Tranexamic Acid for Acute ICH Growth prEdicted by Spot Sign

Conditions

Intracerebral Hemorrhage, Stroke

Keywords

Intracerebral Hemorrhage, tranexamic acid, spot sign

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.

Fan Fu, Shengjun Sun, Liping Liu, Hongqiu Gu, Yaping Su et al. (6 authors)

Stroke2018-09-0124 citations

10.1161/strokeaha.118.022017

Prevention of haematoma progression by tranexamic acid in intracerebral haemorrhage patients with and without spot sign on admission scan: a statistical analysis plan of a pre-specified sub-study of the TICH-2 trial.

Ovesen C, Jakobsen JC, Gluud C, Steiner T, Law Z, Flaherty K, Dineen RA, Bath PM, Sprigg N, Christensen H.

2018-06-137 citations

10.1186/s13104-018-3481-8

Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage (TICH-2): an international randomised, placebo-controlled, phase 3 superiority trial.

Sprigg N, Flaherty K, Appleton JP, Al-Shahi Salman R, Bereczki D, Beridze M, Christensen H, Ciccone A, Collins R, Czlonkowska A, Dineen RA, Duley L, Egea-Guerrero JJ, England TJ, Krishnan K, Laska AC, Law ZK, Ozturk S, Pocock SJ, Roberts I, Robinson TG, Roffe C, Seiffge D, Scutt P, Thanabalan J, Werring D, Whynes D, Bath PM, TICH-2 Investigators.

2018-05-16323 citations

10.1016/s0140-6736(18)31033-x

Interventions

DRUGTranexamic Acid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
hemorrhage growth	24±2 hours	either \>33% or \>6 ml increase from baseline, adjusted for baseline ICH volume

Secondary

Measure	Time frame	Description
Major thromboembolic events	30±4 days	(1) acute myocardial ischemia; (2) acute cerebral ischemia; and (3) acute pulmonary embolism
Poor clinical outcome	90±7 days	The Number of patients that is Death or major disability(mRS 4-6)
short-term outcome	30±4 days	The Number of patients that with Modified Rankin Scale (mRS) 0-2 at 30±4 days
Other thromboembolic events	90±7 days	Other thromboembolic events，such as venous thrombosis and other peripheral arterial embolism
Death due to any cause	90±7 days	Number of patients that is Death due to any cause by 90±7 days

Other

Measure	Time frame	Description
Absolute ICH growth volume	24±2 hours	The absolute ICH growth volume compared with the baseline CT scan
Absolute IVH growth volume	24±2 hours	The absolute IVH growth volume compared with the baseline CT scan

Countries

China

Contacts

Primary ContactLiping Liu, MD

lipingsister@gmail.com8610-67098368

Outcome results

None listed