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

February 16, 2020 updated by: Tang-Du Hospital
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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710038
        • Recruiting
        • Tandu Hospital, Fourth Military Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All of the traumatic brain injury patients receiving treatment in Tangdu Hospital during 2019-2020

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
The 24-hour and 3-month Glasgow outcome score (GOS)
Time Frame: from onset to three months
from onset to three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tang-Du Hospital

Investigators

  • Study Chair: Yan Qu, M.D, Ph.D, Tang-Du Hospital
  • Study Director: Shunnan Ge, M.D, Ph.D, Tang-Du Hospital
  • Principal Investigator: Wenxing Cui, M.D, Tang-Du Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2019

Primary Completion (Anticipated)

September 21, 2020

Study Completion (Anticipated)

December 21, 2020

Study Registration Dates

First Submitted

September 24, 2019

First Submitted That Met QC Criteria

February 16, 2020

First Posted (Actual)

February 18, 2020

Study Record Updates

Last Update Posted (Actual)

February 18, 2020

Last Update Submitted That Met QC Criteria

February 16, 2020

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TDSJWKTBIC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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