NCT00593268

Brief Summary

In this project we are collecting cerebrospinal fluid and blood from patients at Vanderbilt Medical Center who have a subarachnoid hemorrhage which has followed the rupture of a brain aneurysm. We then propose to study the cerebrospinal fluid using a novel microscopic laser directed mass spectrometric analysis (MALDI) available at Vanderbilt. The cerebrospinal fluid and blood will then be analysed for different biological markers, protein expression and gene expression. These markers will then be statistically correlated with clinical data including prediction of vasospasm, time to vasospasm and response to standard therapy.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
30mo left

Started Jun 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress90%
Jun 2004Dec 2028

Study Start

First participant enrolled

June 1, 2004

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 14, 2008

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
13.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Expected
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

11.4 years

First QC Date

January 2, 2008

Last Update Submit

March 25, 2026

Conditions

Subarachnoid Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • correlate biological markers of cerebral vasospasm with clinical outcomes

    Correlation of blood biological markers and clinical outcomes of cerebral vasospasm

    post hemorrhage

Eligibility Criteria

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

18 years of age or older

You may qualify if:

  • Patients eligible to participate in this study are those that have a documented subarachnoid hemorrhage from a ruptured cerebral aneurysm or patients who have excess cerebrospinal fluid after a Lumbar Puncture or surgery for tumor resection.
  • years of age or older

You may not qualify if:

  • Patients or family who are unable to understand the informed consent process will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center, Department of Neurological Surgery

Nashville, Tennessee, 37232, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

cerebrospinal fluid and blood

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

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

Study Officials

  • Reid C. Thomspon, M.D.

    Vanderbilt University Medical Center, Department of Neurological Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurological Surgery

Study Record Dates

First Submitted

January 2, 2008

First Posted

January 14, 2008

Study Start

June 1, 2004

Primary Completion

November 1, 2015

Study Completion (Estimated)

December 1, 2028

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations

US(1)