NCT04415736

Brief Summary

The overall aim of this study is to, with the help of computer/data scientist and machine learning processes, analyse collected heart rate variability data in order to evaluate whether specific patterns could be found in patients developing delayed cerebral ischemia after subarachnoid hemorrhage.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2015

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
Last Updated

September 3, 2020

Status Verified

September 1, 2020

Enrollment Period

1 year

First QC Date

May 26, 2020

Last Update Submit

September 1, 2020

Conditions

Subarachnoid Hemorrhage, Aneurysmal

Outcome Measures

Primary Outcomes (1)

  • HRV data analysed by artificial intelligence for detection of DCI

    Variability of the time of R-R intervals of each heartbeat is measured.

    2020

Study Arms (2)

Delayed cerebral ischemia

Patients with subarachnoid hemorrhage that develop delayed cerebral ischemia

Other: No intervention, observational study

Non delayed cerebral ischemia

Patients with subarachnoid hemorrhage that do not develop subarachnoid hemorrhage

Other: No intervention, observational study

Interventions

No intervention, observational studyOTHER
Delayed cerebral ischemiaNon delayed cerebral ischemia

Eligibility Criteria

Age16 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients with aneurysmal subarachnoid hemorrhage, admitted to the Intensive Care Unit at Sahlgrenska University Hospital.

You may qualify if:

  • Adult patients
  • aneurysmal subarachnoid hemorrhage
  • admitted to Neurointensive care unit at Sahlgrenska University Hospital, Gothenburg, Sweden

You may not qualify if:

  • cardiac arrythmias
  • use of pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

Observation

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Miroslaw Staron, Prof

    Göteborg University

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

May 26, 2020

First Posted

June 4, 2020

Study Start

October 1, 2015

Primary Completion

October 1, 2016

Study Completion

May 1, 2020

Last Updated

September 3, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)