The Utility of Thromboelastography in Traumatic Brain Injury

NCT ID: NCT04524637

Last Updated: 2025-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-01

Study Completion Date

2027-12-31

Brief Summary

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Hemocoagulation disorder is recognized to have crucial effects on hemorrhagic or ischemic diseases. Coagulation-related damages secondary to traumatic brain injury are common and severe secondary insults of head trauma and often leads to a poor prognosis. In this study, we sought to assess if posttraumatic hemocoagulation disorders determined using thromboelastography are associated with coagulation-related damages secondary to traumatic brain injury, and evaluate their influence on outcome among patients with head trauma. Based on above results, prediction models or risk scoring systems will be further developed and validated to predict coagulation-related damages secondary to traumatic brain injury.

Detailed Description

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Conditions

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Traumatic Brain Injury Coagulation Disorder

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Traumatic brain injury

Patients who are delivered within 24 hours after head trauma and sustain isolated traumatic brain injury are included in this study.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients who are delivered to hospital within 24 hours after head trauma
* Patients whose abbreviated injury score (AIS) for other body regions is 3 or less are considered to be isolated traumatic brain injury

Exclusion Criteria

* Patients with existing prior neurological disease
* Patients with known coagulation disorders
* Patients on anticoagulants and medications known to affect coagulation function within 30 days before trauma
* Patients receiving blood components prior to blood draw
* Patients who deteriorate and die before determining whether coagulation- related damage exists
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai 6th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hao Chen, MD, PhD

Associate Professor, Chief Physician, Graduate Supervisor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hao Chen, M.D., Ph.D.

Role: STUDY_DIRECTOR

Shanghai 6th People's Hospital

Locations

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Shanghai Sixth People's Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hao Chen, M.D., Ph.D.

Role: CONTACT

86-21-64369181 ext. 8405

Facility Contacts

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Hao Chen, M.D., Ph.D.

Role: primary

Other Identifiers

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18PJD034

Identifier Type: -

Identifier Source: org_study_id

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