NCT01799018

Brief Summary

The purpose of this study is to determine the role of Proteomics and Metallomics in Cerebral Vasospasm following Subarachnoid Hemorrhage

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2011

Typical duration for all trials

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

Study Start

First participant enrolled

April 1, 2011

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 26, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

November 20, 2014

Status Verified

November 1, 2014

Enrollment Period

2.2 years

First QC Date

December 12, 2012

Last Update Submit

November 19, 2014

Conditions

Keywords

Xanthine OxidaseCerebrospinal fluid

Outcome Measures

Primary Outcomes (2)

  • Protein identification and concentration

    For the duration of CSF drainage, or until the 21st day after admission.

  • Metal ion identification and concentration

    For the duration of CSF drainage, or until the 21st day after admission.

Study Arms (2)

SAH Patients

Patients admitted with the diagnosis of aneurismal subarachnoid hemorrhage (SAH) and cerebral angiogram negative SAH who would need to have the external ventricular drain (EVD) placed for the management of hydrocephalus.

Control Patients

Patients with non-hemorrhagic brain pathology such as posterior fossa tumor or stroke who will have the CSF sampling for diagnostic or therapeutic purposes.

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admitted to University Hospital.

You may qualify if:

  • Non traumatic SAH documented by CT scan
  • Patient with SAH who would need external ventricular drain (EVD) for the management of hydrocephalus
  • Patients with normal pressure Hydrocephalus that require an external drain
  • Control (non - hemorrhagic) group - CSF collected from patients with posterior fossa tumor or stroke with EVD in place for the management of hydrocephalus.

You may not qualify if:

  • Recent infection within last 1 month of presentation- can increase inflammatory markers
  • Recent surgery or acute myocardial infarction within last 1 month of presentation
  • Age \> 89 years or \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State University of New York Upstate Medical University

Syracuse, New York, 13210, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Cerebrospinal Fluid (CSF)

MeSH Terms

Conditions

Subarachnoid HemorrhageVasospasm, IntracranialHydrocephalus

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Eric M Deshaies, MD

    SUNY Upstate Medical University - Neurosurgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2012

First Posted

February 26, 2013

Study Start

April 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

November 20, 2014

Record last verified: 2014-11

Locations