The Utility of Thromboelastography in Traumatic Brain Injury

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Cardiovascular Diseases Central Nervous System Diseases Coagulation Disorder Craniocerebral Trauma Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Nervous System Diseases Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Sixth People's Hospital

Shanghai, 200233, China

Location status: Recruiting

Location contact

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

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Glasgow Outcome Scale scores

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

86-21-64369181 ext. 8405

Sponsors and collaborators

Lead sponsor

Shanghai 6th People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2027
Study completion: 2027
First posted: Aug 24, 2020
Registry last updated: Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed