Management of Intracerebral Hemorrhage With Aminocaproic Acid - Pilot Study

NCT ID: NCT02639819

Last Updated: 2017-07-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2017-12-31

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.

Conditions

Intracerebral Hemorrhage

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Study drug

Group Type: EXPERIMENTAL

ɛ-Aminocaproic Acid

Intervention Type: DRUG

Intervention: intravenous ε-Aminocaproic Acid within 3 hours of symptom onset

Interventions

ɛ-Aminocaproic Acid

Intervention: intravenous ε-Aminocaproic Acid within 3 hours of symptom onset

Intervention Type: DRUG

Other Intervention Names

Amicar; Aminocaproic Acid

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vivek Misra, MD

Role: STUDY_CHAIR

The University of Texas Health Science Center at San Antonio

Jean-Louis Caron, MD, FRCS(C)

Role: STUDY_DIRECTOR

The University of Texas Health Science Center at San Antonio

Reza Behrouz, DO

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Other Identifiers

HSC20160096H

Identifier Type: -

Identifier Source: org_study_id