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

Stroke Clinical Trial

— STOP-AUST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01702636
• Other study ID #: NTA1201
• Status: Completed
• Phase: Phase 2
• Start date: December 2012
• Est. completion date: December 2019

Study information

• Verified date: February 2020
• Source: Neuroscience Trials Australia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2019
• Est. primary completion date: August 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

• 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.

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Haemorrhage
• Stroke

Intervention

Drug:
• Tranexamic Acid

• Placebo

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	Western Hospital	Footscray	Victoria
Australia	Frankston Hospital	Frankston	Victoria
Australia	Gosford Hospital	Kanwal	New South Wales
Australia	The Royal Melbourne Hospital	Melbourne	Victoria
Australia	John Hunter Hospital	Newcastle	New South Wales
Australia	Royal Prince Alfred Hospital	Sydney	New South Wales
Australia	St. Vincent's Hospital	Sydney	New South Wales
Australia	Westmead Hospital	Westmead	New South Wales
Finland	Helsinki University Central Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Neuroscience Trials Australia

Countries where clinical trial is conducted

Australia,  Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ICH growth	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.	24+/-3 hours
Other	modified Rankin Scale (mRS)	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.	90+/-7 days
Primary	ICH growth by 24±3 hours as defined by either 33% or 6 ml increase from baseline, adjusted for baseline ICH volume.		24+/-3 hours
Secondary	Major thromboembolic events (myocardial infarction, ischaemic stroke, pulmonary embolism)		Within 90+/-7 days
Secondary	Absolute ICH growth volume by 24±3 hours, adjusted for baseline ICH volume		24+/-3 hours
Secondary	Absolute intraventricular haematoma (IVH) growth volume by 24±3 hours, adjusted for baseline IVH volume		24+/-3 hours
Secondary	modified Rankin Scale (mRS) score of 0-4 at 3 months		90+/-7 days
Secondary	modified Rankin Scale (mRS) score of 0-3 at 3 months		90+/-7 days
Secondary	Categorical shift in mRS at 3 months, subject to the validity of proportional odds assumption		90+/-7 days
Secondary	Death due to any cause by 3 months		within 90+/-7 days