NCT02389634

Brief Summary

The purpose of the study is to identify novel genetic and protein markers for the process of cerebral vasospasm following aneurysmal subarachnoid hemorrhage.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2010

Longer than P75 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

September 1, 2010

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2019

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

9.2 years

First QC Date

March 10, 2015

Last Update Submit

April 17, 2024

Conditions

Cerebral VasospasmSubarachnoid Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Identification of vasospasm via microRNA mediators prior to clinically evident signs and symptoms

    Identification of vasospasm via microRNA mediators prior to clinically evident signs and symptoms

    30 days

Eligibility Criteria

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

Adult patients with aneurysmal subarachnoid hemorrhage

You may qualify if:

  • Adult patients with aneurysmal subarachnoid hemorrhage within 24-hours of bleed.
  • Receive either open vascular clipping or endovascular coiling.

You may not qualify if:

  • Patients under 18 years of age.
  • Patients arriving at the hospital \>24-hours post-hemorrhage.
  • Patients who are not candidates for further care.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barrow Neurological Institute at St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood and cerebrospinal fluid

MeSH Terms

Conditions

Vasospasm, IntracranialSubarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

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

Study Officials

  • Robert F Spetzler, MD

    Saint Joseph's Hospital and Medical Center/Barrow Neurological Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Operations Manager

Study Record Dates

First Submitted

March 10, 2015

First Posted

March 17, 2015

Study Start

September 1, 2010

Primary Completion

October 25, 2019

Study Completion

October 25, 2019

Last Updated

April 19, 2024

Record last verified: 2024-04

Locations

US(1)