |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-517398-26-00 | Evaluation of intra articular Tranexamic acid for reduction of total blood loss in total hip arthroplasty | Hvidovre Hospital |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- ≥ 18 years
- Undergoing surgery for unilateral total hip arthroplasty
- Able to give ones consent either verbally or written.
Exclusion criteria 16
- - Operation performed in general anaesthesia
- - Allergi to TXA
- - In treatment with the following anticoagulatia: ADP receptorinhibitors, vitamin-K antagonist(within 5-7 days before the operation). Factor Xa inhibitors, thrombine-inhibitors
- - Use of oral anticonceptiva
- - Known with thrombophilia
- - Reduced kidney function (GFR <45 ml/hour)
- - Participated in a clinical trial within the last 30 days
- - Alcoholism and morphinism
- - Females: menstruation within the last 12 months
- - Patients who are not able to speak and understand Danish
- - Patients who refuse to receive blood products
- - Present acute thromboembolic event (DVT, AMI, cerebral infarction, pulmonary embolism)
- - Disseminated intravascular coagulation (DIC) or active thromboembolic disease
- - Active cancer disease
- - Had one of the following type of trauma or surgeries in the affected hip: Hip fractures, periacetabulær osteotomy, femurosteotomy, trochanterostetomi.
- - Rheumatic arthritis.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Total blood loss 24 hours after the operation
Secondary endpoints 1
- Total blood loss on the morning af the 2nd postoperative day.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Tranexamic Acid 100 mg/ml Solution for Injection
PRD10335099 · Product
- Active substance
- Tranexamic Acid
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRA-ARTICULAR INJECTION
- Max daily dose
- 3 g gram(s)
- Max total dose
- 5 g gram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B02AA02 — TRANEXAMIC ACID
- Marketing authorisation
- PL 11311/0613
- MA holder
- TILLOMED LABORATORIES LTD
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Hovedstaden
- Sponsor organisation
- Region Hovedstaden
- Address
- Kettegaard Alle 30
- City
- Hvidovre
- Postcode
- 2650
- Country
- Denmark
Scientific contact point
- Organisation
- Hvidovre Hospital
- Contact name
- Christian Skovgaard Nielsen
Public contact point
- Organisation
- Hvidovre Hospital
- Contact name
- Mads Koefoed Hansen
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| GCP unit at University of Copenhagen ORL-000005038
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 100 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Denmark | 2022-10-18 | 2022-10-18 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol | 1 |
| Recruitment arrangements (for publication) | This aspect | 1 |
| Subject information and informed consent form (for publication) | Deltagerinformation med samtykke og underskrift for TXA-projekt patientens del | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Tranexamsyre Pfizer injektions infusionsvske oplsning 100 mg ml | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-22 | Denmark | Acceptable 2024-11-14
|
2024-11-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-11-17 | Denmark | Acceptable 2025-12-10
|
2025-12-11 |