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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04524637
Other study ID # 18PJD034
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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