The Utility of Thromboelastography in Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04524637
• Other study ID #: 18PJD034
• Status: Recruiting
• Start date: September 1, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: Shanghai 6th People's Hospital
• Contact: Hao Chen, M.D., Ph.D.
• Phone: 86-21-64369181
• Email: chenhao_316[@]aliyun.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Brain Injuries
• Brain Injuries, Traumatic
• Coagulation Disorder
• Hemostatic Disorders
• Traumatic Brain Injury
• Wounds and Injuries

Locations

Country	Name	City	State
China	Shanghai Sixth People's Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 6th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glasgow Outcome Scale scores	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.	Six months