Cerebral IschemiaPhase 2NCT02323685
Safety and Effect of SANGUINATE™ Infusion in Patients at Risk of Delayed Cerebral Ischemia (DCI) Following Subarachnoid Hemorrhage (SAH)
A Phase 2 study testing SANGUINATE™ in people with Cerebral Ischemia, run by Prolong Pharmaceuticals at 1 site in United States.
Trial summary
Safety and effect of SANGUINATE on patients DCI following SAH. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cerebral Ischemia
- What is being tested?
- SANGUINATE™
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Oct 2016
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated written informed consent by the subject or his/her legally authorized representative;
- Modified Rankin (mRankin) score of 0 or 1 prior to the onset of subarachnoid hemorrhage;
- Ruptured aneurysm secured by endovascular coil embolization or surgical clipping (the Procedure), not more than 72 hours after the onset of subarachnoid hemorrhage; and
- Hunt and Hess (H\&H) grade 3 or 4, or World Federation of Neurological Surgeons (WFNS) score 3 or 4 prior to the Procedure, and Modified Fisher (mFisher) grade 3 or 4, prior to the Procedure; or
- Clinical signs of ("symptomatic") delayed cerebral ischemia; or
- Angiographic evidence of cerebral vasospasm
Who cannot join
- In the judgment of the Investigator the patient is not a good candidate for the study
- Evidence of rebleed following the Procedure
- Subarachnoid hemorrhage secondary to trauma or to arteriovenous malformation
- Diagnosed moderate to severe pulmonary hypertension
- Radiologically confirmed moderate to severe pulmonary edema (as shown by the presence of Kerley lines, peribronchial cuffing, thickened interlobar fissure, consolidation and/or pleural effusion)
- History within the past 6 months and/or finding of decompensated heart failure
Show all 9Show fewer
- Acute myocardial infarction within 3 months prior to the administration of the study drug
- Left ventricular ejection fraction <40%, as determined by prior echocardiography or clinical signs of CHF
- Medical history or concurrent evidence of moderate to severe renal insufficiency (estimated creatinine clearance < 30 mL/min)
Trial locations and contacts
1 site in 1 country.
United States1 site
Barnes Jewish Hospital/Washington University
St Louis, Missouri, 63110
About this study
Official title: Single Escalating-dose, Open-label Study to Assess the Safety and Effect of SANGUINATE™ Infusion in Patients at Risk of Delayed Cerebral Ischemia (DCI) After Acute Aneurysmal Subarachnoid Hemorrhage (SAH)
Safety and effect of SANGUINATE on patients DCI following SAH.
Read the detailed description
The purpose of this study is to study the safety and effect of SANGUINATE on patients suffering from delayed cerebral ischemia after acute aneurysmal subarachnoid hemorrhage.
- Conditions
- Cerebral Ischemia
- Being tested
- SANGUINATE™
- Keywords
- DCI, Delayed Cerebral Ischemia, SAH, Subarachnoid Hemorrhage, Aneurysmal Subarachnoid Hemorrhage, Cerebral Ischemia, Brain Ischemia
- Medical subject headings
- Brain Ischemia, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SANGUINATE™Biological
Single infusion of SANGUINATE (pegylated carboxyhemogloblin)
| Study group | Role | What they receive |
|---|---|---|
| SANGUINATE™ | Experimental | Single infusion of SANGUINATE (pegylated carboxyhemogloblin) Receives: Biological: SANGUINATE™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of study drug during and following infusion as measured by vital signs, clinical signs, bioanalytical measures, or investigational drug-related adverse events
Safety assessments to include vital signs, clinical signs, bioanalytical measures, or investigational drug-related adverse events
Measured: Up to 30 days
Impact of SANGUINATE on brain oxygenation and blood flow assessed using Postitron Emission Tomography (PET)
Blood oxygenation and blood flow will be assessed using Postitron Emission Tomography (PET)
Measured: Up to 30 days
Secondary outcomes (3)
Changes in neurological function measured by National Institutes of Health Stroke Scale (NIHSS)
Measured: Up to 30 days
Incidence, location, and size of cerebral infarction as measured by MRI
Measured: Up to 30 days
Changes in Blood Gases as measured by Hemoximetry
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionJun 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral IschemiaStudies of the same condition, open and under way.
- 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 2
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prolong Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael N Dirringer, MD, Study chair, Barnes Jewish Hospital/Washington UniversityRajat Dhar, MD, Principal investigator, Barnes Jewish Hospital/Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02323685
- Sponsor's protocol ID
- SGCI-002
- Status last verified
- Oct 2016
- First submitted
- 12 Nov 2014
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Escalating-dose, Open-label Study to Assess the Safety and Effect of SANGUINATE™ Infusion in Patients at Risk of Delayed Cerebral Ischemia (DCI) After Acute Aneurysmal Subarachnoid Hemorrhage (SAH)
- ClinicalTrials.gov ID
- NCT02323685
- Acronym / sponsor ID
- SGCI-002
- Conditions
- Cerebral Ischemia
- Keywords
- DCI, Delayed Cerebral Ischemia, SAH, Subarachnoid Hemorrhage, Aneurysmal Subarachnoid Hemorrhage, Cerebral Ischemia, Brain Ischemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Prolong PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 23 Dec 2014 (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.
Safety and effect of SANGUINATE on patients DCI following SAH.
Detailed description
The purpose of this study is to study the safety and effect of SANGUINATE on patients suffering from delayed cerebral ischemia after acute aneurysmal subarachnoid hemorrhage.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SANGUINATE™ | Experimental | Biological: SANGUINATE™Single infusion of SANGUINATE (pegylated carboxyhemogloblin) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed and dated written informed consent by the subject or his/her legally authorized representative;
- Modified Rankin (mRankin) score of 0 or 1 prior to the onset of subarachnoid hemorrhage;
- Ruptured aneurysm secured by endovascular coil embolization or surgical clipping (the Procedure), not more than 72 hours after the onset of subarachnoid hemorrhage; and
- Hunt and Hess (H\&H) grade 3 or 4, or World Federation of Neurological Surgeons (WFNS) score 3 or 4 prior to the Procedure, and Modified Fisher (mFisher) grade 3 or 4, prior to the Procedure; or
- Clinical signs of ("symptomatic") delayed cerebral ischemia; or
Key exclusion criteria (9 listed)
- In the judgment of the Investigator the patient is not a good candidate for the study
- Evidence of rebleed following the Procedure
- Subarachnoid hemorrhage secondary to trauma or to arteriovenous malformation
- Diagnosed moderate to severe pulmonary hypertension
- Radiologically confirmed moderate to severe pulmonary edema (as shown by the presence of Kerley lines, peribronchial cuffing, thickened interlobar fissure, consolidation and/or pleural effusion)
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 |
|---|---|---|
| SANGUINATE™Single infusion of SANGUINATE (pegylated carboxyhemogloblin) | Biological | SANGUINATE™ |
Primary outcome
Safety of study drug during and following infusion as measured by vital signs, clinical signs, bioanalytical measures, or investigational drug-related adverse events
Time frame: Up to 30 days
Safety assessments to include vital signs, clinical signs, bioanalytical measures, or investigational drug-related adverse events
Impact of SANGUINATE on brain oxygenation and blood flow assessed using Postitron Emission Tomography (PET)
Time frame: Up to 30 days
Blood oxygenation and blood flow will be assessed using Postitron Emission Tomography (PET)
3 secondary outcomes
Changes in neurological function measured by National Institutes of Health Stroke Scale (NIHSS)
Time frame: Up to 30 days
Incidence, location, and size of cerebral infarction as measured by MRI
Time frame: Up to 30 days
Changes in Blood Gases as measured by Hemoximetry
Time frame: Up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
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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.
Michael N Dirringer, MD study chair
Barnes Jewish Hospital/Washington University
Rajat Dhar, MD principal investigator
Barnes Jewish Hospital/Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SANGUINATE™ in people with Cerebral Ischemia, run by Prolong Pharmaceuticals at 1 site in United States.
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 6 inclusion and 9 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: finished, as of the sponsor's last update on 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety of study drug during and following infusion as measured by vital signs, clinical signs, bioanalytical measures, or investigational drug-related adverse events (time frame: Up to 30 days). The study lists 2 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 27 Oct 2016.