Tranexamic Acid for Acute ICH Growth prEdicted by Spot Sign

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Intracerebral Hemorrhage Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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tranexamic acid

Group Type ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type DRUG

Placebo

0.9% NaCl

Group Type PLACEBO_COMPARATOR

Tranexamic Acid

Intervention Type DRUG

observation(spot sign -)

regular clinical treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tranexamic Acid

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Liping Liu

Professor of Neurology and Stroke Center, Beijing Tiantan Hospital, Capital Medical University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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