Descrizione riassuntiva della sperimentazione (Fonte di dati: BASEC)
Bei einer Hirnblutung kommt es zu permanenten Schäden im Gehirn, welche eine bleibende (schwere) Behinderung nach sich ziehen können. Mit der Zeit kann die Blutung auch zunehmen, was bedeutet, dass der Grad der Behinderung grösser werden oder dies gar zum Tod führen kann. Zum jetzigen Zeitpunkt gibt es keine medizinische oder chirurgische Behandlung, welche erwiesenermaßen eine Blutung im Gehirn stoppen und zur Verbesserung der Symptome führen kann. In dieser Studie testen wir, ob es möglich ist, Patienten mit einer Hirnblutung innerhalb der ersten Stunden nach Symptombeginn mit einem Medikament – Tranexamsäure – zu behandeln. Wir möchten zeigen, dass eine Behandlung mit diesem Medikament die Chancen zu sterben oder mit einer schweren Behinderung zu leben reduziert.
Die Studienmedikation ist eine Substanz, welche dazu führt, dass das Blut verklumpt und eine Blutung gestoppt wird. Dieses Medikament wird nicht in der Routine zur Behandlung einer Hirnblutung eingesetz. Tranexamsäure ist ein etabliertes Medikament, das bereits seit Jahren für andere Erkrankungen eingesetzt wird und dort zuverlässig und schnell Blutungen stoppen kann. Um eine klare Aussage über die Wirkung von Tranexamsäure bei Patienten mit Hirnblutungen machen zu können müssen wir im Rahmen dieser Studie manchen Patienten das Medikament verabreichen und man-chen ein sogenanntes Placebo – eine gleich aussehende Lösung, welche jedoch keine Tranexamsäure enthält.
Malattie studiate(Fonte di dati: BASEC)
Hirnblutung
Health conditions
(Fonte di dati: WHO)
Stroke
Circulatory System
Intracerebral haemorrhage
Malattia rara
(Fonte di dati: BASEC)
No
Interventi esaminati (p. es. medicamento, terapia, campagna)
(Fonte di dati: BASEC)
Die Studienteilnehmer erhalten eine kurze Infusion über 10 Minuten gefolgt von einer Dauerinfusion über 8 Stunden der Studienmedikation (Tranexamsäure oder Placebo).
Interventions
(Fonte di dati: WHO)
Intravenous tranexamic acid: 1g loading dose given as 100 ml infusion over 10 minutes, followed by another 1g in 250 ml infused over 8 hours. Comparator ? matching placebo (normal saline 0.9%) administered by identical regimen.
Criteri per la partecipazione alla sperimentazione
(Fonte di dati: BASEC)
a. Intrazerebrale Blutung innerhalb von 8 Stunden nach Symptombeginn
b. Schriftliche Einverständniserkärung durch Patienten oder Angehörigen
c. >18, keine obere Alterslimite
Criteri di esclusione
(Fonte di dati: BASEC)
- Sekundäre intrazerebrale Blutung (Arterio-venöse Malformation, Aneurysma, Tomur, Sinusvenenthrombose)
- Kontraindikationen gegen Tranexamsäure (Tiefe Venenthrombose)
- Schwere vorbestehende Behinderung (modified Rankin Scale >4)
- Glasgow Coma Scale <5
- Lebenserwartung aus anderen Gründen <3 Monate (z.B. Tumor)
- Traumatische intrazerebrale Blutung
- Schwangerschaft/Stillzeit
- Andere Faktoren, welche einen Patienten in den Augen des Investigators als unpassend für die Studie qualifizieren
Inclusion/Exclusion Criteria
(Fonte di dati: WHO)
Gender: Both
Inclusion criteria: Adult (=18 years, either sex) patients with acute primary intracerebral haemorrhage (PICH) within 8 hours of stroke onset (where stroke onset time is unknown, the time of when last known well will be used)
Exclusion criteria:
1. Patients with intracerebral haemorrhage secondary to anticoagulation, thrombolysis or known underlying structural abnormality such as arterial venous malformation, aneurysm, tumour, venous thrombosis as cause for the intracerebral haemorrhage. Note it is not necessary to exclude an underlying abnormality prior to enrolment, but where a secondary cause of haemorrhage is known, these patients should not be recruited.
2. Patients for whom tranexamic acid is thought to be contraindicated
3. Patients with premorbid dependency (mRS>4)
4. Participation in another drug trial concurrently
5. Prestroke life expectancy <3 months (e.g. advanced metastatic cancer)
6. Coma ? Glasgow coma scale <5
-
Altre informazioni sulla sperimentazione
Data di registrazione della sperimentazione
17 gen 2013
Inserimento del primo partecipante
1 mar 2013
Stato di reclutamento
Completed
Titolo scientifico
(Fonte di dati: WHO)
Tranexamic acid for IntraCerebral Haemorrhage (TICH-2): a pragmatic phase III prospective double-blind randomised placebo-controlled trial
Tipo di sperimentazione
(Fonte di dati: WHO)
Interventional
Disegno della sperimentazione
(Fonte di dati: WHO)
Pragmatic phase III prospective double-blind randomised placebo-controlled trial (Treatment)
Fase
(Fonte di dati: WHO)
Phase III
Punti finali primari
(Fonte di dati: WHO)
To assess whether tranexamic acid is safe and reduces death or dependency after primary intracerebral haemorrhage (PICH)
Death or dependency (ordinal shift on mRS) at day 90 will be analysed by intention-to-treat using ordinal logistic regression (OLR), with adjustment for minimisation factors. The assumption of proportional odds will be tested using the likelihood ratio test. Comparison of tranexamic acid versus control.
Punti finali secondari
(Fonte di dati: WHO)
1. At day 7 (or discharge if sooner), neurological impairment (NIHSS)
2. At day 90, disability (Barthel index), Quality of Life (EuroQoL), cognition, cognition and mood (TICS and ZDS)
3. Safety: death, serious adverse events, thromboembolic events, seizures
4. Costs: length of stay in hospital, re-admission, institutionalisation
5. Radiological efficacy/safety (CT scan): change in haematoma volume from baseline to 24 hours, haematoma location, and new infarction
Contatto per informazioni
(Fonte di dati: WHO)
Health Technology Assessment Programme, grant ref: 11/129/109
Risultati della sperimentazione
(Fonte di dati: WHO)
Sintesi dei risultati
2016 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/27048694 protocol
2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29431141 sub-study protocol
2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29778325 results
2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31322116 results (added 22/07/2019)
2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31735141 CT results in (added 19/11/2019)
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/32902808/ results (added 11/09/2020)
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33586453/ results (added 16/02/2021)
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34000834/ (added 19/05/2021)
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35311937/ Substudy results (added 22/03/2022)
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37337529/ Secondary analysis (added 20/06/2023)
Collegamento ai risultati nel registro primario
ancora nessuna informazione disponibile
Informazioni sulla disponibilità dei dati dei singoli partecipanti
Data sharing statement to be made available at a later date
1. The study protocol for the main study is available at: http://tich-2.org/ShWrtq5IdxUu8LdpTzMfD2U3Uh4.php
2. The statistical analysis plan and the protocol for the MRI sub-study have both been submitted for publication
3. A publication will be drafted in mid-March 2018 following the primary data analysis
4. Dissemination of the results will be via an oral presentation at the European stroke conference and publication in either NEJM or Lancet is planned for May 2018
Siti di esecuzione della sperimentazione
Siti di esecuzione in Svizzera
(Fonte di dati: BASEC)
Basilea
Paesi di esecuzione
(Fonte di dati: WHO)
Denmark, England, Georgia, Hungary, Ireland, Italy, Malaysia, Poland, Spain, Sweden, Switzerland, Turkey, United Kingdom
Contatto per maggiori informazioni sulla sperimentazione
Dati della persona di contatto in Svizzera
(Fonte di dati: BASEC)
Seiffge David
061-3287278
david.seiffge@usb.ch
Contatto per informazioni scientifiche
(Fonte di dati: WHO)
Nikola
Sprigg
Stroke, Division of Clinical Neuroscience Clinical Sciences Building City Hospital Hucknall Road
-
nikola.sprigg@nottingham.ac.uk
Autorizzazione da parte della commissione d’etica (Fonte di dati: BASEC)
Nome della commissione d’etica che rilascia l’autorizzazione (nel caso di studi multicentrici solo la commissione direttiva)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
Altri numeri di identificazione delle sperimentazioni
Secondary ID (Fonte di dati: WHO)
2012-004108-37
Nil known
HTA 11/129/109
13467
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