Tranexamic Acid for Acute ICH Growth prEdicted by Spot Sign

Stroke Clinical Trial

— TRAIGE  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02625948
• Other study ID #: D141100000114002
• Status: Recruiting
• Phase: Phase 2
• First received: December 7, 2015
• Last updated: September 12, 2016
• Start date: September 2015

Study information

• Verified date: September 2016
• Source: Ministry of Science and Technology of the People´s Republic of China
• Contact: Liping Liu, MD
• Phone: 8610-67098368
• Email: lipingsister[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage
• Stroke

Intervention

Drug:
• Tranexamic Acid

Locations

Country	Name	City	State
China	Aviation General Hospital	Beijing	Beijing
China	Beijing Fangshan District Liangxiang Hospital	Beijing	Beijing
China	Beijing Friendship Hospital	Beijing	Beijing
China	Beijing Haidian hospital	Beijing	Beijing
China	Beijing Huairou District Hospital	Beijing	Beijing
China	Beijing Shunyi Hospital	Beijing	Beijing
China	Beijing Tian Tan Hospital, Capital Medical University	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	Kailuan general hospital	Tangshan	Hebei
China	Tangshan gongren hospital	Tangshan	Hebei
China	Tangshan people's hospital	Tangshan	Hebei

Sponsors (2)

Lead Sponsor	Collaborator
Ministry of Science and Technology of the People´s Republic of China	Beijing Municipal Science & Technology Commission

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Absolute ICH growth volume	The absolute ICH growth volume compared with the baseline CT scan	24±2 hours	No
Other	Absolute IVH growth volume	The absolute IVH growth volume compared with the baseline CT scan	24±2 hours	No
Primary	hemorrhage growth	either >33% or >6 ml increase from baseline, adjusted for baseline ICH volume	24±2 hours	No
Secondary	Major thromboembolic events	(1) acute myocardial ischemia; (2) acute cerebral ischemia; and (3) acute pulmonary embolism	30±4 days	Yes
Secondary	Poor clinical outcome	The Number of patients that is Death or major disability(mRS 4-6)	90±7 days	No
Secondary	short-term outcome	The Number of patients that with Modified Rankin Scale (mRS) 0-2 at 30±4 days	30±4 days	No
Secondary	Other thromboembolic events	Other thromboembolic events,such as venous thrombosis and other peripheral arterial embolism	90±7 days	No
Secondary	Death due to any cause	Number of patients that is Death due to any cause by 90±7 days	90±7 days	No