Tranexamic Acid for Spontaneous Acute Cerebral Hemorrhage Trial

• Status: Unknown status
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to explore the effectiveness of tranexamic acid (also known as trans amine or TXA) in reducing hematoma expansion in patients with hemorrhagic stroke when given in the acute phase.

METHODOLOGY

This will be a Phase III, parallel-group double-blind randomised placebo control trial. Patients allocated to the control group will receive standard care for hemorrhagic stroke according to the 2015 American Heart Association guidelines. Patients allocated to the intervention group will receive, in addition to standard care, a loading dose of intravenous TXA 1gm within 3 hours of symptom onset followed by a 1gm maintenance dose over 8 hours. Timing and dosing are in accordance to previous established study protocols. Patients in the intervention group will only receive a single treatment course of TXA.

Study subjects will be identified by either the on-duty clinicians from the Department of Neurosurgery of this institution or by the study investigators. Should the patient meet study eligibility criteria consent will be obtained either from the patient or from his/her next of kin. 1:1 block randomization will be performed by a remote internet randomization service by accessing a website. Patients allocated to the intervention arm will have 1gm of TXA added to 100ml of normal saline (0.9%) infused over 10 minutes as a loading dose. This is then followed by a maintenance dose of 1gm of TXA in 500ml of intravenous isotonic solution infused at 120mg/hour (60ml/hour) for 8 hours. Patient's allocated to the control arm will have an equal volume of normal saline (0.9%) infused as a placebo. The patient and the outcome assessor will be blinded to study group allocation.

The primary endpoint of this study will be to assess the percentage change in brain blood clot volume by computed tomography brain scans on admission, 6 hours later, at 24 hours and at 1 week.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kwong Wah Hospital
• Treatments: Tranexamic Acid; Tranylcypromine

Criteria

Inclusion Criteria:

1. Patients with CT evidence of supratentorial intracerebral hemorrhage

2. Initiation of trial medication within 3 hours from the time of symptoms onset.

3. Ethnic Chinese

4. Reasonable expectation of completion of outcome measures at follow-up

5. Written informed consent from either the patient or next-of-kin or legal guardian.

Exclusion Criteria:

1. Patients not expected to survive 24 hours after admission.

2. Patients with brainstem herniation syndrome on admission.

3. Patients who need immediate neurosurgical intervention.

4. GCS of of 5 or less on admission i.e. a GCS score of 2 according to the Hemphil ICH score1.

5. Previous antiplatelet and anticoagulant medication use.

6. Known thrombocytopenia or coagulopathy.

7. Disseminated intravascular coagulation on admission.

8. Acute sepsis on admission.

9. Intracerebral hemorrhage (ICH) secondary to intracranial vascular lesion: aneurysm, arteriovenous malformation, neoplasm or dural venous sinus thrombosis.

10. Previous venous thromboembolic disease : deep venous thrombosis.

11. History of ischemic stroke or transient ischemic attack within 12 months.

12. History of ischemic heart disease or myocardial infarction.

13. History of peripheral vascular disease.

14. Patients with previous disability (prestroke modified Rankin scale score >2)

15. Pregnancy or breast feeding.

16. History of allergy to tranexamic acid