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Traumatic Brain InjuryNCT04274777

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

An observational study of Traumatic Brain Injury and Coagulation Disorder, run by Tang-Du Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Traumatic Brain Injury, Coagulation Disorder
How many people
100 participants
Where
1 siteChina
Study dates
21 Sep 2019to 21 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Wenxing Cui, M.D contact

86-17367277315

wenxingcui@qq.com

China1 site, 1 recruiting

  • Tandu Hospital, Fourth Military Medical University

    Xi'an, Shaanxi, 710038

    Wenxing Cui, M.D, 86-17367277315, wenxingcui@qq.com

    Recruiting

Other trials in China

About this study

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.

Read the 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.

Keywords
Traumatic Brain Injury, Coagulation Disorder, Lipid Peroxidation
Medical subject headings
Brain Injuries, Traumatic, Hemostatic Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The level of lipid peroxidation products in subjects' serum

    the level of high and low

    Measured: within 24 hours of trauma

  2. Coagulation Disorders

    aPTT>40s or INR>1.4 or <100 platelets per L

    Measured: within 24 hours of trauma

Secondary outcomes (1)

  1. The 24-hour and 3-month Glasgow outcome score (GOS)

    Measured: from onset to three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2020
  2. Study start21 Sep 2019
  3. Primary completion21 Sep 2020 (estimated)
  4. Study completion21 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04274777
Sponsor's protocol ID
TDSJWKTBIC
Status last verified
Oct 2019
First submitted
24 Sep 2019
Last updated
18 Feb 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 18166989

  • 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.

    PubMed 24529718

  • 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. doi: 10.1016/j.resuscitation.2007.06.024. Epub 2007 Aug 15.

    PubMed 17706857

  • 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. doi: 10.1007/978-3-7091-6837-0_32.

    PubMed 9416292

  • 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.

    PubMed 29507078

  • 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.

    PubMed 27002118

  • 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.

    PubMed 29941674

  • 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.

    PubMed 25628471

  • 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.

    PubMed 29162596

  • Rossaint R, Bouillon B, Cerny V, Coats TJ, Duranteau J, Fernandez-Mondejar 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.

    PubMed 27072503

  • 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.

    PubMed 18162698

  • 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.

    PubMed 21355766

Questions about this trial

What is this clinical trial studying?

An observational study of Traumatic Brain Injury and Coagulation Disorder, run by Tang-Du Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Wenxing Cui, M.D (86-17367277315, wenxingcui@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The level of lipid peroxidation products in subjects' serum (time frame: within 24 hours of trauma). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04274777, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2020.

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