Intracerebral HemorrhagePhase 1MANICHAN-PILOTNCT02639819
Management of Intracerebral Hemorrhage With Aminocaproic Acid - Pilot Study
A Phase 1 study testing ɛ-Aminocaproic Acid in people with Intracerebral Hemorrhage, run by The University of Texas Health Science Center at San Antonio.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- ɛ-Aminocaproic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Dec 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
About this study
Official title: A Pilot Study of Ultra-Early Intravenous ɛ-Aminocaproic Acid in Spontanteous Intracerebral Hemorrhage
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
- Being tested
- ɛ-Aminocaproic Acid
- Keywords
- Intracerebral Hemorrhage, Stroke, Cerebrovascular
- Medical subject headings
- Cerebral Hemorrhage, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ɛ-Aminocaproic AcidDrug
Also called Amicar, Aminocaproic Acid
Intervention: intravenous ε-Aminocaproic Acid within 3 hours of symptom onset
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Study drug Receives: Drug: ɛ-Aminocaproic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematoma volume
Measured: 24 hours
Lower extermity deep vein thrombosis on venous duplex ultrasound
Measured: 24-48 hours
Evidence of cardiac ischemia on the electrocardiogram
Measured: 24 hours
National Insitutes of Health Stroke Scale score
Measured: 24 hours
Secondary outcomes (1)
Modified Rankin Scale score
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2015 (estimated)
- Study startJun 2016 (estimated)
- Primary completionJul 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: Study was withdrawn from IRB review on 03/08/16
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vivek Misra, MD, Study chair, The University of Texas Health Science Center at San AntonioJean-Louis Caron, MD, FRCS(C), Study director, The University of Texas Health Science Center at San AntonioReza Behrouz, DO, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02639819
- Sponsor's protocol ID
- HSC20160096H
- Acronym
- MANICHAN-PILOT
- Status last verified
- Jul 2017
- First submitted
- 18 Dec 2015
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Ultra-Early Intravenous ɛ-Aminocaproic Acid in Spontanteous Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT02639819
- Acronym / sponsor ID
- MANICHAN-PILOT / HSC20160096H
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Intracerebral Hemorrhage, Stroke, Cerebrovascular
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was withdrawn from IRB review on 03/08/16
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Jun 2016 (estimated)
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 24 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: ɛ-Aminocaproic AcidStudy drug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (23 listed)
- Baseline mRS ≥ 2
- Infratentorial hemorrhage (brainstem/cerebellum)
- Any supratentorial hemorrhage extending to the brainstem
- ICH > 30 mL
- Patients who undergo surgical evacuation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ɛ-Aminocaproic AcidAlso: Amicar, Aminocaproic AcidIntervention: intravenous ε-Aminocaproic Acid within 3 hours of symptom onset | Drug | Treatment |
Primary outcome
Hematoma volume
Time frame: 24 hours
Lower extermity deep vein thrombosis on venous duplex ultrasound
Time frame: 24-48 hours
Evidence of cardiac ischemia on the electrocardiogram
Time frame: 24 hours
National Insitutes of Health Stroke Scale score
Time frame: 24 hours
1 secondary outcome
Modified Rankin Scale score
Time frame: 30 Days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivek Misra, MD study chair
The University of Texas Health Science Center at San Antonio
Jean-Louis Caron, MD, FRCS(C) study director
The University of Texas Health Science Center at San Antonio
Reza Behrouz, DO principal investigator
The University of Texas Health Science Center at San Antonio
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ɛ-Aminocaproic Acid in people with Intracerebral Hemorrhage, run by The University of Texas Health Science Center at San Antonio.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematoma volume (time frame: 24 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.