NCT04322721

Brief Summary

The purpose of this study was to identify the relationship between coagulopathy during the perioperative period (before the operation and on the first day after the operation) and the long-term survival of traumatic brain injury patients undergoing surgery, as well as to explore the predisposing risk factors that may cause perioperative coagulopathy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
447

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2020

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

4 months

First QC Date

March 24, 2020

Last Update Submit

March 24, 2020

Conditions

Traumatic Brain InjuryCoagulation Disorder

Keywords

Traumatic Brain InjuryCoagulation Disorder

Outcome Measures

Primary Outcomes (2)

  • Mortality

    The mortality rate of traumatic brain injury (TBI) patients undertook surgery at 3 month

    3 month after onset

  • Mortality

    The mortality rate of traumatic brain injury (TBI) patients undertook surgery at 12 month

    12 month after onset

Eligibility Criteria

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

The clinical data of TBI patients were retrospectively collected from January 1, 2015 to April 25, 2019 in the Second Affiliated Hospital of the Fourth Military Medical University. We included patients who recorded an intracranial injury as the main diagnosis or the coexisting diagnoses upon admission. Intracranial injuries were identified by WHO ICD-11 codes from NA07.0 to NA07.9.

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

You may not qualify if:

  • Take anticoagulants or antiplatelet drugs
  • Hemorrhagic or ischemic cerebrovascular disease occurred within six months
  • Other systemic diseases: uremia, cirrhosis, malignant tumor, etc

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tandu Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710038, China

Location

Related Publications (13)

  • GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1545-1602. doi: 10.1016/S0140-6736(16)31678-6.

    PMID: 27733282BACKGROUND

  • Langlois JA, Rutland-Brown W, Wald MM. The epidemiology and impact of traumatic brain injury: a brief overview. J Head Trauma Rehabil. 2006 Sep-Oct;21(5):375-8. doi: 10.1097/00001199-200609000-00001.

    PMID: 16983222BACKGROUND

  • Dadhwal US, Pathak N. Damage Control Philosophy in Polytrauma. Med J Armed Forces India. 2010 Oct;66(4):347-9. doi: 10.1016/S0377-1237(10)80015-2. Epub 2011 Jul 21.

    PMID: 27365740BACKGROUND

  • Mitra B, Tullio F, Cameron PA, Fitzgerald M. Trauma patients with the 'triad of death'. Emerg Med J. 2012 Aug;29(8):622-5. doi: 10.1136/emj.2011.113167. Epub 2011 Jul 23.

    PMID: 21785151BACKGROUND

  • Chen H, Xue LX, Guo Y, Chen SW, Wang G, Cao HL, Chen J, Tian HL. The influence of hemocoagulation disorders on the development of posttraumatic cerebral infarction and outcome in patients with moderate or severe head trauma. Biomed Res Int. 2013;2013:685174. doi: 10.1155/2013/685174. Epub 2013 Aug 4.

    PMID: 23984395BACKGROUND

  • Laroche M, Kutcher ME, Huang MC, Cohen MJ, Manley GT. Coagulopathy after traumatic brain injury. Neurosurgery. 2012 Jun;70(6):1334-45. doi: 10.1227/NEU.0b013e31824d179b.

    PMID: 22307074BACKGROUND

  • Maegele M, Schochl H, Menovsky T, Marechal H, Marklund N, Buki A, Stanworth S. Coagulopathy and haemorrhagic progression in traumatic brain injury: advances in mechanisms, diagnosis, and management. Lancet Neurol. 2017 Aug;16(8):630-647. doi: 10.1016/S1474-4422(17)30197-7. Epub 2017 Jul 11.

    PMID: 28721927BACKGROUND

  • Stein SC, Smith DH. Coagulopathy in traumatic brain injury. Neurocrit Care. 2004;1(4):479-88. doi: 10.1385/NCC:1:4:479.

    PMID: 16174954BACKGROUND

  • 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

  • Zhang J, Jiang R, Liu L, Watkins T, Zhang F, Dong JF. Traumatic brain injury-associated coagulopathy. J Neurotrauma. 2012 Nov 20;29(17):2597-605. doi: 10.1089/neu.2012.2348. Epub 2012 Oct 31.

    PMID: 23020190BACKGROUND

  • Chhabra G, Rangarajan K, Subramanian A, Agrawal D, Sharma S, Mukhopadhayay AK. Hypofibrinogenemia in isolated traumatic brain injury in Indian patients. Neurol India. 2010 Sep-Oct;58(5):756-7. doi: 10.4103/0028-3886.72175.

    PMID: 21045504BACKGROUND

  • Greuters S, van den Berg A, Franschman G, Viersen VA, Beishuizen A, Peerdeman SM, Boer C; ALARM-BLEEDING investigators. Acute and delayed mild coagulopathy are related to outcome in patients with isolated traumatic brain injury. Crit Care. 2011;15(1):R2. doi: 10.1186/cc9399. Epub 2011 Jan 5.

    PMID: 21208418BACKGROUND

  • Kumar MA, Cao W, Pham HP, Raju D, Nawalinski K, Maloney-Wilensky E, Schuster J, Zheng XL. Relative Deficiency of Plasma A Disintegrin and Metalloprotease with Thrombospondin Type 1 Repeats 13 Activity and Elevation of Human Neutrophil Peptides in Patients with Traumatic Brain Injury. J Neurotrauma. 2019 Jan 15;36(2):222-229. doi: 10.1089/neu.2018.5696. Epub 2018 Aug 14.

    PMID: 29848170BACKGROUND

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 Design

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

Study Record Dates

First Submitted

March 24, 2020

First Posted

March 26, 2020

Study Start

October 1, 2019

Primary Completion

January 31, 2020

Study Completion

January 31, 2020

Last Updated

March 26, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)