NCT02323685

Brief Summary

Safety and effect of SANGUINATE on patients DCI following SAH.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2014

Completed
19 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 23, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

1.5 years

First QC Date

November 12, 2014

Last Update Submit

October 26, 2016

Conditions

Cerebral Ischemia

Keywords

DCIDelayed Cerebral IschemiaSAHSubarachnoid HemorrhageAneurysmal Subarachnoid HemorrhageCerebral IschemiaBrain Ischemia

Outcome Measures

Primary Outcomes (2)

  • 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

    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)

    Up to 30 days

Secondary Outcomes (3)

  • Changes in neurological function measured by National Institutes of Health Stroke Scale (NIHSS)

    Up to 30 days

  • Incidence, location, and size of cerebral infarction as measured by MRI

    Up to 30 days

  • Changes in Blood Gases as measured by Hemoximetry

    Up to 30 days

Study Arms (1)

SANGUINATE™

EXPERIMENTAL

Single infusion of SANGUINATE (pegylated carboxyhemogloblin)

Biological: SANGUINATE™

Interventions

SANGUINATE™BIOLOGICAL

Single infusion of SANGUINATE (pegylated carboxyhemogloblin)

SANGUINATE™

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barnes Jewish Hospital/Washington University

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Brain IschemiaSubarachnoid Hemorrhage

Interventions

PEGylated carboxyhemoglobin bovine

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesIntracranial HemorrhagesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michael N Dirringer, MD

    Barnes Jewish Hospital/Washington University

    STUDY CHAIR

  • Rajat Dhar, MD

    Barnes Jewish Hospital/Washington University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2014

First Posted

December 23, 2014

Study Start

December 1, 2014

Primary Completion

June 1, 2016

Study Completion

October 1, 2016

Last Updated

October 27, 2016

Record last verified: 2016-10

Locations

US(1)