STOP-MSU: Stopping Haemorrhage With Tranexamic Acid for Hyperacute Onset Presentation Including Mobile Stroke Units
1 other identifier
interventional
201
5 countries
25
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2018
Longer than P75 for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2017
CompletedFirst Posted
Study publicly available on registry
December 29, 2017
CompletedStudy Start
First participant enrolled
March 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 28, 2023
CompletedSeptember 28, 2023
September 1, 2023
5.2 years
December 13, 2017
September 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Haematoma growth by 24±6 hours as defined by either ≥33%or ≥6ml increase from baseline ICH volume (mls)
Relative ICH haematoma growth
24 hours(plus or minus 6 hours)
Secondary Outcomes (11)
Haematoma growth by 24±6 hours as defined by ≥33%or ≥6ml increase from baseline in intracerebral haematoma volume, or any increase intraventricular haematoma volume
24 hours ±6 hours
Absolute haematoma growth by 24±6 hours
24 hours ±6 hours
Relative haematoma growth by 24±6 hours
24 hour ±6 hours
Absolute intraventricular haematoma growth by 24 hours ±6 hours
24 hours ±6 hours
Absolute intracerebral plus intraventricular haematoma growth by 24±6 hours
24 hours ±6 hours
- +6 more secondary outcomes
Study Arms (2)
Tranexamic acid
ACTIVE COMPARATORIntravenous tranexamic acid 1000 mg in 100 mL 0.9% NaCl (or in 50ml syringe with 0.9% NaCl) over 10 minutes followed by 1000 mg in 500 mL 0.9% NaCl infusion over 8 hours.
Normal Saline (0.9% NaCl)
PLACEBO COMPARATOR100 mls (or in 50ml syringe) intravenous 0.9%NaCl over 10 minutes followed by 500 ml intravenous 0.9% NaCl infusion over 8 hours.
Interventions
Placebo given within 2 hours of symptom onset
Eligibility Criteria
You may qualify if:
- Patients presenting with an acute ICH
- Age ≥18 years
- Treatment can commence within 2 hours of symptom onset (or in patients with unknown time of symptom onset, the time patient was last known to be well)
- Consent can be obtained from participant or person responsible. When emergency treatment procedures have been followed the participant or person responsible will be asked for consent to continue in the study.
You may not qualify if:
- Glasgow coma scale (GCS) total score of \<8
- Brainstem ICH
- ICH volume \>70 ml as measured by the ABC/2 method
- ICH known or suspected by study investigator to be secondary to trauma, aneurysm, vascular malformation, haemorrhagic transformation of ischaemic stroke, cerebral venous thrombosis, thrombolytic therapy, tumour, or infection
- Hereditary or acquired haemorrhagic diathesis or coagulation factor deficiency.
- Use of heparin, low-molecular weight heparin, GPIIb/IIIa antagonist, or oral anticoagulation (e.g. warfarin, factor Xa inhibitor, thrombin inhibitor) within the previous 72 hours.
- Pregnancy (women of childbearing potential must be tested)
- Planned surgery for ICH within 24 hours
- Concurrent or planned treatment with haemostatic agents (e.g. prothrombin complex concentrate, vitamin K, fresh frozen plasma, or platelet transfusion)
- Participation in any investigational study in the last 30 days
- Known terminal illness or planned withdrawal of care or comfort care measures
- Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
John Hunter Hospital
New Lambton Heights, New South Wales, 2305, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, 4575, Australia
Gold Coast University Hospital
Southport, Queensland, 4215, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
St Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065, Australia
University Hospital Geelong
Geelong, Victoria, 3220, Australia
Austin Hospital
Heidelberg, Victoria, 3084, Australia
Alfred Hospital
Melbourne, Victoria, 3004, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Mobile Stroke Unit
Parkville, Victoria, 3050, Australia
Helsinki University Hospital
Helsinki, Finland
CDHB Christchurch Hospital
Christchurch, 8140, New Zealand
Palmerston North Hospital
Palmerston North, 4442, New Zealand
Wellington Hospital
Wellington, 6021, New Zealand
E-DA Hospital
Kaohsiung City, Yanchao District, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Bach Mai Hospital
Hanoi, Vietnam
Military 103 Hospital
Hanoi, Vietnam
Nguyen Tri Phuong Hospital
Ho Chi Minh City, Vietnam
Related Publications (2)
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.
PMID: 38648814DERIVEDEilertsen 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.
PMID: 37870112DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Geoffrey Donnan, MD
The Florey Institute of Neuroscience and Mental Health
- PRINCIPAL INVESTIGATOR
Stephen Davis, MD
Melbourne Health Dept of Neurology & The University of Melbourne Dept of Medicine
- PRINCIPAL INVESTIGATOR
Henry Zhao, MD
Melbourne Health Dept of Neurology & The University of Melbourne Dept of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2017
First Posted
December 29, 2017
Study Start
March 19, 2018
Primary Completion
May 28, 2023
Study Completion
May 28, 2023
Last Updated
September 28, 2023
Record last verified: 2023-09