Back to resultsTranexamic Acid for Acute ICH Growth prEdicted by Spot Sign (TRAIGE)
Primary Purpose
Intracerebral Hemorrhage, Stroke
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tranexamic Acid
Sponsored by
About this trial
This is an interventional treatment trial for Intracerebral Hemorrhage focused on measuring Intracerebral Hemorrhage, tranexamic acid, spot sign
Eligibility Criteria
Inclusion Criteria:
Patients presenting with an acute spontaneous hypertensive Intracerebral hemorrhage
- CTA evaluation can be accomplished within 6 hours of symptom onset, with "spot sign" positive in CTA original image
- Age range from 18 to 79 years
- Randomization can be finished and treatment can commence within 8 hours of symptom onset
- Informed consent has been received in accordance to local ethics committee requirements
Exclusion Criteria:
- ICH known or suspected to be secondary to tumour, vascular malformation, aneurysm or trauma
- Infratentorial ICH
- Glasgow coma scale (GCS) total score of <8
- ICH volume >70 ml
- Parenchymal hemorrhage 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 ischemia are not considered exclusion.
- Planned surgery for ICH
- Pregnancy or 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
Sites / Locations
- Aviation General Hospital
- Beijing Fangshan District Liangxiang HospitalRecruiting
- Beijing Friendship HospitalRecruiting
- Beijing Haidian hospitalRecruiting
- Beijing Huairou District Hospital
- Beijing Shunyi HospitalRecruiting
- Beijing Tian Tan Hospital, Capital Medical UniversityRecruiting
- Peking University Third HospitalRecruiting
- Kailuan general hospitalRecruiting
- Tangshan gongren hospitalRecruiting
- Tangshan people's hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
No Intervention
Arm Label
tranexamic acid
Placebo
observation(spot sign -)
Arm Description
tranexamic acid
0.9% NaCl
regular clinical treatment
Outcomes
Primary Outcome Measures
hemorrhage growth
either >33% or >6 ml increase from baseline, adjusted for baseline ICH volume
Secondary Outcome Measures
Major thromboembolic events
(1) acute myocardial ischemia; (2) acute cerebral ischemia; and (3) acute pulmonary embolism
Poor clinical outcome
The Number of patients that is Death or major disability(mRS 4-6)
short-term outcome
The Number of patients that with Modified Rankin Scale (mRS) 0-2 at 30±4 days
Other thromboembolic events
Other thromboembolic events，such as venous thrombosis and other peripheral arterial embolism
Death due to any cause
Number of patients that is Death due to any cause by 90±7 days
Full Information
NCT ID
NCT02625948
First Posted
December 7, 2015
Last Updated
September 12, 2016
Sponsor
Ministry of Science and Technology of the People´s Republic of China
Collaborators
Beijing Municipal Science & Technology Commission
1. Study Identification
Unique Protocol Identification Number
NCT02625948
Brief Title
Tranexamic Acid for Acute ICH Growth prEdicted by Spot Sign
Acronym
TRAIGE
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Science and Technology of the People´s Republic of China
Collaborators
Beijing Municipal Science & Technology Commission
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracerebral Hemorrhage, Stroke
Keywords
Intracerebral Hemorrhage, tranexamic acid, spot sign
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
tranexamic acid
Arm Type
Active Comparator
Arm Description
tranexamic acid
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0.9% NaCl
Arm Title
observation(spot sign -)
Arm Type
No Intervention
Arm Description
regular clinical treatment
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Primary Outcome Measure Information:
Title
hemorrhage growth
Description
either >33% or >6 ml increase from baseline, adjusted for baseline ICH volume
Time Frame
24±2 hours
Secondary Outcome Measure Information:
Title
Major thromboembolic events
Description
(1) acute myocardial ischemia; (2) acute cerebral ischemia; and (3) acute pulmonary embolism
Time Frame
30±4 days
Title
Poor clinical outcome
Description
The Number of patients that is Death or major disability(mRS 4-6)
Time Frame
90±7 days
Title
short-term outcome
Description
The Number of patients that with Modified Rankin Scale (mRS) 0-2 at 30±4 days
Time Frame
30±4 days
Title
Other thromboembolic events
Description
Other thromboembolic events，such as venous thrombosis and other peripheral arterial embolism
Time Frame
90±7 days
Title
Death due to any cause
Description
Number of patients that is Death due to any cause by 90±7 days
Time Frame
90±7 days
Other Pre-specified Outcome Measures:
Title
Absolute ICH growth volume
Description
The absolute ICH growth volume compared with the baseline CT scan
Time Frame
24±2 hours
Title
Absolute IVH growth volume
Description
The absolute IVH growth volume compared with the baseline CT scan
Time Frame
24±2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients presenting with an acute spontaneous hypertensive Intracerebral hemorrhage
CTA evaluation can be accomplished within 6 hours of symptom onset, with "spot sign" positive in CTA original image
Age range from 18 to 79 years
Randomization can be finished and treatment can commence within 8 hours of symptom onset
Informed consent has been received in accordance to local ethics committee requirements
Exclusion Criteria:
ICH known or suspected to be secondary to tumour, vascular malformation, aneurysm or trauma
Infratentorial ICH
Glasgow coma scale (GCS) total score of <8
ICH volume >70 ml
Parenchymal hemorrhage 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 ischemia are not considered exclusion.
Planned surgery for ICH
Pregnancy or 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liping Liu, MD
Phone
8610-67098368
Email
lipingsister@gmail.com
Facility Information:
Facility Name
Aviation General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Beijing Fangshan District Liangxiang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Haidian hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Huairou District Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Beijing Shunyi Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Tian Tan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liping Liu, MD
Phone
8610-67098368
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Name
Kailuan general hospital
City
Tangshan
State/Province
Hebei
ZIP/Postal Code
063000
Country
China
Individual Site Status
Recruiting
Facility Name
Tangshan gongren hospital
City
Tangshan
State/Province
Hebei
ZIP/Postal Code
063000
Country
China
Individual Site Status
Recruiting
Facility Name
Tangshan people's hospital
City
Tangshan
State/Province
Hebei
ZIP/Postal Code
063000
Country
China
Individual Site Status
Recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
30354984
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.
Results Reference
derived
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Tranexamic Acid for Acute ICH Growth prEdicted by Spot Sign
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