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Recruiting NCT04524637

The Utility of Thromboelastography in Traumatic Brain Injury

Observational Traumatic Brain Injury Coagulation Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Traumatic Brain Injury, Coagulation Disorder. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Glasgow Outcome Scale scores [Time frame: Six months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

China · 1 center
  • Shanghai Sixth People's Hospital — Shanghai

Identifiers

NCT: NCT04524637 · 18PJD034

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗