Management of Intracerebral Hemorrhage With Aminocaproic Acid - Pilot Study

Intracerebral Hemorrhage Clinical Trial

— MANICHAN-PILOT  

Official title:

A Pilot Study of Ultra-Early Intravenous ɛ-Aminocaproic Acid in Spontanteous Intracerebral Hemorrhage

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02639819
• Other study ID #: HSC20160096H
• Status: Withdrawn
• Phase: Phase 1
• First received: December 18, 2015
• Last updated: July 5, 2017
• Start date: June 2016
• Est. completion date: December 2017

Study information

• Verified date: July 2017
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Intervention

Drug:
• ?-Aminocaproic Acid
Intervention: intravenous e-Aminocaproic Acid within 3 hours of symptom onset

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematoma volume		24 hours
Primary	Lower extermity deep vein thrombosis on venous duplex ultrasound		24-48 hours
Primary	Evidence of cardiac ischemia on the electrocardiogram		24 hours
Primary	National Insitutes of Health Stroke Scale score		24 hours
Secondary	Modified Rankin Scale score		30 Days