NCT05094349

Brief Summary

Prognosis of subarachnoid hemorrhage (SAH) is scarce, indeed almost half patients die or become severely disable after SAH. Outcome is related to the severity of the initial bleeding and delayed cerebral infarction (DCI). Infection and more precisely pneumonia have been associated with poor outcome in SAH. However, the interaction between the two pathologic events remains unclear. Therefore, we hypothesized that DCI may be associated to pneumonia in SAH patients. Thus the aim of the study is to analyze the association between delayed cerebral infarction and pneumonia in patients with SAH. Retrospective, observational, monocentric cohort study, including patient admitted in Neurosurgical Intensive Care Unit or Surgical Intensive Care Unit in the University Hospital of Brest (France) for non-traumatic SAH. Primary outcome is diagnosis of DCI on CT scan or MRI 3 months after SAH. Multivariate analysis is used to identify factors independently associated with DCI. We plan to include between 200 and 250 patients in the analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
224

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
Last Updated

October 26, 2021

Status Verified

October 1, 2021

Enrollment Period

5 months

First QC Date

October 14, 2021

Last Update Submit

October 14, 2021

Conditions

Keywords

Subarachnoid hemorrhagepneumoniadelayed cerebral ischemiavasospasmdelayed cerebral infarction

Outcome Measures

Primary Outcomes (1)

  • delayed cerebral infarction

    infarction on CT or MRI not related to initial bleeding

    3 months from subarachnoid hemorrhage

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patient admitted to ICU for subarachnoid hemorrhage (SAH). in our institution every patient diagnosed with non traumatic SAH are admitted for at least 24 hours in ICU.

You may qualify if:

  • admitted in ICU in Brest University Hospital
  • for non traumatic subarachnoid hemorrhage
  • between july 2015 and december 2018

You may not qualify if:

  • continuation of care out of Brest University Hospital after initial ICU stay
  • refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Subarachnoid HemorrhagePneumonia, BacterialPneumonia

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

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

Study Record Dates

First Submitted

October 14, 2021

First Posted

October 26, 2021

Study Start

February 20, 2020

Primary Completion

July 15, 2020

Study Completion

July 15, 2020

Last Updated

October 26, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available beginning 2 years and ending five years following the end of study
Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations