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NCT04274777 Clinical Trial

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

Traumatic Brain Injury Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04274777
Other study ID # TDSJWKTBIC
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 21, 2019
Est. completion date December 21, 2020

Study information
Verified date October 2019
Source Tang-Du Hospital
Contact Wenxing Cui, M.D
Phone 86-17367277315
Email wenxingcui@qq.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 21, 2020
Est. primary completion date September 21, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
China Tandu Hospital, Fourth Military Medical University Xi'an Shaanxi

Sponsors (1)
Lead Sponsor Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

References & Publications (12)

Epstein DS, Mitra B, O'Reilly G, Rosenfeld JV, Cameron PA. Acute traumatic coagulopathy in the setting of isolated traumatic brain injury: a systematic review and meta-analysis. Injury. 2014 May;45(5):819-24. doi: 10.1016/j.injury.2014.01.011. Epub 2014 Jan 19. Review. — View Citation

Harhangi BS, Kompanje EJ, Leebeek FW, Maas AI. Coagulation disorders after traumatic brain injury. Acta Neurochir (Wien). 2008 Feb;150(2):165-75; discussion 175. doi: 10.1007/s00701-007-1475-8. Epub 2008 Jan 2. Review. — View Citation

Hyder AA, Wunderlich CA, Puvanachandra P, Gururaj G, Kobusingye OC. The impact of traumatic brain injuries: a global perspective. NeuroRehabilitation. 2007;22(5):341-53. Review. — View Citation

Maeda T, Katayama Y, Kawamata T, Aoyama N, Mori T. Hemodynamic depression and microthrombosis in the peripheral areas of cortical contusion in the rat: role of platelet activating factor. Acta Neurochir Suppl. 1997;70:102-5. — View Citation

Rossaint R, Bouillon B, Cerny V, Coats TJ, Duranteau J, Fernández-Mondéjar E, Filipescu D, Hunt BJ, Komadina R, Nardi G, Neugebauer EA, Ozier Y, Riddez L, Schultz A, Vincent JL, Spahn DR. The European guideline on management of major bleeding and coagulopathy following trauma: fourth edition. Crit Care. 2016 Apr 12;20:100. doi: 10.1186/s13054-016-1265-x. — View Citation

Sun Y, Wang J, Wu X, Xi C, Gai Y, Liu H, Yuan Q, Wang E, Gao L, Hu J, Zhou L. Validating the incidence of coagulopathy and disseminated intravascular coagulation in patients with traumatic brain injury--analysis of 242 cases. Br J Neurosurg. 2011 Jun;25(3):363-8. doi: 10.3109/02688697.2011.552650. Epub 2011 Feb 28. — View Citation

Tian Y, Salsbery B, Wang M, Yuan H, Yang J, Zhao Z, Wu X, Zhang Y, Konkle BA, Thiagarajan P, Li M, Zhang J, Dong JF. Brain-derived microparticles induce systemic coagulation in a murine model of traumatic brain injury. Blood. 2015 Mar 26;125(13):2151-9. doi: 10.1182/blood-2014-09-598805. Epub 2015 Jan 27. — View Citation

Wu Y, Liu W, Zhou Y, Hilton T, Zhao Z, Liu W, Wang M, Yeon J, Houck K, Thiagarajan P, Zhang F, Shi FD, Wu X, Li M, Dong JF, Zhang J. von Willebrand factor enhances microvesicle-induced vascular leakage and coagulopathy in mice with traumatic brain injury. Blood. 2018 Sep 6;132(10):1075-1084. doi: 10.1182/blood-2018-03-841932. Epub 2018 Jun 25. — View Citation

Zehtabchi S, Soghoian S, Liu Y, Carmody K, Shah L, Whittaker B, Sinert R. The association of coagulopathy and traumatic brain injury in patients with isolated head injury. Resuscitation. 2008 Jan;76(1):52-6. Epub 2007 Aug 15. — View Citation

Zhang J, Zhang F, Dong JF. Coagulopathy induced by traumatic brain injury: systemic manifestation of a localized injury. Blood. 2018 May 3;131(18):2001-2006. doi: 10.1182/blood-2017-11-784108. Epub 2018 Mar 5. Review. — View Citation

Zhao Z, Wang M, Tian Y, Hilton T, Salsbery B, Zhou EZ, Wu X, Thiagarajan P, Boilard E, Li M, Zhang J, Dong JF. Cardiolipin-mediated procoagulant activity of mitochondria contributes to traumatic brain injury-associated coagulopathy in mice. Blood. 2016 Jun 2;127(22):2763-72. doi: 10.1182/blood-2015-12-688838. Epub 2016 Mar 21. — View Citation

Zhou Y, Cai W, Zhao Z, Hilton T, Wang M, Yeon J, Liu W, Zhang F, Shi FD, Wu X, Thiagarajan P, Li M, Zhang J, Dong JF. Lactadherin promotes microvesicle clearance to prevent coagulopathy and improves survival of severe TBI mice. Blood. 2018 Feb 1;131(5):563-572. doi: 10.1182/blood-2017-08-801738. Epub 2017 Nov 21. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome
Type Measure Description Time frame Safety issue
Primary The level of lipid peroxidation products in subjects' serum the level of high and low within 24 hours of trauma
Primary Coagulation Disorders aPTT>40s or INR>1.4 or <100 platelets per L within 24 hours of trauma
Secondary The 24-hour and 3-month Glasgow outcome score (GOS) from onset to three months
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