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Trial record 31 of 195 for:    Hemorrhage AND SAH

Safety and Effect of SANGUINATE™ Infusion in Patients at Risk of Delayed Cerebral Ischemia (DCI) Following Subarachnoid Hemorrhage (SAH)

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ClinicalTrials.gov Identifier: NCT02323685
Recruitment Status : Completed
First Posted : December 23, 2014
Last Update Posted : October 27, 2016
Sponsor:
Information provided by (Responsible Party):
Prolong Pharmaceuticals

Brief Summary:
Safety and effect of SANGUINATE on patients DCI following SAH.

Condition or disease Intervention/treatment Phase
Cerebral Ischemia Biological: SANGUINATE™ Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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)
Study Start Date : December 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: SANGUINATE™
Single infusion of SANGUINATE (pegylated carboxyhemogloblin)
Biological: SANGUINATE™
Single infusion of SANGUINATE (pegylated carboxyhemogloblin)




Primary Outcome Measures :
  1. 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

  2. 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)


Secondary Outcome Measures :
  1. Changes in neurological function measured by National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: Up to 30 days ]
  2. Incidence, location, and size of cerebral infarction as measured by MRI [ Time Frame: Up to 30 days ]
  3. Changes in Blood Gases as measured by Hemoximetry [ Time Frame: Up to 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02323685


Locations
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United States, Missouri
Barnes Jewish Hospital/Washington University
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Prolong Pharmaceuticals
Investigators
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Study Chair: Michael N Dirringer, MD Barnes Jewish Hospital/Washington University
Principal Investigator: Rajat Dhar, MD Barnes Jewish Hospital/Washington University

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Responsible Party: Prolong Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02323685     History of Changes
Other Study ID Numbers: SGCI-002
First Posted: December 23, 2014    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016
Keywords provided by Prolong Pharmaceuticals:
DCI
Delayed Cerebral Ischemia
SAH
Subarachnoid Hemorrhage
Aneurysmal Subarachnoid Hemorrhage
Cerebral Ischemia
Brain Ischemia
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Hemorrhage
Intracranial Hemorrhages
Brain Ischemia
Cerebral Infarction
Ischemia
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Stroke