STOP-MSU: Stopping Haemorrhage With Tranexamic Acid for Hyperacute Onset Presentation Including Mobile Stroke Units
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03385928 |
|
Recruitment Status :
Recruiting
First Posted : December 29, 2017
Last Update Posted : December 5, 2019
|
Sponsor:
Neuroscience Trials Australia
Collaborator:
The Florey Institute of Neuroscience and Mental Health
Information provided by (Responsible Party):
Neuroscience Trials Australia
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
The study will be 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 ICH (intracranial haemorrhage) patients treated with intravenous tranexamic acid within 2 hours of symptom onset will have lower rates of haematoma growth than compared to placebo.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Intracerebral Haemorrhage | Drug: Tranexamic Acid Drug: Normal saline | Phase 2 |
The trial will include patients with acute spontaneous ICH, who are ≥18 years of age and are eligible for treatment within 2 hours of stroke onset. A sample size of 62 patients is calculated to give 80% power to detect a large effect size assuming mean relative ICH haematoma growth of 38% in the placebo arm compared to 19% in the active treatment arm and standard deviation of 19%, inflated for nonparametric analysis. Adaptive increase in sample size will be performed if the result of interim analysis of the first 50 patients is promising, using the methodology of Mehta and Pocock.1 The maximum sample size is capped at 124. Standard CT for initial diagnosis of suspected stroke patients will be performed. Neurological impairment and functional scores will be measured by a neurologist or health care professional trained in their administration. The assessors will be blinded to the treatment group. Patients eligible for the RCT will be randomised in a 1:1 ratio to receive either Tranexamic acid or placebo stratified by treating centre and utilising randomly permuted blocks of random size.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 62 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | The study will be 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. |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | STOP-MSU: Stopping Haemorrhage With Tranexamic Acid for Hyperacute Onset Presentation Including Mobile Stroke Units. A Phase II Randomised, Placebo-controlled, Investigator-driven Trial of Tranexamic Acid Within 2 Hours of Intracerebral Haemorrhage |
| Actual Study Start Date : | March 19, 2018 |
| Estimated Primary Completion Date : | December 1, 2020 |
| Estimated Study Completion Date : | March 1, 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
COL4A1-related brain small-vessel disease
MedlinePlus related topics:
Bleeding
Drug Information available for:
Tranexamic acid
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Tranexamic acid
Intravenous tranexamic acid 1000 mg in 100 mL 0.9% NaCl over 10 minutes followed by 1000 mg in 500 mL 0.9% NaCl infusion over 8 hours.
|
Drug: Tranexamic Acid
Investigational product given within 2 hours of symptom onset |
|
Placebo Comparator: Normal Saline (0.9% NaCl)
100 mls intravenous 0.9%NaCl over 10 minutes followed by 500 ml intravenous 0.9% NaCl infusion over 8 hours.
|
Drug: Normal saline
Placebo given within 2 hours of symptom onset
Other Name: 0.9%NaCl |
Primary Outcome Measures :
- Relative ICH haematoma growth at 24±3 hours, adjusted for baseline ICH volume (mls) [ Time Frame: 24 hours(plus or minus 3 hours) ]Relative ICH haematoma growth
Secondary Outcome Measures :
- ICH growth [ Time Frame: 24 hours (plus or minus 3 hours) ]ICH growth as defined by either 33% or 6ml increase from baseline, adjusted for baseline ICH volume
- Absolute ICH growth (mls) [ Time Frame: 24 hours (plus or minus 3 hours) ]Absolute ICH growth
- Relative ICH growth volume (mls) [ Time Frame: 1 hour after baseline CT ]Relative and absolute ICH growth volume, adjusted for baseline ICH volume
- Major thromboembolic events [ Time Frame: 3 months ]Major thromboembolic events (myocardial infarction, ischaemic stroke, pulmonary embolism) or death
- Intraventricular haematoma growth [ Time Frame: 24 hours (plus or minus 3 hours) ]Absolute intraventricular haematoma (IVH) growth volume adjusted for baseline IVH volume
- Modified Rankin Scale (mRS) [ Time Frame: 3 months ]mRS 0-4 or back to pre-stroke level, or mRS 0-3 or back to pre-stroke level (with lowest mRS score being the better outcome)
- Modified Rankin Scale (mRS) [ Time Frame: 3 months ]Categorical shift in mRS (0-6 with 6 being worst outcome)
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- Any history or current evidence suggestive of venous or arterial thrombotic events within the previous 12 months, including clinical, ECG, laboratory, or imaging findings. Clinically silent chance findings of old ischemia are not considered exclusion.
- 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 14 days, irrespective of laboratory values
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03385928
Contacts
| Contact: Henry Zhao, MD | +61 3 9342 7000 | henry.zhao@mh.org.au | |
| Contact: Michele Sallaberger | 0438 471 423 | michele.sallaberger@florey.edu.au |
Locations
| Australia, New South Wales | |
| Liverpool Hospital | Recruiting |
| Liverpool, New South Wales, Australia, 2170 | |
| Contact: Cheryl Qi Cheng +61 2 8738 7170 Qi.Cheng@health.nsw.gov.au | |
| Principal Investigator: Andrew Cheung | |
| Australia, Queensland | |
| Sunshine Coast University Hospital | Recruiting |
| Birtinya, Queensland, Australia, 4575 | |
| Contact: Karen Simmons +61 7 5202 3155 Karen.Simmons@health.qld.gov.au | |
| Principal Investigator: Rohan Grimley | |
| Princess Alexandra Hospital | Recruiting |
| Woolloongabba, Queensland, Australia, 4102 | |
| Contact: Carol Bendall +61 7 3176 5169 SRUPAH@health.qld.gov.au | |
| Principal Investigator: Darshan Shah | |
| Australia, South Australia | |
| Royal Adelaide Hospital | Recruiting |
| Adelaide, South Australia, Australia, 5000 | |
| Contact: Roy Drew Roy.Drew@sa.gov.au | |
| Principal Investigator: Timothy Kleinig | |
| Australia, Victoria | |
| Box Hill Hospital | Recruiting |
| Box Hill, Victoria, Australia, 3128 | |
| Contact: Grace Thomas +61 3 9094 9541 Grace.Thomas@monash.edu | |
| Principal Investigator: Philip Choi | |
| Monash Medical Centre | Recruiting |
| Clayton, Victoria, Australia, 3168 | |
| Contact: Veronic Hervet Marie.Hervet@monashhealth.org | |
| Principal Investigator: Henry Ma | |
| Alfred Hospital | Recruiting |
| Melbourne, Victoria, Australia, 3004 | |
| Contact: Andrea Moore +61 3 9076 3581 andrea.moore@alfred.org.au | |
| Principal Investigator: Geoffrey Cloud | |
| Royal Melbourne Hospital | Recruiting |
| Melbourne, Victoria, Australia | |
| Contact: Stephen Davis | |
| Principal Investigator: Stephen Davis | |
| New Zealand | |
| CDHB Christchurch Hospital | Recruiting |
| Christchurch, New Zealand, 8140 | |
| Contact: Jane Eagle +64 3 378 6130 Jane.Eagle@cdhb.health.nz | |
| Principal Investigator: Teddy Wu | |
| Wellington Hospital | Recruiting |
| Wellington, New Zealand, 6021 | |
| Contact: Brianne Boljonis Brianne.Boljonis@ccdhb.org.nz | |
| Principal Investigator: Anna Ranta | |
Sponsors and Collaborators
Neuroscience Trials Australia
The Florey Institute of Neuroscience and Mental Health
Investigators
| 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 |
| Responsible Party: | Neuroscience Trials Australia |
| ClinicalTrials.gov Identifier: | NCT03385928 |
| Other Study ID Numbers: |
NTA1702 |
| First Posted: | December 29, 2017 Key Record Dates |
| Last Update Posted: | December 5, 2019 |
| Last Verified: | December 2019 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Neuroscience Trials Australia:
|
ICH Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Tranexamic Acid Antifibrinolytic Agents |
Fibrin Modulating Agents Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Hematologic Agents Hemostatics Contrast Media Angiography Cerebral Angiography Tomography, X-Ray Computed |
Additional relevant MeSH terms:
|
Cerebral Hemorrhage Hemorrhage Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
Pathologic Processes Intracranial Hemorrhages Tranexamic Acid Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants |