Overview

Tranexamic Acid for Acute ICH Growth prEdicted by Spot Sign

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ministry of Science and Technology of the People´s Republic of China
Collaborator:
Beijing Municipal Science & Technology Commission
Treatments:
Tranexamic Acid
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