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Management of Intracerebral Hemorrhage With Aminocaproic Acid - Pilot Study (MANICHAN-PILOT)

Primary Purpose

Intracerebral Hemorrhage

Status

Withdrawn

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

ɛ-Aminocaproic Acid

About this trial

This is an interventional treatment trial for Intracerebral Hemorrhage focused on measuring Intracerebral Hemorrhage, Stroke, Cerebrovascular

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Study drug

Outcomes

Primary Outcome Measures

Hematoma volume

Lower extermity deep vein thrombosis on venous duplex ultrasound

Evidence of cardiac ischemia on the electrocardiogram

National Insitutes of Health Stroke Scale score

Secondary Outcome Measures

Modified Rankin Scale score

Full Information

NCT ID

NCT02639819

First Posted

December 18, 2015

Last Updated

July 5, 2017

Sponsor

The University of Texas Health Science Center at San Antonio

1. Study Identification

Unique Protocol Identification Number

NCT02639819

Brief Title

Management of Intracerebral Hemorrhage With Aminocaproic Acid - Pilot Study

Acronym

MANICHAN-PILOT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Withdrawn

Why Stopped

Study was withdrawn from IRB review on 03/08/16

Study Start Date

June 2016 (Anticipated)

Primary Completion Date

July 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The University of Texas Health Science Center at San Antonio

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intracerebral Hemorrhage

Keywords

Intracerebral Hemorrhage, Stroke, Cerebrovascular

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

Study drug

Intervention Type

Drug

Intervention Name(s)

ɛ-Aminocaproic Acid

Other Intervention Name(s)

Amicar, Aminocaproic Acid

Intervention Description

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

Primary Outcome Measure Information:

Title

Hematoma volume

Time Frame

24 hours

Title

Lower extermity deep vein thrombosis on venous duplex ultrasound

Time Frame

24-48 hours

Title

Evidence of cardiac ischemia on the electrocardiogram

Time Frame

24 hours

Title

National Insitutes of Health Stroke Scale score

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Modified Rankin Scale score

Time Frame

30 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18-80 years Supratentorial ICH ≤ 30 mL in volume and seen on ≥ 2 slices on a 0.5 mm CT head IVH involving < 50% of the ipsilateral lateral ventricle will be allowed Treatment initiated within 1 hour of baseline CT and 3 hours of onset or last known normal Exclusion Criteria: Baseline mRS ≥ 2 Infratentorial hemorrhage (brainstem/cerebellum) Any supratentorial hemorrhage extending to the brainstem ICH > 30 mL Patients who undergo surgical evacuation Presenting outside of the 3 hour window Intraventricular extension > 1/2 of one lateral ventricle Intraventricular extension into the 3rd or 4th ventricle, or the aqueduct or involving >50% of the ipsilateral lateral ventricle ICH due to trauma ICH due to aneurysm of arteriovenous malformation ICH due to underlying neoplasm or infectious mass ICH due to Warfarin or other oral or intravenous anticoagulants International normalization ratio > 1.4 Life expectancy < 1 year (prior to ICH onset); due to any cause. History of recent ischemic stroke (within the past 3 months) History of deep vein thrombosis or pulmonary embolism History of recent myocardial infarction (within the past 3 months) Known history of hypercoagulable state History of cancer Glomerular filtration rate < 60 mL/min Received any hemostatic therapy for any indication (last 14 days) Received any investigational therapy in last 90 days "Do Not Resuscitate" order in place or expected, advance directives that could limit aggressive treatment measures.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vivek Misra, MD

Organizational Affiliation

The University of Texas Health Science Center at San Antonio

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Jean-Louis Caron, MD, FRCS(C)

Organizational Affiliation

The University of Texas Health Science Center at San Antonio

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Reza Behrouz, DO

Organizational Affiliation

The University of Texas Health Science Center at San Antonio

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Management of Intracerebral Hemorrhage With Aminocaproic Acid - Pilot Study

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