Liu 2017 (TRAIGE).

Trial name or title	Tranexamic Acid for Acute ICH Growth prEdicted by Spot Sign (TRAIGE)
Methods	The purpose of this study is to determine if CTA can predict which individuals with ICH will experience significant growth in the size of the haemorrhage. For individuals who are at high risk for haemorrhage growth, the study will compare the drug tranexamic acid to placebo to determine the effect and safety on ICH
Participants	Inclusion criteria People presenting with an acute spontaneous hypertensive ICH CTA evaluation can be accomplished within 6 h of symptom onset, with 'spot sign' positive in CTA original image Age range from 18 to 79 years Randomisation can be finished and treatment can commence within 8 h of symptom onset Informed consent has been received in accordance with local ethics committee requirements Exclusion Criteria: ICH known or suspected to be secondary to tumour, vascular malformation, aneurysm, or trauma Infratentorial ICH GCS total score < 8 ICH volume > 70 mL Parenchymal haemorrhage with ventricle involved, blood completely fills one lateral ventricle or more than half of both lateral ventricles Contraindication of CTA imaging (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 6 months, including clinical, ECG, laboratory, or imaging findings. Clinically silent chance findings of old ischaemia are not considered exclusion criteria. Planned surgery for ICH Pregnancy, within 30 days after delivery, or during lactation Use of heparin, low‐molecular weight heparin, or oral anticoagulation within the previous 1 week, with abnormal laboratory values Known allergy to tranexamic acid Prestroke modified mRS score of > 2
Interventions	Intervention: tranexamic acid Comparator: 0.9% normal saline placebo
Outcomes	Primary outcome measures haemorrhage growth (time frame: 24 ± 2 h) either > 33%, or > 6 mL increase from baseline, adjusted for baseline ICH volume Secondary outcome measures Major thromboembolic events (time frame: 30 ± 4 days; acute MI, acute cerebral ischaemia, acute PE) Poor clinical outcome (time frame: 90 ± 7 days): the number of participants who died or have major disability (mRS 4 to 6) Short‐term outcome: the number of participants with mRS 0 to 2 at 30 ± 4 days Other thromboembolic events (time frame: 90 ± 7 days): other thromboembolic events, such as venous thrombosis and other peripheral arterial embolism Death due to any cause: number of patients that died due to any cause by 90 ± 7 days
Starting date	September 2015
Contact information	Liping Liu, Professor of Neurology and Stroke Center, Beijing Tiantan Hospital, Capital Medical University, Ministry of Science and Technology of the People's Republic of China
Notes	NCT02625948