The Utility of Thromboelastography in Traumatic Brain Injury

The Utility of Thromboelastography for Predicting the Risk of Coagulation-Related Damages Secondary to Traumatic Brain Injury

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04524637

Enrollment

500

Registered

2020-08-24

Start date

2018-09-01

Completion date

2027-12-31

Last updated

2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coagulation Disorder, Traumatic Brain Injury

Keywords

Thrombelastography, Coagulation Disorder, Traumatic Brain Injury, Coagulation-related damages

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Glasgow Outcome Scale scores	Six months	Glasgow Outcome Scale 1 = death; Glasgow Outcome Scale 2 = vegetative state; Glasgow Outcome Scale 3 = severe neurological deficit; Glasgow Outcome Scale 4 = mild neurological deficit and Glasgow Outcome Scale 5 = premorbid level of functioning or completely recovery. Unfavorable outcome is defined as a Glasgow Outcome Scale score of ≤ 3, and favorable outcome is defined as a Glasgow Outcome Scale score of \> 3.

Countries

China

Contacts

Primary ContactHao Chen, M.D., Ph.D.

chenhao_316@aliyun.com86-21-64369181

Outcome results