MedDataX Logo

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

NCT ID: NCT02323685

Last Updated: 2016-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Safety and effect of SANGUINATE on patients DCI following SAH.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Cerebral Ischemia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

DCI Delayed Cerebral Ischemia SAH Subarachnoid Hemorrhage Aneurysmal Subarachnoid Hemorrhage Cerebral Ischemia Brain Ischemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SANGUINATE™

Single infusion of SANGUINATE (pegylated carboxyhemogloblin)

Group Type EXPERIMENTAL

SANGUINATE™

Intervention Type BIOLOGICAL

Single infusion of SANGUINATE (pegylated carboxyhemogloblin)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SANGUINATE™

Single infusion of SANGUINATE (pegylated carboxyhemogloblin)

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Prolong Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael N Dirringer, MD

Role: STUDY_CHAIR

Barnes Jewish Hospital/Washington University

Rajat Dhar, MD

Role: PRINCIPAL_INVESTIGATOR

Barnes Jewish Hospital/Washington University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Barnes Jewish Hospital/Washington University

St Louis, Missouri, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SGCI-002

Identifier Type: -

Identifier Source: org_study_id