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

Phase 2

Completed

• Conditions: Stroke; Intracerebral Haemorrhage
• Interventions: Drug: Placebo; Drug: Tranexamic Acid

• Registration Number: NCT01702636
• Lead Sponsor: Neuroscience Trials Australia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-03
• Study First Submitted QC: 2012-10-04
• Study First Posted: 2012-10-08
• Study Start: 2012-12
• Primary Completion: 2019-08-14
• Study Completion: 2019-12
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Intravenous placebo in 100 mL 0.9% NaCl over 10 minutes followed by 500 mL 0.9% NaCl infusion over 8 hours.
Tranexamic Acid	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Absolute ICH growth volume by 24±3 hours, adjusted for baseline ICH volume	24+/-3 hours
Major thromboembolic events (myocardial infarction, ischaemic stroke, pulmonary embolism)	Within 90+/-7 days
Absolute intraventricular haematoma (IVH) growth volume by 24±3 hours, adjusted for baseline IVH volume	24+/-3 hours
modified Rankin Scale (mRS) score of 0-4 at 3 months	90+/-7 days
Categorical shift in mRS at 3 months, subject to the validity of proportional odds assumption	90+/-7 days
modified Rankin Scale (mRS) score of 0-3 at 3 months	90+/-7 days
Death due to any cause by 3 months	within 90+/-7 days

Trial Locations

Locations (11)

John Hunter Hospital; 🇦🇺 Newcastle, New South Wales, Australia

Frankston Hospital; 🇦🇺 Frankston, Victoria, Australia

Royal Prince Alfred Hospital; 🇦🇺 Sydney, New South Wales, Australia

Royal Adelaide Hospital; 🇦🇺 Adelaide, South Australia, Australia

Gosford Hospital; 🇦🇺 Kanwal, New South Wales, Australia

St. Vincent's Hospital; 🇦🇺 Sydney, New South Wales, Australia

Westmead Hospital; 🇦🇺 Westmead, New South Wales, Australia

Western Hospital; 🇦🇺 Footscray, Victoria, Australia

Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland

Box Hill Hospital; 🇦🇺 Box Hill, Victoria, Australia

The Royal Melbourne Hospital; 🇦🇺 Melbourne, Victoria, Australia