Clinical trial NCT04274777: The Relationship Between Lipid Peroxidation Products From Traumatic Brain Injury and Secondary Coagulation Disorders
Official title: The Relationship Between Lipid Peroxidation Products From Traumatic Brain Injury and Secondary Coagulation Disorders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Traumatic Brain Injury
Coagulation Disorder
Keywords: Traumatic Brain Injury
Coagulation Disorder
Lipid Peroxidation
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2020-02-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All of the traumatic brain injury patients receiving treatment in Tangdu Hospital during 2019-2020

Brief summary: The purpose of this study is to observe the relationship between the level of lipid peroxidation products in serum of patients with traumatic brain injury and secondary coagulation disorders.

Detailed description: Uncontrolled hemorrhage after trauma is the leading cause of death. The mechanism of secondary coagulation dysfunction after trauma is special and complex, which has not been fully explained, leading to limited treatment and prevention methods. Coagulation disorders caused by traumatic brain injury is a systemic manifestation of local injury, which can activate platelets and promote platelet aggregation, activate thrombin, and promote the production of fibrin, leading to the formation of thrombosis. However, in non-injured areas, pro-coagulant molecules from damaged brain tissue reach the body through the broken blood-brain barrier, and also activate platelets and thrombin, promoting the formation of blood clots. Lipid peroxidation products are closely related to the occurrence of coagulation dysfunction. The effects lipid peroxidation products on platelets, thrombin and anticoagulant pathways may be a novel mechanism of secondary coagulation dysfunction in traumatic brain injury.

Eligibility criteria: Inclusion Criteria:

1. The interval between injury and admission is less than 24 hours
2. Age\>18yrs and age\<80yrs
3. Non-head abbreviated injury score \< 3
4. Did not undertake treatment before enrollment
5. Informed consent to participate in the study

Exclusion Criteria:

1. Take anticoagulants or antiplatelet drugs
2. Smoking history
3. Hemorrhagic or ischemic cerebrovascular disease occurred within six months
4. Other systemic diseases: uremia, cirrhosis, malignant tumor, etc
5. Patients with severe mental illness who are unable to communicate when diagnosed
6. Patients who refused follow-up

Primary outcomes:
measure: The level of lipid peroxidation products in subjects' serum
timeFrame: within 24 hours of trauma
measure: Coagulation Disorders
timeFrame: within 24 hours of trauma
Secondary outcomes:
measure: The 24-hour and 3-month Glasgow outcome score (GOS)
timeFrame: from onset to three months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Tandu Hospital, Fourth Military Medical University
state: Shaanxi
Study officials:
affiliation: Tang-Du Hospital
name: Yan Qu, M.D, Ph.D
role: STUDY_CHAIR
affiliation: Tang-Du Hospital
name: Shunnan Ge, M.D, Ph.D
role: STUDY_DIRECTOR
affiliation: Tang-Du Hospital
name: Wenxing Cui, M.D
role: PRINCIPAL_INVESTIGATOR
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