NCT02222597

Brief Summary

The purpose of this study is to evaluate Near-Infrared Spectroscopy for intracranial hematoma detection of head trauma patients

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Last Updated

August 26, 2014

Status Verified

August 1, 2014

Enrollment Period

8 months

First QC Date

August 20, 2014

Last Update Submit

August 24, 2014

Conditions

Within 12 Hrs of Head Injury

Keywords

head injuryinfrascannerintracranial hemorrhage

Outcome Measures

Primary Outcomes (1)

  • detect the predictive value of the infrascanner for intracranial hemorrhage

    within 12 hours after head injury

Study Arms (1)

positive infrascanner finding

Device: infrascanner

Interventions

infrascannerDEVICE
positive infrascanner finding

Eligibility Criteria

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

The patients within 12 hours after head injury visit the Emergency Department of the NTUH.

You may qualify if:

  • The patients within 12 hours after head injury, visiting the Emergency Department of the National Taiwan University Hospital, and receiving computed tomography of head were enrolled.

You may not qualify if:

  • The patients over 12 hours after head injury, visiting the Emergency Department of the NTUH, and receiving computed tomography of head were excluded.
  • Patients with massive scalp laceration or hematoma were excluded. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital Emergency Department

Taipei, Taiwan, Taiwan

RECRUITING

MeSH Terms

Conditions

Craniocerebral TraumaIntracranial Hemorrhages

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and InjuriesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Meng-Che Wu, MD

CONTACT

+886-972653208mengcher111@gmail.com

Cheng-Yi Wu, MD

CONTACT

+886-972653218alanwuem@gmail.com

Study Design

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

Study Record Dates

First Submitted

August 20, 2014

First Posted

August 21, 2014

Study Start

April 1, 2014

Primary Completion

December 1, 2014

Last Updated

August 26, 2014

Record last verified: 2014-08

Locations

TW(1)