NCT04274777

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2019

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 18, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2020

Completed
Last Updated

February 18, 2020

Status Verified

October 1, 2019

Enrollment Period

1 year

First QC Date

September 24, 2019

Last Update Submit

February 16, 2020

Conditions

Traumatic Brain InjuryCoagulation Disorder

Keywords

Traumatic Brain InjuryCoagulation DisorderLipid Peroxidation

Outcome Measures

Primary Outcomes (2)

  • The level of lipid peroxidation products in subjects' serum

    the level of high and low

    within 24 hours of trauma

  • Coagulation Disorders

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

    within 24 hours of trauma

Secondary Outcomes (1)

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

    from onset to three months

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tandu Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710038, China

RECRUITING

Related Publications (12)

  • 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.

    PMID: 18166989BACKGROUND

  • 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.

    PMID: 24529718BACKGROUND

  • 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.

    PMID: 17706857BACKGROUND

  • 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.

    PMID: 9416292BACKGROUND

  • 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.

    PMID: 29507078BACKGROUND

  • 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.

    PMID: 27002118BACKGROUND

  • 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.

    PMID: 29941674BACKGROUND

  • 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.

    PMID: 25628471BACKGROUND

  • 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.

    PMID: 29162596BACKGROUND

  • 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.

    PMID: 27072503BACKGROUND

  • 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.

    PMID: 18162698BACKGROUND

  • 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.

    PMID: 21355766BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Brain Injuries, TraumaticHemostatic Disorders

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Yan Qu, M.D, Ph.D

    Tang-Du Hospital

    STUDY CHAIR

  • Shunnan Ge, M.D, Ph.D

    Tang-Du Hospital

    STUDY DIRECTOR

  • Wenxing Cui, M.D

    Tang-Du Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenxing Cui, M.D

CONTACT

86-17367277315wenxingcui@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2019

First Posted

February 18, 2020

Study Start

September 21, 2019

Primary Completion

September 21, 2020

Study Completion

December 21, 2020

Last Updated

February 18, 2020

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)