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

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

240

participants targeted

Target at P75+ for phase_2

Geographic Reach

1 country

11 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2015

Completed

2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2015

Completed

3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed

Last Updated

September 14, 2016

Status Verified

September 1, 2016

Enrollment Period

3.3 years

First QC Date

December 7, 2015

Last Update Submit

September 12, 2016

Conditions

Intracerebral Hemorrhage Stroke

Keywords

Intracerebral Hemorrhagetranexamic acidspot sign

Outcome Measures

Primary Outcomes (1)

hemorrhage growth
either \>33% or \>6 ml increase from baseline, adjusted for baseline ICH volume
24±2 hours

Secondary Outcomes (5)

Major thromboembolic events
30±4 days
Poor clinical outcome
90±7 days
short-term outcome
30±4 days
Other thromboembolic events
90±7 days
Death due to any cause
90±7 days

Other Outcomes (2)

Absolute ICH growth volume
24±2 hours
Absolute IVH growth volume
24±2 hours

Study Arms (3)

tranexamic acid

ACTIVE COMPARATOR

tranexamic acid

Drug: Tranexamic Acid

Placebo

PLACEBO COMPARATOR

0.9% NaCl

Drug: Tranexamic Acid

observation(spot sign -)

NO INTERVENTION

regular clinical treatment

Interventions

Tranexamic AcidDRUG

Placebotranexamic acid

Eligibility Criteria

Age18 Years - 79 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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)
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

Contact the study team to confirm eligibility.