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Clinical Trials/NCT04524637
NCT04524637
Recruiting
Not Applicable

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

Shanghai 6th People's Hospital1 site in 1 country500 target enrollmentSeptember 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Traumatic Brain Injury
Sponsor
Shanghai 6th People's Hospital
Enrollment
500
Locations
1
Primary Endpoint
Glasgow Outcome Scale scores
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2018
End Date
December 31, 2027
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hao Chen, MD, PhD

Associate Clinical Professor

Shanghai 6th People's Hospital

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

Outcomes

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 Sites (1)

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