The Utility of Thromboelastography in Traumatic Brain Injury

NCT04524637 | Recruiting

• 1 other identifier: 18PJD034
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury; Coagulation Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Traumatic brain injury

Patients who are delivered within 24 hours after head trauma and sustain isolated traumatic brain injury are included in this study.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients (18-80 years old) with isolated traumatic brain injury, who are admitted within 24 hours post-injury are included. To avoid interfering factors, patients with existing prior neurological disease or known coagulation disorders, patients on anticoagulants and medications known to affect coagulation function within 30 days before trauma or receiving blood components prior to blood draw, patients who deteriorate and die before determining whether coagulation-related damage exists are excluded. Clinical data are documented, including age, gender, mechanisms of trauma, types of lesions as evidenced by imaging examination and laboratory examination, etc.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai 6th People's Hospital: lead

Study Sites (1)

Shanghai Sixth People's Hospital

Shanghai, 200233, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples are taken from the antecubital vein for thromboelastography analysis within the first 24 h after head trauma for all patients.

MeSH Terms

Conditions

Brain Injuries, Traumatic; Hemostatic Disorders

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Hao Chen, M.D., Ph.D.

  Shanghai 6th People's Hospital

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

86-21-64369181; chenhao_316@aliyun.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Chief Physician, Graduate Supervisor

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: August 24, 2020
• Study Start: September 1, 2018
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 17, 2025

Record last verified: 2025-03

Locations

CN (1)