Clinical trial NCT02625948: Tranexamic Acid for Acute ICH Growth prEdicted by Spot Sign
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Intracerebral Hemorrhage
Stroke
Keywords: Intracerebral Hemorrhage
tranexamic acid
spot sign
Lead sponsor: Ministry of Science and Technology of the People´s Republic of China
Sponsor class: OTHER_GOV
Collaborators: name: Beijing Municipal Science & Technology Commission
First posted: 2015-12-09
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if computed tomography angiography can predict which individuals with intracerebral hemorrhage will experience significant growth in the size of the hemorrhage. For individuals who are at high risk for hemorrhage growth, the study will compare the drug Tranexamic acid to placebo to determine the effect and safety of on intracerebral hemorrhage growth

Detailed description: The Tranexamic Acid for Acute ICH Growth prEdicted by Spot Sign (TRAIGE) is a is a multicentre, randomized, placebo-controlled, double-blind, prospective, investigator-led, clinical trial of tranexamic acid within 6 hours of intracerebral hemorrhage in patients with contrast extravasation on CTA, 'the spot sign'. ICH patients within 6 hours of symptom onset, with the spot sign as a biomarker for ongoing hemorrhage, and no contraindications for antifibrinolytic therapy were enrolled in TRAIGE. The patient with a spot sign will be randomized to receive either the active treatment or placebo, the patient with no spot sign will be given regular treatment as observation. The trial is anticipated to complete in 36 months from the first subject recruitment , with 240 subjects recruited. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has been approved by IRB(Institutional Review Board) /EC(Ethics Committee) in Beijing Tiantan hospital, Capital Medical University.

Eligibility criteria: Inclusion Criteria:

Patients presenting with an acute spontaneous hypertensive Intracerebral hemorrhage

1. CTA evaluation can be accomplished within 6 hours of symptom onset, with "spot sign" positive in CTA original image
2. Age range from 18 to 79 years
3. Randomization can be finished and treatment can commence within 8 hours of symptom onset
4. Informed consent has been received in accordance to local ethics committee requirements

Exclusion Criteria:

1. ICH known or suspected to be secondary to tumour, vascular malformation, aneurysm or trauma
2. Infratentorial ICH
3. Glasgow coma scale (GCS) total score of \<8
4. ICH volume \>70 ml
5. Parenchymal hemorrhage with ventricle involved, blood completely fills one lateral ventricle or more than half of both lateral ventricles
6. Contraindication of CTA imaging (e.g. known or suspected iodine allergy or significant renal failure)
7. 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 ischemia are not considered exclusion.
8. Planned surgery for ICH
9. Pregnancy or within 30 days after delivery, or during lactation
10. Use of heparin, low-molecular weight heparin, or oral anticoagulation within the previous 1 week, with abnormal laboratory values
11. Known allergy to tranexamic acid
12. Prestroke modified mRS score of \>2

Primary outcomes:
measure: hemorrhage growth
timeFrame: 24±2 hours
Secondary outcomes:
measure: Major thromboembolic events
timeFrame: 30±4 days
measure: Poor clinical outcome
timeFrame: 90±7 days
measure: short-term outcome
timeFrame: 30±4 days
measure: Other thromboembolic events
timeFrame: 90±7 days
measure: Death due to any cause
timeFrame: 90±7 days
Other outcomes:
measure: Absolute ICH growth volume
timeFrame: 24±2 hours
measure: Absolute IVH growth volume
timeFrame: 24±2 hours
Locations:
city: Beijing
country: China
facility: Aviation General Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Fangshan District Liangxiang Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Haidian hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Huairou District Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Shunyi Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tian Tan Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Tangshan
country: China
facility: Kailuan general hospital
state: Hebei
city: Tangshan
country: China
facility: Tangshan gongren hospital
state: Hebei
city: Tangshan
country: China
facility: Tangshan people's hospital
state: Hebei
Study officials:
References:
citation: Fu F, Sun S, Liu L, Gu H, Su Y, Li Y. Iodine Sign as a Novel Predictor of Hematoma Expansion and Poor Outcomes in Primary Intracerebral Hemorrhage Patients. Stroke. 2018 Sep;49(9):2074-2080. doi: 10.1161/STROKEAHA.118.022017.