Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
5,945
Countries
8
Sites
77
Stroke
To assess the clinical effectiveness of TXA after ICH and determine whether TXA should be used in clinical practice. Primary objective: To assess the effect of TXA on early death (≤7days)
Key facts
- Sponsor
- University Of Nottingham
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 6 Jul 2023 → ongoing
- Decision date (initial)
- 2023-05-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme (NIHR
External identifiers
- EU CT number
- 2022-500587-35-01
- ISRCTN
- ISRCTN97695350
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To assess the clinical effectiveness of TXA after ICH and determine whether TXA should be used in clinical practice.
Primary objective: To assess the effect of TXA on early death (≤7days)
Secondary objectives 1
- To assess the effect of TXA on dependency 6 months after ICH
Conditions and MedDRA coding
Stroke
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Trial Design Pragmatic phase III prospective blinded randomised placebo-controlled trial performed in two phases: a 30-month internal pilot phase with pre-specified progression criteria then main phase (approximately 145 centres, recruit to a total of 5500 participants).
There will be no break in recruitment as the trial proceeds from the start-up phase to the main phase unless the pre-specified stopping criteria are met.
Appendix 1 (attached) shows a schematic diagram of trial design, procedures and stages, randomisation, baseline & intermediate visits, final visit, and long-term follow-up.
Randomisation will be to TXA vs. placebo in a 1:1 ratio.
Due to the emergency situation, a straightforward randomisation process will be used, where sites will simply select the next available treatment pack, which will be a numbered box containing either TXA or placebo according to a computer-defined sequence. Boxes will be identical with the exception of the treatment pack number. Randomisation will be stratified by site with supply to each site balanced for TXA and placebo, using random permuted blocks of varying size. The IMP manufacturer will prepare blinded individual treatment packs containing four 5ml glass ampoules of TXA 500mg or sodium chloride 0.9% which will be very similar in appearance.
|
Randomised Controlled | Double | [{"id":177370,"code":5,"name":"Carer"},{"id":177369,"code":3,"name":"Monitor"},{"id":177368,"code":2,"name":"Investigator"},{"id":177367,"code":1,"name":"Subject"}] | Intravenous tranexamic acid: Intravenous tranexamic acid 2g: 1g loading dose given as 100 mls infusion over 10 minutes, followed by 1g in 250 mls infused over 8 hours. Placebo: Matching placebo (normal saline 0.9%) administered by an identical regimen. |
Regulatory references
- Scientific advice from competent authorities
- Medicines And Healthcare Products Regulatory Agency
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2022-500587-35-00 | Tranexamic acid for hyperacute spontaneous IntraCerebral Haemorrhage (TICH-3) | University Of Nottingham |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Inclusion criteria: i. Adults (≥ 18 years) ii. Presenting within 4.5 h of onset of acute spontaneous ICH iii. ICH confirmed on brain imaging iv. When onset of symptoms is unknown patient must be within 4.5 hours of symptom discovery and have no other exclusion criteria. v. Patients taking direct oral anticoagulants can be included vi. Informed consent according to Article 35 of (EU) No 536/2014 vii. Please see separate document for EU country specific Descriptors – see Protocol Appendix 2 and Part II document
Exclusion criteria 1
- Exclusion Criteria: viii. Patient with a known recommended indication for TXA treatment (e.g. traumatic brain injury). ix. Patients with contraindication to TXA in view of treating physician should be excluded. I.e where the contraindication outweighs the risk of giving TXA to a patient as an emergency ICH treatment: a. Active seizures b. Current diagnosis of acute venous or arterial thrombosis c. Hypersensitivity to TXA or normal saline d. Patients with known underlying structural abnormality such as arteriovenous malformation, aneurysm, tumor. An underlying structural abnormality does not need to be excluded before enrolment, but where known, patients should not be recruited. x. Patient known to be taking therapeutic anticoagulation with warfarin or low molecular weight heparin at time of enrolment. Patients taking direct oral anticoagulants are not excluded xi. Massive ICH for which haemostatic treatment seems futile (This would ordinarily be when haematoma volume is estimated as larger than 60ml) xii. Severe coma (Glasgow Coma Scale <5) xiii. Decision already taken for palliative (end of life) care with withdrawal of active treatment
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Primary outcome: Early death up to and including day 7 after ICH onset. Justification of primary outcome: Functional outcome using the mRS at 90 days is the recommended outcome measure after stroke. However, our hypothesis is that TXA improves outcome by stopping HE. HE is the most common cause of early death after ICH, TXA is a haemostatic therapy, therefore we believe early mortality ≤7 days is the most appropriate outcome for TICH-3.
Secondary endpoints 1
- To assess the effect of TXA on dependency 6 months after ICH
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Cyklokapron 100mg/mL solution for injection/infusion
PRD717345 · Product
- Active substance
- Tranexamic Acid
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 2 g gram(s)
- Max total dose
- 2 g gram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B02AA02 — TRANEXAMIC ACID
- Marketing authorisation
- PL 00057/0952
- MA holder
- PFIZER LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Labels
Placebo 1
Sodium Chloride Injection BP 0.9% w/v
PRD301483 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 2 g gram(s)
- Max total dose
- 2 g gram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05XA — ELECTROLYTE SOLUTIONS
- Marketing authorisation
- 01502 / 0006R
- MA holder
- HAMELN PHARMA LTD
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Packaging & Labelling Sharp Clinical Services Ltd will prepare blinded individual treatment packs containing four 5ml glass ampoules of tranexamic acid 500mg or sodium chloride 0.9% which will be very similar in appearance by the addition of a heat shrink sleeving. Ampoules and the secondary carton will be labelled in accordance with Annex 13 of Volume 4 of The Rules Governing Medicinal Products in the EU: Good Manufacturing Practices, assuming that the primary and secondary packaging remain together throughout the trial. To facilitate identification the carton and the ampoules contained within it will be labelled with the same unique pack number. Detailed prescribing and administration instructions will be provided in the treatment pack (available on the TICH-3 trial website). The final product will be QP released by the designated person at Sharp Clinical Services to provide blinded trial treatment packs for this trial. Participant Treatment Packs are delivered to the hospital pharmacy from Sharp Clinical Services Ltd
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
University Of Nottingham
- Sponsor organisation
- University Of Nottingham
- Address
- Derby Road
- City
- Nottingham
- Postcode
- NG7 2UH
- Country
- United Kingdom
Scientific contact point
- Organisation
- University Of Nottingham
- Contact name
- Prof Niki Sprigg
Public contact point
- Organisation
- University Of Nottingham
- Contact name
- Prof Niki Sprigg
Locations
8 EU/EEA countries · 77 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 445 | 6 |
| Finland | Ongoing, recruiting | 40 | 1 |
| France | Ongoing, recruiting | 496 | 16 |
| Ireland | Ongoing, recruiting | 100 | 7 |
| Italy | Ongoing, recruiting | 500 | 26 |
| Norway | Ongoing, recruiting | 100 | 6 |
| Spain | Ongoing, recruiting | 100 | 6 |
| Sweden | Ongoing, recruitment ended | 180 | 9 |
| Rest of world
Switzerland, Malaysia, United Kingdom
|
— | 3,984 | — |
Investigational sites
Aalborg University Hospital
Neurology, Hospitalsbyen 1, 9260, Gistrup
Copenhagen University Hospital
Neurology, Bispebjerg Bakke 23, 2400, Copenhagen Nv
Region Sjaelland
Neurology, Vestermarksvej 6, 4000, Roskilde
Rigshospitalet
Neurology, Inge Lehmanns Vej 7, 2100, Copenhagen Oe
Odense University Hospital
Neurology, J. B. Winsloews Vej 4, 5000, Odense C
Aarhus University Hospital
Neurology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
CHU De Rouen
Service de neurologie vasculaire, 1 Rue De Germont, 76031, Rouen Cedex
Centre Hospitalier Universitaire De Nantes
Unité neurovasculaire, 5 Allee De L Ile Gloriette, 44093, Nantes Cedex 1
Centre Hospitalier Universitaire De Bordeaux
Unité neurovasculaire, Place Amelie Raba Leon, 33700, Bordeaux
Pitie Salpetriere Hospital
Service des urgences cérébro-vasculaires, 43 Boulevard De L Hopital, 75013, Paris
Centre Hospitalier Sainte Anne Paris
Department of Neurology, GHU Paris Psychiatrie et Neurosciences, 1 Rue Cabanis, 75014, Paris
Centre Hospitalier Sud Francilien
Service de Neurologie du Pr Smadja, 40 Avenue Serge Dassault, 91100, Corbeil Essonnes
Hospital Foch
Service de Neurologie et Unité Neurovasculaire, 40 Rue Worth, 92150, Suresnes
Assistance Publique Hopitaux De Paris
Département de Neurologie, 2 Rue Ambroise Pare, 75475, Paris Cedex 10
CHUR Of Besançon
Neurology / Stroke, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Centre Hospitalier De Versailles
Service de neurologie, 177 Rue De Versailles, 78150, Le Chesnay
Centre Hospitalier Universitaire De Dijon
Service de Neurologie, 14 Rue Paul Gaffarel, 21000, Dijon
CHU De Toulouse
Neurology / Stroke, 1 Av Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Timone University Hospital
Unité neurovasculaire, 265 Rue Saint Pierre, 13005, Marseille
Centre Hospitalier Universitaire De Poitiers
Service de Neurologie, 2 Rue De La Miletrie, 86000, Poitiers
CHRU Lille - Hopital Roger Salengro
Service de neurologie et pathologie neurovasculaire, Avenue Du Professeur Emile Laine, 59037, Lille Cedex
Hospices Civils De Lyon
Service de neurologie vasculaire, 59 Boulevard Pinel, 69394, Lyon Cedex 03
St. Vincent's University Hospital
Stroke, Elm Park, DUB LIN4, Dublin 4
University Hospital Limerick
Stroke, Saint Nessans Road Dooradoyle, Ireland, Limerick
Beaumont Hospital
Stroke, Beaumont Road, Beaumont, Dublin 9
University Hospital Waterford
Stroke, Dunmore Road, X91 ER8E, Waterford
Cork University Hospital
Stroke, Wilton, Ireland, Cork
Tallaght University Hospital
Stroke, 24 Rep Ireland, Ireland, Dublin
Mater Misericordiae University Hospital
Neurology / Stroke, Eccles Street, Ireland, Dublin 7
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
UOC Neurologia con Stroke Unit, Via Trabucco 180, 90146, Palermo
Azienda Unita Sanitaria Locale Di Modena
Medicina Interna e Riabilitativa, Via Guido Molinari 1, 41012, Carpi
Azienda Istituti Ospitalieri Di Cremona
Stroke, Viale Concordia 1, 26100, Cremona
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo
Neurologia e Stroke Unit, Via Antonio Di Rudini' 8, 20142, Milan
ARNAS G. Brotzu
Stroke / Neurology, Piazzale Alessandro Ricchi 1, 09121, Cagliari
San Camillo Forlanini Hospital
UOSD Stroke Unit, Circonvallazione Gianicolense 87, 00152, Rome
IRCCS Ospedale Policlinico San Martino
Neuroscienze, Viale Europa, 32100, Belluno
Ospedale Santa Maria Annunziata
Neurologia e Stroke Unit, Via Dell' Antella 58, 50012, Bagno A Ripoli
Azienda Sanitaria Locale Napoli 2 Nord
Medicina d’Emergenza, Via Michelangelo Lupoli 27, 80027, Frattamaggiore
Asst Di Mantova
Neurology, Strada Lago Paiolo 10, 46100, Mantova
Azienda Ospedaliero-Universitaria Maggiore Della Carita
SCDU Neurologia, Corso Giuseppe Mazzini 18, 28100, Novara
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Neurologia/BIND, Via Del Vespro 129, 90127, Palermo
University Hospital Of Perugia
Stroke Unit, Via Gerardo Dottori 1, 06132, Perugia
Universita Di Pisa
Dipartimento di MedicinaClinica e SperimentaleUniversita Pisa, Via Roma 55, 56126, Pisa
Azienda Socio Sanitaria Territoriale Ovest Milanese
UOC NEUROLOGIA - STROKE UNIT, Via Papa Giovanni Paolo II, 20025, Legnano
University Of Rome Tor Vergata
Dip. di Medicina dei Sistemi, Via Della Ricerca Scientifica 1, 00133, Rome
Careggi University Hospital
Stroke, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
University Of L'Aquila
Dipartimento di Scienze Cliniche Applicate e Biotecnologiche, Via Vetoio Snc, 67100, L'aquila
Azienda Unita Sanitaria Locale Toscana Nord Ovest
Neurology, Via Enrico Mattei 21, 54100, Massa
University Of Bari Aldo Moro
UOC NEUROLOGIA e STROKE UNIT “F. PUCA, Piazzale Giulio Cesare 11, 70124, Bari
Azienda Sanitaria Universitaria Giuliano Isontina
MEDICINE SPECIALISTICHE AREA GIULIANA – CLINICA NEUROLOGICA, Via Costantino Costantinides 2, 34128, Trieste
Azienda Ospedaliera Ospedale Niguarda CA' Granda
Stroke Unit e Neurologia, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
UOC Neurologia e Stroke Unit, Via Antonio Cardarelli 9, 80131, Naples
University Of Cagliari
SC Neurologia, S P 8 Km 0 700, 09042, Monserrato
Alessandro Manzoni Hospital
Neurologia-Stroke Unit, Via Dell' Eremo 9, 23900, Lecco
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Neurology, Piazza Oms 1, 24127, Bergamo
Oslo University Hospital Hf
Stroke Unit, Trondheimsveien 235, 0586, Oslo
Helse More Og Romsdal HF
stroke and geriatrics, Åsehaugen 1, 6017, Ålesund
Akershus University Hospital
Stroke, Sykehusveien 27, 1478, Lorenskog
Helse Bergen HF
Dept of Neurology, Haukelandsveien 22, 5021, Bergen
Sorlandet Sykehus HF
Stroke, Egsveien 100, 4615, Kristiansand S
Nordlandssykehuset HF
Stroke, Parkveien 95, 8005, Bodo
University Of Valladolid
Neurology / Stroke, Avenida De Ramon Y Cajal S/n, 47005, Valladolid
Hospital Universitari Vall D Hebron
Neurology / Stroke, Passeig De La Vall D Hebron 119-129, 08035, Barcelona
University Hospital Ramón Y Cajal
Neurology / Stroke, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital De La Santa Creu I Sant Pau
Neurology / Stroke, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Complexo Hospitalario Universitario A Coruña
Neurology / Stroke, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital Universitari De Girona Doctor Josep Trueta
Neurology / Stroke, Avinguda De Franca S/n, 17007, Girona
Danderyds Sjukhus AB
Neurology / Stroke, Morbygardsvagen 88, 182 88, Danderyd
Uppsala University Hospital
Neurology / Stroke, Dag Hammarskjolds Vag 20, Uppsala Domkyrkofors., Uppsala
Region Skane Hassleholm Hospital
Stroke / Neurology, Esplanadgatan 19, 281 38, Hassleholm
Karolinska University Hospital
Neurology, Norrbacka S3 02, 171 76, Stockholm
Region Skane Skanes Universitetssjukhus
Neurology, Jan Waldenstroms Gata 16 Plan 5, Malmo St Johannes, Malmo
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Neurology, Bla Straket 5, Goteborgs Annedal, Goteborg
Oskarshamns Sjukhus Region Kalmar Laen
Neurologi & Internmedicin, Rosvagen 1, 572 51, Oskarshamn
Soedersjukhuset AB
Neurology, Sjukhusbacken 10, Hogalid, Stockholm
Region Vaesternorrland
Stroke, Lasarettsvagen 21, 856 43, Sundsvall
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 | 2023-07-28 | 2023-11-24 | |||
| Finland | 2023-07-06 | 2023-09-03 | |||
| France | 2023-11-23 | 2024-01-18 | |||
| Ireland | 2023-12-22 | 2024-03-20 | |||
| Italy | 2023-08-03 | 2023-10-03 | |||
| Norway | 2025-05-28 | 2025-05-28 | |||
| Spain | 2024-07-26 | 2024-07-29 | |||
| Sweden | 2024-03-08 | 2025-02-12 | 2026-04-01 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 4 · Art. 38 CTR
Temporary halt TH-126820
- Halt date
- 2026-04-01
- Planned restart
- 2026-04-07
- Member states concerned
- Spain
- Publication date
- 2026-04-01
- Reason
- Medicinal Product related
- Explanation
- Some EU countries (France, Italy, Spain, Sweden) have drug that goes out of date on 31/3/2026. New drug is being shipped but will not be available until early-mid April.
Delayed contracting between University of Nottingham (coordinating centre/sponsor) and Sharp (manufacturer and distributor of IMP. This almost resolved.
Treatment has been stopped only in those EU countries where drug shelf life runs out on 31/3/2026. Other EU countries (Denmark, Finland, Ireland) with drugs that expire in December 2026 will continue to enrol and treat participants. Similarly, non-affected EU countries will continue (Malaysia, Switzerland, UK). - Follow-up measures
- Will continue as per protocol.
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Temporary halt TH-126822
- Halt date
- 2026-04-01
- Planned restart
- 2026-04-07
- Member states concerned
- France
- Publication date
- 2026-04-01
- Reason
- Medicinal Product related
- Explanation
- Some EU countries (France, Italy, Spain, Sweden) have drug that goes out of date on 31/3/2026. New drug is being shipped but will not be available until early-mid April.
Delayed contracting between University of Nottingham (coordinating centre/sponsor) and Sharp (manufacturer and distributor of IMP. This almost resolved.
Treatment has been stopped only in those EU countries where drug shelf life runs out on 31/3/2026. Other EU countries (Denmark, Finland, Ireland) with drugs that expire in December 2026 will continue to enrol and treat participants. Similarly, non-affected EU countries will continue (Malaysia, Switzerland, UK). - Follow-up measures
- Will continue as per protocol.
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Temporary halt TH-126816
- Halt date
- 2026-04-01
- Planned restart
- 2026-04-07
- Member states concerned
- Italy
- Publication date
- 2026-04-01
- Reason
- Medicinal Product related
- Explanation
- Some EU countries (France, Italy, Spain, Sweden) have drug that goes out of date on 31/3/2026. New drug is being shipped but will not be available until early-mid April.
Delayed contracting between University of Nottingham (coordinating centre/sponsor) and Sharp (manufacturer and distributor of IMP. This almost resolved.
Treatment has been stopped only in those EU countries where drug shelf life runs out on 31/3/2026. Other EU countries (Denmark, Finland, Ireland) with drugs that expire in December 2026 will continue to enrol and treat participants. Similarly, non-affected EU countries will continue (Malaysia, Switzerland, UK). - Follow-up measures
- Will continue as per protocol.
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Temporary halt TH-126818
- Halt date
- 2026-04-01
- Planned restart
- 2026-04-07
- Member states concerned
- Sweden
- Publication date
- 2026-04-01
- Reason
- Medicinal Product related
- Explanation
- Some EU countries (France, Italy, Spain, Sweden) have drug that goes out of date on 31/3/2026. New drug is being shipped but will not be available until early-mid April.
Delayed contracting between University of Nottingham (coordinating centre/sponsor) and Sharp (manufacturer and distributor of IMP. This almost resolved.
Treatment has been stopped only in those EU countries where drug shelf life runs out on 31/3/2026. Other EU countries (Denmark, Finland, Ireland) with drugs that expire in December 2026 will continue to enrol and treat participants. Similarly, non-affected EU countries will continue (Malaysia, Switzerland, UK). - Follow-up measures
- Will continue as per protocol.
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Unexpected events 1 · Art. 53 CTR
Note: SUSARs are reported via EudraVigilance, not CTIS — events shown here are CTIS-public notifications only.
Unexpected event UE-125023
- Event date
- 2026-03-16
- Date aware
- 2026-03-17
- Submission date
- 2026-03-24
- Member states affected
- Ireland, Italy, Denmark, Spain, Finland, Sweden, France, Norway
- Event description
- On March 16, 2026, a night-nurse at our trial site at Odense University Hospital, Denmark (Department of
Neurology) was asked to administer tranexamic acid to a patient with intracranial haemorrhage after
thrombolysis treatment (i.e. not a trial participant). The nurse was relatively new at the department. The
nurse was looking for the correct medicine in the department's medication room but had difficulties finding
the correct medicine. Unfortunately, the nurse found the TICH-3 trial IMP in the medication room. The trial
medication is stored in a separate box labelled "TICH-3 study medication" and the initials of the local PI
added. The patient in question was subsequently administered the trial medication in the belief that it was
tranexamic acid for clinical use. When the clinical staff became aware of the incidence, they elected to speed
up the administration of a second dose of tranexamic acid. The PI at the site was informed about the
incidence the next morning. It was the assessment of the PI and the clinical staff at the site, that unblinding
the IMP was not needed. The patient and the patient’s relatives have been informed about the incidence,
and the incidence has been noted in the patient’s medical chart.
The PI reported the incidence the next day to the central trial office and the national coordinator of the TICH
3 trial in Denmark. The Danish GCP-unit was informed on the same day. The central trial office initially asked
for a written exposition of the incidence (note-to-file) and the submission of a protocol violation. The GCP
unit (the GCP-unit in Odense and in Copenhagen) consulted with the GCP units head-of-quality and did not
find reasons to submit the incidence as a “Serious Breach”.
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 67 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_TICH-3 Protocol MASTER EU Clean EU CT No 2022-500587-35-01 | 1 |
| Protocol (for publication) | D1_TICH-3 Protocol MASTER EU Tracked Changes EU CT no 2022-500587-35-01 | 1 |
| Recruitment arrangements (for publication) | forfarande-for-rekrytering-och-samtyckesprocess | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements Norway | 2.0 |
| Recruitment arrangements (for publication) | Model for collection of informed consent at danish sites | 1.3 |
| Recruitment arrangements (for publication) | NREC-CT-Recruitement-and-informed-consent-procedure-templat-V1 final | 1 |
| Recruitment arrangements (for publication) | Recruitment arrangements informed consent procedures for Danish sites | 1.5 |
| Recruitment arrangements (for publication) | Recruitment arrangements informed consent procedures for Danish sites_marked_version | 1.5 |
| Recruitment arrangements (for publication) | Recruitment procedure TICH3 Fr | 1 |
| Recruitment arrangements (for publication) | Signature V1 TICH3 FR | 1 |
| Recruitment arrangements (for publication) | Site recruitment France TICH3Fr | 1 |
| Recruitment arrangements (for publication) | TICH-3 Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | TICH-3 Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | TICH-3 Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | TICH-3 Recruitment Arrangements | 1 |
| Subject information and informed consent form (for publication) | Attestation d urgence Clause d urgence TICH3 FR | 1 |
| Subject information and informed consent form (for publication) | Consenso per partecipante | 1 |
| Subject information and informed consent form (for publication) | Consent form_Direct patient consent_TICH-3 | 1.1 |
| Subject information and informed consent form (for publication) | Consent form_Personal legal representative relative_TICH-3 | 1.1 |
| Subject information and informed consent form (for publication) | Consent form_Professional legal representative_TICH-3 | 1.1 |
| Subject information and informed consent form (for publication) | Family doctor letter international | 1 |
| Subject information and informed consent form (for publication) | Forskningspersonsinformation Radda hjarnblodningen | 2.2 |
| Subject information and informed consent form (for publication) | Inf privacy TICH 3 ASST MN Coordinatore | 1 |
| Subject information and informed consent form (for publication) | Inf privacy TICH 3 Modello CentriIT | 1 |
| Subject information and informed consent form (for publication) | Information for legal representatives relatives Denmark tracked version | 1.5 |
| Subject information and informed consent form (for publication) | Information for legal representatives relatives_Denmark | 1.5 |
| Subject information and informed consent form (for publication) | Information for professional legal representatives Denmark tracked version | 1.5 |
| Subject information and informed consent form (for publication) | Information for professional legal representatives_Denmark | 1.5 |
| Subject information and informed consent form (for publication) | L1_Norway Information Form and Consent TICH 3 | 1.1 |
| Subject information and informed consent form (for publication) | L1_Standardisert muntlig informasjon ved inklusjon i TICH | 2.0 |
| Subject information and informed consent form (for publication) | Modulo di esonero medico indipendente | 1 |
| Subject information and informed consent form (for publication) | Mun Info | 2.0 |
| Subject information and informed consent form (for publication) | NICE Patient poursuite TICH3 FR | 1.2 |
| Subject information and informed consent form (for publication) | NICE Patient TICH3 FR | 1.2 |
| Subject information and informed consent form (for publication) | NICE Proche TICH3 FR | 1.2 |
| Subject information and informed consent form (for publication) | NICE Proche poursuite TICH3 FR | 1.2 |
| Subject information and informed consent form (for publication) | Participant Full Consent Form TICH3 Final Ireland | 1 |
| Subject information and informed consent form (for publication) | Participant Information Sheet TICH3 Final Ireland | 1 |
| Subject information and informed consent form (for publication) | Participant Short Information Sheet TICH3 Final Ireland | 1 |
| Subject information and informed consent form (for publication) | Patient information Denmark tracked version | 1.6 |
| Subject information and informed consent form (for publication) | Patient information_Denmark | 1.6 |
| Subject information and informed consent form (for publication) | Professional Legal Rep Full Consent Form TICH3 Final Ireland | 1 |
| Subject information and informed consent form (for publication) | Professional Legal Rep Information Sheet TICH3 Final Ireland | 1 |
| Subject information and informed consent form (for publication) | Professional Legal Rep Short Information Sheet and Consent TICH3 Final Ireland | 1 |
| Subject information and informed consent form (for publication) | Relative Legal Rep Short Information TICH3 Final Ireland | 1 |
| Subject information and informed consent form (for publication) | Relative Legal Rep Full Consent Form TICH3 Final Ireland | 1 |
| Subject information and informed consent form (for publication) | Relative Legal Rep Information Sheet TICH3 Final Ireland | 1 |
| Subject information and informed consent form (for publication) | Rights of participants in research projects_Denmark | 1.0 |
| Subject information and informed consent form (for publication) | Samrad | 2.0 |
| Subject information and informed consent form (for publication) | Samrads information Radda hjarnblodningen | 2.2 |
| Subject information and informed consent form (for publication) | SCHEDA INF BREVE PARENTI | 1 |
| Subject information and informed consent form (for publication) | SCHEDA INF BREVE PZ | 1 |
| Subject information and informed consent form (for publication) | SCHEDA INFORMATIVA PARTECIPANTI FULL | 1 |
| Subject information and informed consent form (for publication) | TRACKED NOK PILFS Samrads information Radda hjarnblodningen tracked changes in Swedish v1 0 to v2 2 | 2.2 |
| Subject information and informed consent form (for publication) | TRACKED Patient PILF Radda hjarnblodningen tracked changes in Swedish v1 2 to v2 2 | 2.2 |
| Subject information and informed consent form (for publication) | TRACKED Short NOK PIS Samrad tracked changes version 1 0 to version 2 0 | 2.0 |
| Subject information and informed consent form (for publication) | TRACKED Short patient PIS Mun Info tracked changes version 1 0 to version 2 0 Swedish | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2 _SmPc_ADVANZ FOCUS Tranexamic Acid 100mg ml Solution for Injection SmPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SPC_ADVANZ FOCUS Tranexamic Acid 100mg ml Solution for Injection SmPC x | 1 |
| Synopsis of the protocol (for publication) | D1_TICH-3 SYNOPSIS ES EU CT No2022-500587-35-01 | 1 |
| Synopsis of the protocol (for publication) | D1_TICH-3 SYNOPSIS FR EU CT No2022-500587-35-01 | 1 |
| Synopsis of the protocol (for publication) | D1_TICH-3 SYNOPSIS IT EU CT No2022-500587-35-01 | 1 |
| Synopsis of the protocol (for publication) | D1_TICH-3 SYNOPSIS NO EU CT No2022-500587-35-01 | 1 |
| Synopsis of the protocol (for publication) | D1_TICH-3 SYNOPSIS SE EU CT No2022-500587-35-01 | 1 |
| Synopsis of the protocol (for publication) | D1_TICH-3 Synopsis_ENG EU CT No2022-500587-35-01 | 1 |
| Synopsis of the protocol (for publication) | D1_TICH-3 Synopsis_FI EU CT No2022-500587-35-01 | 1 |
| Synopsis of the protocol (for publication) | D6_TICH-3 France CTIS EU Query EU CTIS No 2022-500587-35-01 | 1 |
Application history
25 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-01-18 | Ireland | Acceptable with conditions 2023-04-19
|
2023-04-24 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-05-15 | Acceptable with conditions 2023-04-19
|
2023-05-15 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-06-02 | Ireland | Acceptable with conditions 2023-04-19
|
2023-06-02 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2023-06-14 | Ireland | Acceptable with conditions 2023-04-19
|
2023-06-14 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-06-19 | Ireland | Acceptable 2023-09-14
|
2023-09-14 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2023-09-20 | 2023-09-20 | ||
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-09-20 | Acceptable | 2023-11-06 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-03-14 | Ireland | Acceptable | 2024-05-10 |
| 9 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-03-21 | Acceptable | 2024-05-06 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-05-22 | Ireland | Acceptable | 2024-06-13 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2024-10-08 | Acceptable | 2024-10-08 | |
| 12 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2024-12-10 | Ireland | Acceptable | 2024-12-10 |
| 13 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-03-11 | Acceptable | 2025-04-19 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-03-14 | Acceptable | 2025-05-20 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-05-16 | Acceptable | 2025-07-21 | |
| 16 | SUBSTANTIAL MODIFICATION | SM-12 | 2025-05-28 | Acceptable | 2025-05-28 | |
| 17 | SUBSTANTIAL MODIFICATION | SM-13 | 2025-07-02 | Acceptable | 2025-08-25 | |
| 18 | SUBSTANTIAL MODIFICATION | SM-14 | 2025-08-29 | Acceptable | 2025-09-30 | |
| 19 | SUBSTANTIAL MODIFICATION | SM-15 | 2025-10-03 | Acceptable | 2025-10-17 | |
| 20 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2025-11-04 | Ireland | Acceptable | 2025-11-04 |
| 21 | SUBSTANTIAL MODIFICATION | SM-16 | 2025-11-07 | Acceptable | 2026-01-08 | |
| 22 | SUBSTANTIAL MODIFICATION | SM-17 | 2025-12-12 | Acceptable | 2026-01-23 | |
| 23 | SUBSTANTIAL MODIFICATION | SM-18 | 2025-12-19 | Acceptable | 2026-01-14 | |
| 24 | SUBSTANTIAL MODIFICATION | SM-19 | 2026-01-20 | Acceptable | 2026-01-29 | |
| 25 | NON SUBSTANTIAL MODIFICATION | NSM-9 | 2026-03-18 | Acceptable | 2026-03-18 |