NCT01406457

Brief Summary

The goal in this research is to develop better ways to detect and treat the damage caused by bleeding in the brain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2010

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

June 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

October 21, 2015

Status Verified

October 1, 2015

Enrollment Period

2.5 years

First QC Date

July 28, 2011

Last Update Submit

October 20, 2015

Conditions

Subarachnoid Hemorrhage

Keywords

Subarachnoid Hemorrhage

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with subarachnoid hemmorhage clinical symptoms

You may qualify if:

  • Age 18 to 70 years
  • World Federation of Neurosurgery (WFNS) grade III-IV, and grade V patients who improve within 24h after ventriculostomy
  • Diffuse thick or localized thick subarachnoid clot \>1 mm on baseline CT (Fisher grade 3-4)
  • Ruptured saccular aneurysm demonstrated by CT-angiography or DSA
  • Onset of aSAH clinical symptoms within the preceding 72h
  • Treatment of aneurysm within 24 h after admission
  • Treatment of aneurysm by clip ligation

You may not qualify if:

  • SAH due to other causes (e.g. trauma, fusiform or mycotic aneurysm)
  • Only a thin diffuse layer or no visible subarachnoid blood in the initial CT
  • Admission in a clinical state with unfavourable prognosis (e.g., bilateral dilated, non-reactive pupils for more than 1h)
  • Coagulopathy (thrombocytes \<60,000/ml or INR\>1.5)
  • Pregnancy
  • Presence of incompatibilities for MRI, such as non-removable metals, artificial joints, electronic devices (pace maker, pumps), etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

Biospecimen

No specimens are to be retained.

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

  • Jed Hartings, PhD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Asst Professor

Study Record Dates

First Submitted

July 28, 2011

First Posted

August 1, 2011

Study Start

June 1, 2010

Primary Completion

December 1, 2012

Study Completion

March 1, 2014

Last Updated

October 21, 2015

Record last verified: 2015-10

Locations

US(1)