NCT03361722

Brief Summary

Vasospasm is a current complication after aneurysmal subarachnoid hemorrhage and often and often associated with brain ischemia. This complication is difficult to detect, because clinical examination is hardly helpful in sedated patients and the performances of transcranial doppler can only detect the spasm of middle cerebral arteries. Tissue Oxygen Pressure (PtiO2) Monitoring allows early detection of brain oxygenation local modifications and of brain ischemia, via continuous monitoring. This study aims to assess the performance of the tissue oxygen pressure monitoring in detecting a vasospasm post aneurysmal subarachnoid hemorrhage.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2015

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

February 15, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 5, 2017

Completed
Last Updated

December 5, 2017

Status Verified

November 1, 2017

Enrollment Period

1.6 years

First QC Date

November 29, 2017

Last Update Submit

November 29, 2017

Conditions

Subarachnoid Hemorrhage, Aneurysmal

Outcome Measures

Primary Outcomes (1)

  • Tissue Oxygen Pressure

    baseline

Eligibility Criteria

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

Adult patients, hospitalized in intensive care unit and sedated, with severe aneurysmal subarachnoid hemorrhage

You may qualify if:

  • severe aneurysmal subarachnoid hemorrhage
  • patient sedated
  • patient hospitalized in intensive care unit between January 2013 and August 2015
  • multimodal neurologic monitoring including Tissue Oxygen Pressure and transcranial doppler

You may not qualify if:

  • insonation impossible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2017

First Posted

December 5, 2017

Study Start

February 15, 2015

Primary Completion

September 15, 2016

Study Completion

September 15, 2016

Last Updated

December 5, 2017

Record last verified: 2017-11