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Tranexamic Acid for Acute ICH Growth prEdicted by Spot Sign (TRAIGE)

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ClinicalTrials.gov Identifier: NCT02625948
Recruitment Status : Unknown
Verified September 2016 by Liping Liu, Ministry of Science and Technology of the People´s Republic of China.
Recruitment status was:  Recruiting
First Posted : December 9, 2015
Last Update Posted : September 14, 2016
Sponsor:
Collaborator:
Beijing Municipal Science & Technology Commission
Information provided by (Responsible Party):
Liping Liu, Ministry of Science and Technology of the People´s Republic of China

Study Description
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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

Condition or disease Intervention/treatment Phase
Intracerebral Hemorrhage Stroke Drug: Tranexamic Acid Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2015
Estimated Primary Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: tranexamic acid
tranexamic acid
 Drug: Tranexamic Acid
Placebo Comparator: Placebo
0.9% NaCl
 Drug: Tranexamic Acid
No Intervention: observation(spot sign -)
regular clinical treatment


Outcome Measures
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Primary Outcome Measures :
  1. hemorrhage growth [ Time Frame: 24±2 hours ]
    either >33% or >6 ml increase from baseline, adjusted for baseline ICH volume


Secondary Outcome Measures :
  1. Major thromboembolic events [ Time Frame: 30±4 days ]
    (1) acute myocardial ischemia; (2) acute cerebral ischemia; and (3) acute pulmonary embolism

  2. Poor clinical outcome [ Time Frame: 90±7 days ]
    The Number of patients that is Death or major disability(mRS 4-6)

  3. short-term outcome [ Time Frame: 30±4 days ]
    The Number of patients that with Modified Rankin Scale (mRS) 0-2 at 30±4 days

  4. Other thromboembolic events [ Time Frame: 90±7 days ]
    Other thromboembolic events，such as venous thrombosis and other peripheral arterial embolism

  5. Death due to any cause [ Time Frame: 90±7 days ]
    Number of patients that is Death due to any cause by 90±7 days


Other Outcome Measures:
  1. Absolute ICH growth volume [ Time Frame: 24±2 hours ]
    The absolute ICH growth volume compared with the baseline CT scan

  2. Absolute IVH growth volume [ Time Frame: 24±2 hours ]
    The absolute IVH growth volume compared with the baseline CT scan


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02625948


Contacts
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Contact: Liping Liu, MD 8610-67098368 lipingsister@gmail.com

Locations
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China, Beijing
Aviation General Hospital Not yet recruiting
Beijing, Beijing, China, 100050
Beijing Fangshan District Liangxiang Hospital Recruiting
Beijing, Beijing, China, 100050
Beijing Friendship Hospital Recruiting
Beijing, Beijing, China, 100050
Beijing Haidian hospital Recruiting
Beijing, Beijing, China, 100050
Beijing Huairou District Hospital Not yet recruiting
Beijing, Beijing, China, 100050
Beijing Shunyi Hospital Recruiting
Beijing, Beijing, China, 100050
Beijing Tian Tan Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100050
Contact: Liping Liu, MD    8610-67098368      
Peking University Third Hospital Recruiting
Beijing, Beijing, China, 100050
China, Hebei
Kailuan general hospital Recruiting
Tangshan, Hebei, China, 063000
Tangshan gongren hospital Recruiting
Tangshan, Hebei, China, 063000
Tangshan people's hospital Recruiting
Tangshan, Hebei, China, 063000
Sponsors and Collaborators
Ministry of Science and Technology of the People´s Republic of China
Beijing Municipal Science & Technology Commission
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: 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
ClinicalTrials.gov Identifier: NCT02625948    
Other Study ID Numbers: D141100000114002
First Posted: December 9, 2015    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016
Keywords provided by Liping Liu, Ministry of Science and Technology of the People´s Republic of China:
Intracerebral Hemorrhage
tranexamic acid
spot sign
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Vascular Diseases
Cardiovascular Diseases
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants