Long-term Effects of Time to Treatment in Subarachnoid Haemorrhage

• Sponsor: Rigshospitalet, Denmark (Other)
• Overall Status: Completed
• CT.gov ID: NCT04377347
• Collaborator: (none)
• Enrollment: 537
• Location: 1
• Actual Duration (Months): 9.8
• Patients Per Site Per Month: 54.7

Study Details

Study Description

Brief Summary

For patients with spontaneous subarachnoid haemorrhage, it remains to be investigated if there is an association between the time from patients call the Emergence Medical Coordination Center to neurosurgical admission and long-term outcome.

This is a retrospective cohort study with four-year followup. The primary aim is to determine if the time to neurosurgical admission is associated to labour marked affiliation and mortality after four years.

Condition or Disease	Intervention/Treatment	Phase
Spontaneous Subarachnoid Hemorrhage	Other: Time

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 537 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: Time From First Health Care Contact to Neurosurgical Admission and the Effect on Long-term Labour Market Affiliation and Mortality in Patients With Spontaneous Subarachnoid Haemorrhage
• Actual Study Start Date: May 1, 2020
• Actual Primary Completion Date: Feb 24, 2021
• Actual Study Completion Date: Feb 24, 2021

Arms and Interventions

Arm

Intervention/Treatment

Confirmed spontaneous subarachnoid haemorrhage Patients, minimum 18 years of age, identified with the diagnosis in the Danish National Patient Register. The diagnosis is verified by medical record review. All patients were initially admitted to a hospital in the Capital Region of Denmark. In a national labour marked register and the civil registration register the patients are then followed for four years.

Other: Time; Exposure is the time from patients call the Emergency Medical Coordination Center to they are admitted to a neurosurgiocal department.

Outcome Measures

Primary Outcome Measures

1. Labour marked affiliation and mortality [4 years]

   The incidence of all-cause death and early retirement over the four-years after sSAH for different times to treatment is shown with Kaplan-Meier plots, and assessed with log-rank tests.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Spontaneous subarachnoid haemorrhage registered in the Danish National Patient Register and confirmed by medical record review.

• Initially admitted to a hospital in the Capital Region of Denmark between 1 January 2008 and 31 December 2014.

Exclusion Criteria:

• Prior subarachnoid haemorrhage.

• Inhospital symptom onset.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rigshospitalet	Copenhagen		Denmark

Sponsors and Collaborators

• Rigshospitalet, Denmark

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Asger Sonne, MD, Principal investigator, Rigshospitalet, Denmark
• ClinicalTrials.gov Identifier: NCT04377347
• Other Study ID Numbers: Outcome
• First Posted: May 6, 2020
• Last Update Posted: Feb 25, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Subarachnoid Hemorrhage; Hemorrhage

Study Results

No Results Posted as of Feb 25, 2021