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Clinical Evaluation of the i-STAT TBI Test

NCT04171960 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1106

Last updated 2024-09-19

No results posted yet for this study

Summary

The goal of this study is to evaluate the i-STAT TBI test to assist determining the need for a computed tomography (CT) scan in patients with suspected mild traumatic brain injury (TBI).

Patients will be asked to provide a blood sample.

Conditions

Interventions

DIAGNOSTIC_TEST

Blood draw

Venous whole blood collection within 12 hours and 12-24 hours following injury.

OTHER

Outcome assessments

Administered at baseline.

Sponsors & Collaborators

Principal Investigators

  • Manish Gupta, MS, MBA · Abbott Point of Care

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-31
Primary Completion
2023-06-26
Completion
2023-11-29
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04171960 on ClinicalTrials.gov