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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05094349
Other study ID # SAH-CIP (29BRC19.0311)
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 20, 2020
Est. completion date July 15, 2020

Study information

Verified date October 2021
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 224
Est. completion date July 15, 2020
Est. primary completion date July 15, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - admitted in ICU in Brest University Hospital - for non traumatic subarachnoid hemorrhage - between july 2015 and december 2018 Exclusion Criteria: - continuation of care out of Brest University Hospital after initial ICU stay - refusal to participate

Study Design


Locations

Country Name City State
France CHRU de Brest Brest

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary delayed cerebral infarction infarction on CT or MRI not related to initial bleeding 3 months from subarachnoid hemorrhage
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