Clinical trial NCT02639819: Management of Intracerebral Hemorrhage With Aminocaproic Acid - Pilot Study
Official title: A Pilot Study of Ultra-Early Intravenous ɛ-Aminocaproic Acid in Spontanteous Intracerebral Hemorrhage
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Intracerebral Hemorrhage
Keywords: Intracerebral Hemorrhage
Stroke
Cerebrovascular
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2015-12-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is single-arm, open-label, safety and feasibility pilot study of ɛ-aminocaproic acid in ICH patients.

Consecutive ICH volume with hematoma volume less than 30 mL by ABC/2 method presenting within 3 hours of symptom onset, meeting all inclusion criteria, and without exclusions will be consented and enrolled. Subjects will receive 5 grams of intravenous ɛ-aminocaproic acid over 1 hour, followed by the same at 1 mg/hour for 23 hours. Comupted tomography (CT) head will be done at 24 hours in order to follow hematoma size. Electrocardiogram, lower extremity venous Doppler and NIHSS will also be done at 24 hours. The patient will be followed in the clinic 30-90 days post discharge for functional status.


Eligibility criteria: Inclusion Criteria:

1. Age 18-80 years
2. Supratentorial ICH ≤ 30 mL in volume and seen on ≥ 2 slices on a 0.5 mm CT head
3. IVH involving \< 50% of the ipsilateral lateral ventricle will be allowed
4. Treatment initiated within 1 hour of baseline CT and 3 hours of onset or last known normal

Exclusion Criteria:

1. Baseline mRS ≥ 2
2. Infratentorial hemorrhage (brainstem/cerebellum)
3. Any supratentorial hemorrhage extending to the brainstem
4. ICH \> 30 mL
5. Patients who undergo surgical evacuation
6. Presenting outside of the 3 hour window
7. Intraventricular extension \> 1/2 of one lateral ventricle
8. Intraventricular extension into the 3rd or 4th ventricle, or the aqueduct or involving \>50% of the ipsilateral lateral ventricle
9. ICH due to trauma
10. ICH due to aneurysm of arteriovenous malformation
11. ICH due to underlying neoplasm or infectious mass
12. ICH due to Warfarin or other oral or intravenous anticoagulants
13. International normalization ratio \> 1.4
14. Life expectancy \< 1 year (prior to ICH onset); due to any cause.
15. History of recent ischemic stroke (within the past 3 months)
16. History of deep vein thrombosis or pulmonary embolism
17. History of recent myocardial infarction (within the past 3 months)
18. Known history of hypercoagulable state
19. History of cancer
20. Glomerular filtration rate \< 60 mL/min
21. Received any hemostatic therapy for any indication (last 14 days)
22. Received any investigational therapy in last 90 days
23. "Do Not Resuscitate" order in place or expected, advance directives that could limit aggressive treatment measures.

Primary outcomes:
measure: Hematoma volume
timeFrame: 24 hours
measure: Lower extermity deep vein thrombosis on venous duplex ultrasound
timeFrame: 24-48 hours
measure: Evidence of cardiac ischemia on the electrocardiogram
timeFrame: 24 hours
measure: National Insitutes of Health Stroke Scale score
timeFrame: 24 hours
Secondary outcomes:
measure: Modified Rankin Scale score
timeFrame: 30 Days
Other outcomes:
Locations:
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Vivek Misra, MD
role: STUDY_CHAIR
affiliation: The University of Texas Health Science Center at San Antonio
name: Jean-Louis Caron, MD, FRCS(C)
role: STUDY_DIRECTOR
affiliation: The University of Texas Health Science Center at San Antonio
name: Reza Behrouz, DO
role: PRINCIPAL_INVESTIGATOR
References: