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The Utility of Thromboelastography in Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04524637
Recruitment Status : Recruiting
First Posted : August 24, 2020
Last Update Posted : August 25, 2020
Sponsor:
Information provided by (Responsible Party):
Hao Chen, Shanghai 6th People's Hospital

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.

Condition or disease
Traumatic Brain Injury Coagulation Disorder

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Utility of Thromboelastography for Predicting the Risk of Coagulation-Related Damages Secondary to Traumatic Brain Injury
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.


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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04524637


Contacts
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Contact: Hao Chen, M.D., Ph.D. 86-21-64369181 ext 8405 chenhao_316@aliyun.com

Locations
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China
Shanghai Sixth People's Hospital Recruiting
Shanghai, China, 200233
Contact: Hao Chen, M.D., Ph.D.         
Sponsors and Collaborators
Shanghai 6th People's Hospital
Investigators
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Study Director: Hao Chen, M.D., Ph.D. Shanghai 6th People's Hospital
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Responsible Party: Hao Chen, Associate Clinical Professor, Shanghai 6th People's Hospital
ClinicalTrials.gov Identifier: NCT04524637    
Other Study ID Numbers: 18PJD034
First Posted: August 24, 2020    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hao Chen, Shanghai 6th People's Hospital:
Thrombelastography
Coagulation Disorder
Traumatic Brain Injury
Coagulation-related damages
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Craniocerebral Trauma
Trauma, Nervous System
Hemostatic Disorders
Blood Coagulation Disorders
Central Nervous System Diseases
Nervous System Diseases
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders