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Time to Specialized Admission in Case of Severe Brain Haemorrhage.

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ClinicalTrials.gov Identifier: NCT03786068
Recruitment Status : Completed
First Posted : December 24, 2018
Last Update Posted : May 13, 2019
Sponsor:
Collaborators:
TrygFonden, Denmark
Emergency Medical Services, Capital Region, Denmark
Information provided by (Responsible Party):
Asger Sonne, MD, Rigshospitalet, Denmark

Brief 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.


Condition or disease
Spontaneous Subarachnoid Hemorrhage

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Actual Enrollment : 262 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 1 Day
Official Title: Telephone Triage and Spontaneous Subarachnoid Haemorrhage; Predictors of Timely Admission to Neurosurgical Care
Actual Study Start Date : January 21, 2019
Actual Primary Completion Date : March 30, 2019
Actual Study Completion Date : March 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding




Primary Outcome Measures :
  1. Time from first contact to the Copenhagen Emergency Medical Communications Center to admission to a neurosurgical department in patients with spontaneous subarachnoid haemorrhage. [ Time Frame: For patients admitted between 1 May 2011 and 31 December 2014 a retrospective analysis of time to admission is performed. ]
  2. To identify predictors for short time to neurosurgical department. [ Time Frame: For patients admitted between 1 May 2011 and 31 December 2014 a retrospective analysis of emergency medical telephone calls is performed. ]
    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).


Secondary Outcome Measures :
  1. The proportion of patients with ´acute severe headache´, that are admitted to a neurosurgical department within four hours of initial contact to the EMCC. [ Time Frame: For patients admitted between 1 May 2011 and 31 December 2014 a retrospective analysis of time to admission is performed. ]
  2. Sensitivity and positive predictive value of the Danish Index category ´acute severe headache´ for sSAH. [ Time Frame: 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. ]
  3. Sensitivity and positive predictive value for sSAH of symptoms other than ´acute severe headache´ in the Danish Index. [ Time Frame: 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. ]
  4. The proportion of emergency calls from sSAH-patients, that trigger a level A response, regardless of which symptom category it is triggered by. [ Time Frame: 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients registered with spontaneous subarachnoid haemorrhage (International Classification of Disease version 10 diagnoses DI60-DI60.9) in the Danish National Patient Register, admitted to a hospital in the Capital Region of Denmark between 1 May 2011 - 31 December 2014, aged ≥18 years on admission are registered in this database. Patients diagnoses were validated by medical record review.
Criteria

Inclusion Criteria:

  • Patients with first-time spontaneous subarachnoid haemorrhage in the Capital Region of Denmark between 1 May 2011 and 31 December 2014 and contact to the Copenhagen EMCC.

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786068


Locations
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Denmark
Rigshospitalet
Copenhagen, Denmark
Sponsors and Collaborators
Rigshospitalet, Denmark
TrygFonden, Denmark
Emergency Medical Services, Capital Region, Denmark

Additional Information:

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Responsible Party: Asger Sonne, MD, Clinical assistant, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03786068     History of Changes
Other Study ID Numbers: 3-3013-931/1/
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Asger Sonne, MD, Rigshospitalet, Denmark:
Emergency Medical Services
Prehospital
Time to admission
Time to neurosurgery
Treatment delay

Additional relevant MeSH terms:
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Hemorrhage
Subarachnoid Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases