NCT03191279

Brief Summary

The study aims to assess the effect of first aid from bystanders on survival, admission length, and need of ICU-stay for trauma victims.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 19, 2017

Completed
1.1 years until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

June 19, 2017

Status Verified

June 1, 2017

Enrollment Period

2 years

First QC Date

May 3, 2017

Last Update Submit

June 15, 2017

Conditions

Keywords

Wounds and injuryTraumaFirst aidBystanderLaypersons

Outcome Measures

Primary Outcomes (3)

  • Admission length

    Length of hospital stay after injury, in days

    3 months after inclusion

  • Survival

    30-day survival, starting from day of injury

    1 month after inclusion

  • Need of ICU stay

    Whether patient is admitted to ICU during admission

    3 months after inclusion

Secondary Outcomes (1)

  • Length of ICU stay

    3 months after inclusion

Other Outcomes (2)

  • Whether patients received first aid from bystanders

    At time of inclusion

  • Whether first aid measures were indicated for the patient

    At time of inclusion

Study Arms (3)

First aid correct

Patient has received first aid according to local guidelines for all indicated first aid measures from bystanders on scene of accident when the first ambulance arrives

Procedure: First aid

First aid attempted

Bystanders have attempted first aid for indicated first aid measures, but measures have been incorrectly performed according to local guidelines

Procedure: First aid

No first aid

Indicated first aid measures have not been carried out when the first ambulance arrives on scene

Interventions

First aidPROCEDURE

Open airway (head tilt, chin lift), recovery position, staunch of bleeding, prevention of hypothermia, cooling of burn, CPR

First aid attemptedFirst aid correct

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who has sustained an injury and where the EMS has been alerted and initiated an emergency response

You may qualify if:

  • All emergency response calls to trauma (drownings and hangings included)

You may not qualify if:

  • No injury to patient
  • Non-traumatic condition
  • Poisonings

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNN Tromsø

Tromsø, 9037, Norway

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

First Aid

Intervention Hierarchy (Ancestors)

Emergency TreatmentTherapeutics

Central Study Contacts

Håkon Kvåle Bakke, MD, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

May 3, 2017

First Posted

June 19, 2017

Study Start

August 1, 2018

Primary Completion

August 1, 2020

Study Completion

August 1, 2021

Last Updated

June 19, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

No plan of sharing IDP

Locations