STOP-AUST: The Spot Sign and Tranexamic Acid On Preventing ICH Growth - AUStralasia Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by National Stroke Research Institute, Australia
Sponsor:
Information provided by (Responsible Party):
National Stroke Research Institute, Australia
ClinicalTrials.gov Identifier:
NCT01702636
First received: October 3, 2012
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

The aim of the study is to test if intracerebral haemorrhage (ICH) patients who have contrast extravasation on computed tomography angiography, the "spot sign", have lower rates of haematoma growth when treated with tranexamic acid within 4.5 hours of stroke onset, compared to placebo.


Condition Intervention Phase
Intracerebral Haemorrhage
Stroke
Drug: Tranexamic Acid
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: STOP-AUST: The Spot Sign and Tranexamic Acid On Preventing ICH Growth - AUStralasia Trial.

Resource links provided by NLM:


Further study details as provided by National Stroke Research Institute, Australia:

Primary Outcome Measures:
  • ICH growth by 24±3 hours as defined by either 33% or 6 ml increase from baseline, adjusted for baseline ICH volume. [ Time Frame: 24+/-3 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Major thromboembolic events (myocardial infarction, ischaemic stroke, pulmonary embolism) [ Time Frame: Within 90+/-7 days ] [ Designated as safety issue: Yes ]
  • Absolute ICH growth volume by 24±3 hours, adjusted for baseline ICH volume [ Time Frame: 24+/-3 hours ] [ Designated as safety issue: No ]
  • Absolute intraventricular haematoma (IVH) growth volume by 24±3 hours, adjusted for baseline IVH volume [ Time Frame: 24+/-3 hours ] [ Designated as safety issue: No ]
  • modified Rankin Scale (mRS) score of 0-4 at 3 months [ Time Frame: 90+/-7 days ] [ Designated as safety issue: No ]
  • modified Rankin Scale (mRS) score of 0-3 at 3 months [ Time Frame: 90+/-7 days ] [ Designated as safety issue: No ]
  • Categorical shift in mRS at 3 months, subject to the validity of proportional odds assumption [ Time Frame: 90+/-7 days ] [ Designated as safety issue: No ]
  • Death due to any cause by 3 months [ Time Frame: within 90+/-7 days ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • ICH growth [ Time Frame: 24+/-3 hours ] [ Designated as safety issue: No ]
    Exploratory analyses will be run with adjustments for baseline variables such as age, Glasgow Coma Scale (GCS), presence of IVH, and ICH location, and in the following subgroups: onset-to-treatment time (<3 vs. >3 hours); baseline ICH volume (<30 vs. >30 ml); anatomical location (deep, lobar, or cerebellar); IVH (absent vs. present); GCS (>12 vs. 8-12) and age (<70 vs. >70). These analyses will be hypothesis generating, as the trial is not powered for them.

  • modified Rankin Scale (mRS) [ Time Frame: 90+/-7 days ] [ Designated as safety issue: No ]
    Exploratory analyses will be run with adjustments for baseline variables such as age, Glasgow Coma Scale (GCS), presence of IVH, and ICH location, and in the following subgroups: onset-to-treatment time (<3 vs. >3 hours); baseline ICH volume (<30 vs. >30 ml); anatomical location (deep, lobar, or cerebellar); IVH (absent vs. present); GCS (>12 vs. 8-12) and age (<70 vs. >70). These analyses will be hypothesis generating, as the trial is not powered for them.


Estimated Enrollment: 100
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: Placebo
Intravenous placebo in 100 mL 0.9% NaCl over 10 minutes followed by 500 mL 0.9% NaCl infusion over 8 hours.
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients presenting with an acute ICH
  • Contrast extravasation within the haemorrhage, "spot sign", evaluated from the CTA according to three criteria, all of which must be present:

    1. Serpiginous or spot-like appearance within the margin of a parenchymal haematoma without connection to an outside vessel;
    2. The density (in Hounsfield units) should be greater than that of the background haematoma (site investigators are not required to document the density); and
    3. No hyperdensity at the corresponding location on non-contrast CT.
  • Age ≥18 years
  • Treatment can commence within 1 hour of initial CT and within 4.5 hours of symptom onset (or in patients with unknown time of symptom onset, the time patient was last known to be well)
  • Informed consent has been received in accordance to local ethics committee requirements

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, tumor, or infection
  • Contrast already administered within 24 hours prior to initial CT or contraindication to imaging with CT contrast agents (e.g. known or suspected iodine allergy or significant renal failure)
  • 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.
  • Pre-stroke modified Rankin Scale (mRS) score of >2
  • 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01702636

Contacts
Contact: Atte Meretoja, MD +61 3 9342 8443 atte.meretoja@unimelb.edu.au

Locations
Australia, New South Wales
Gosford Hospital Not yet recruiting
Kanwal, New South Wales, Australia, 2259
Principal Investigator: Jonathan Sturm, MD         
John Hunter Hospital Recruiting
Newcastle, New South Wales, Australia, 2310
Principal Investigator: Neil Spratt         
St. Vincent's Hospital Not yet recruiting
Sydney, New South Wales, Australia, 2010
Principal Investigator: Romesh Markus         
Royal Prince Alfred Hospital Not yet recruiting
Sydney, New South Wales, Australia, 2050
Principal Investigator: Candice Delcourt         
Westmead Hospital Not yet recruiting
Westmead, New South Wales, Australia, 2145
Principal Investigator: Neil Mahant         
Australia, South Australia
Queen Elizabeth Hospital Not yet recruiting
Adelaide, South Australia, Australia, 5011
Principal Investigator: Jim Jannes         
Royal Adelaide Hospital Not yet recruiting
Adelaide, South Australia, Australia, 5000
Principal Investigator: Timothy Kleinig         
Lyell McEwin Hospital Not yet recruiting
Adelaide, South Australia, Australia, 5112
Principal Investigator: Timothy Kleinig         
Flinders Medical Centre Not yet recruiting
Bedford Park, South Australia, Australia, 5042
Principal Investigator: Andrew Lee         
Australia, Victoria
Box Hill Hospital Recruiting
Box Hill, Victoria, Australia, 3128
Principal Investigator: Christopher Bladin         
Northern Hospital Not yet recruiting
Epping, Victoria, Australia, 3076
Principal Investigator: Jorge Zavala         
Western Hospital Not yet recruiting
Footscray, Victoria, Australia, 3011
Principal Investigator: Tissa Wijeratne         
Frankston Hospital Not yet recruiting
Frankston, Victoria, Australia, 3199
Principal Investigator: Jayantha Rupasinghe         
Alfred Hospital Not yet recruiting
Melbourne, Victoria, Australia, 3004
Principal Investigator: Jorge Zavala         
The Royal Melbourne Hospital Recruiting
Melbourne, Victoria, Australia, 3050
Principal Investigator: Stephen M Davis         
Sponsors and Collaborators
National Stroke Research Institute, Australia
Investigators
Principal Investigator: Stephen M Davis, MD Melbourne Health
Principal Investigator: Geoffrey A Donnan, MD The Florey Institute of Neuroscience and Mental Health
  More Information

No publications provided by National Stroke Research Institute, Australia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Stroke Research Institute, Australia
ClinicalTrials.gov Identifier: NCT01702636     History of Changes
Other Study ID Numbers: NTA1201
Study First Received: October 3, 2012
Last Updated: March 19, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by National Stroke Research Institute, Australia:
Intracerebral Hemorrhage
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:
Hemorrhage
Stroke
Cerebral Hemorrhage
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Intracranial Hemorrhages
Antifibrinolytic Agents
Tranexamic Acid
Cardiovascular Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014