drugset / Trial / NCT03385928
STOP-MSU: Stopping Haemorrhage With Tranexamic Acid for Hyperacute Onset Presentation Including Mobile Stroke Units
Phase 2
Completed
201 enrolled
Neuroscience Trials Australia
The Florey Institute of Neuroscience and Mental Health · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The study is a prospective phase II randomised, double-blind, placebo-controlled investigator-driven trial in acute intracerebral haemorrhage patients. The study has 2 arms with 1:1 randomisation to either intravenous tranexamic acid or placebo and will test the hypothesis that in patients with spontaneous ICH, treatment with tranexamic acid within 2 hours of onset will reduce haematoma expansion compared to placebo.
Timeline
- Start
- 2018-03-19
- Primary completion
- 2023-05-28
- Completion
- 2023-05-28
Publications
- Yassi N, Zhao H, Churilov L, Wu TY, Ma H, Nguyen HT, Cheung A, Meretoja A, Mai DT, Kleinig T, Jeng JS, Choi PMC, Duc PD, Brown H, Ranta A, Spratt N, Cloud GC, Wang HK, Grimley R, Mahawish K, Cho DY, Shah D, Nguyen TMP, Sharma G, Yogendrakumar V, Yan B, Harrison EL, Devlin M, Cordato D, Martinez-Majander N, Strbian D, Thijs V, Sanders LM, Anderson D, Parsons MW, Campbell BCV, Donnan GA, Davis SM; STOP-MSU Trial Investigators. Tranexamic acid versus placebo in individuals with intracerebral haemorrhage treated within 2 h of symptom onset (STOP-MSU): an international, double-blind, randomised, phase 2 trial. Lancet Neurol. 2024 Jun;23(6):577-587. doi: 10.1016/S1474-4422(24)00128-5. Epub 2024 Apr 20.
- Eilertsen H, Menon CS, Law ZK, Chen C, Bath PM, Steiner T, Desborough MJ, Sandset EC, Sprigg N, Al-Shahi Salman R. Haemostatic therapies for stroke due to acute, spontaneous intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD005951. doi: 10.1002/14651858.CD005951.pub5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Tranexamic Acid | Small molecule | 1000 mg | Intravenous |