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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03786068
Other study ID # 3-3013-931/1/
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 21, 2019
Est. completion date March 30, 2019

Study information

Verified date May 2019
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Spontaneous subarachnoid haemorrhages (SAH) are a particularly severe type of stroke with a tendency to affect younger individuals than other types of stroke. The condition is time critical as early neurosurgical treatment is needed.

The aim of this study is to determine the delay from when a patient with SAH calls the Emergency Medical Services (EMS) to they are admitted to a neurosurgical department. Further, it is the aim to determine predictors for increased delay and to examine the accuracy of the triage tool used by the EMS.


Description:

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Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Denmark Rigshospitalet Copenhagen

Sponsors (3)

Lead Sponsor Collaborator
Rigshospitalet, Denmark Emergency Medical Services, Capital Region, Denmark, TrygFonden, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time from first contact to the Copenhagen Emergency Medical Communications Center to admission to a neurosurgical department in patients with spontaneous subarachnoid haemorrhage. For patients admitted between 1 May 2011 and 31 December 2014 a retrospective analysis of time to admission is performed.
Primary To identify predictors for short time to neurosurgical department. In a logistic regression model with time >/<4 hours as the dependent variable the following possible predictors are tested: Classic headache (yes/no), age (years), gender (m/f), person who is making the emergency call (patient/bystander). For patients admitted between 1 May 2011 and 31 December 2014 a retrospective analysis of emergency medical telephone calls is performed.
Secondary The proportion of patients with ´acute severe headache´, that are admitted to a neurosurgical department within four hours of initial contact to the EMCC. For patients admitted between 1 May 2011 and 31 December 2014 a retrospective analysis of time to admission is performed.
Secondary Sensitivity and positive predictive value of the Danish Index category ´acute severe headache´ for sSAH. For patients admitted between 1 May 2011 and 31 December 2014 a retrospective analysis of symptoms described in the emergency medical telephone call is performed.
Secondary Sensitivity and positive predictive value for sSAH of symptoms other than ´acute severe headache´ in the Danish Index. For patients admitted between 1 May 2011 and 31 December 2014 a retrospective analysis of symptoms described in the emergency medical telephone call is performed.
Secondary The proportion of emergency calls from sSAH-patients, that trigger a level A response, regardless of which symptom category it is triggered by. For patients admitted between 1 May 2011 and 31 December 2014 a retrospective analysis of actived responses from the Emergecny Medical Coordination Center is performed.
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