The Relationship Between Lipid Peroxidation Products From Traumatic Brain Injury and Secondary Coagulation Disorders

• Conditions: Traumatic Brain Injury; Coagulation Disorder

• Registration Number: NCT04274777
• Lead Sponsor: Tang-Du Hospital

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.

Study Timeline

• Study Start: 2019-09-21
• Study First Submitted: 2019-09-24
• Status Verified: 2019-10
• Study First Submitted QC: 2020-02-16
• Last Update Submitted: 2020-02-16
• Study First Posted: 2020-02-18
• Last Update Posted: 2020-02-18
• Primary Completion: 2020-09-21
• Study Completion: 2020-12-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Coagulation Disorders	within 24 hours of trauma	aPTT\>40s or INR\>1.4 or \<100 platelets per L
The level of lipid peroxidation products in subjects' serum	within 24 hours of trauma	the level of high and low

Secondary Outcome Measures

Name	Time	Method
The 24-hour and 3-month Glasgow outcome score (GOS)	from onset to three months

Trial Locations

Locations (1)

Tandu Hospital, Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China