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Traumatic Brain InjuryNCT04322721

Coagulopathy on the First Postoperative Day Predicts the Long-term Survival of Traumatic Brain Injury Patients

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

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Traumatic Brain Injury, Coagulation Disorder
How many people
447 participants
Where
1 siteChina
Study dates
1 Oct 2019to 31 Jan 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
  • Adult, Older adult

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.

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Tandu Hospital, Fourth Military Medical University

    Xi'an, Shaanxi, 710038

Other trials in China

About this study

Official title: Coagulopathy on the First Postoperative Day Predicts the Long-term Survival of Traumatic Brain Injury Patients: A Retrospective Cohort Study

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.

Read the detailed description

Traumatic brain injury (TBI) is one of the leading causes of death and disability worldwide, and it represents a global health concern and financial burden [1, 2]. The main causes of early death in trauma victims are acidosis, hypothermia and coagulopathy, which are related to each other and influence each other. Thus, this vicious circle is often referred to as the " trauma triangle of death " [3, 4]. Trauma-induced coagulopathy manifests as a state of hypercoagulopathy trending towards thrombosis [5] and a state of hypocoagulopathy with progressive intracranial hemorrhage and increased systemic bleeding [6, 7].

There are many studies continuously proving that trauma-induced coagulopathy is common in traumatic brain injury patients [8-10] and the incidence of coagulation disorders has great heterogeneity, ranging from 7% to 54% [11, 12]. Reasons that cause this variation include the different techniques and definitions used, the heterogeneity of the patients and the various testing times [13]. Secondary coagulopathy after traumatic brain injury represent an important factor for unfavorable prognosis [14, 15], resulting in a nine-fold higher risk of death and a 30-fold higher risk of poor prognosis than in TBI patients without secondary coagulation disorder [7, 9, 16]. Mortality in TBI patients with coagulopathy is also highly heterogeneous, ranging from 22% to 66% [17, 18]. TBI patients with coagulopathy tend to suffer from delayed or progressive intracranial hemorrhage, as well as from microvascular thrombosis [19, 20].

Many retrospective and observational studies have focused on coagulation upon admission or the presence of any coagulation disorders during the whole period of hospitalization [21, 22]. A multicenter study described the course of coagulopathy in patients with isolated TBI, and associated it with CT characteristics and outcomes [15]. The previous study mostly focused on the coagulopathy on admission, while the association between coagulopathy in perioperative period and long-term survival of TBI patients has not been explored. It is important to explore this relationship because many TBI patients require surgical treatment, and it has been well established that the surgical intervention have an impact on the coagulation functions. We therefore investigated for the first time whether coagulopathy during the perioperative period, with the use of coagulation function tests performed before the operation and on the first day after the operation, was related to the long-term survival of these patients. Furthermore, we investigated the predisposing risk factors that may cause coagulopathy in the perioperative period, to the extent that these risk factors could be controlled and managed for avoiding coagulopathy.

Keywords
Traumatic Brain Injury, Coagulation Disorder
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. Mortality

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

    Measured: 3 month after onset

  2. Mortality

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

    Measured: 12 month after onset

Timeline

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

  1. First posted26 Mar 2020
  2. Study start1 Oct 2019
  3. Primary completion31 Jan 2020
  4. Study completion31 Jan 2020

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
Other
Time perspective
Retrospective
Enrolment
447 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04322721
Sponsor's protocol ID
TDSJWKTBISC
Status last verified
Mar 2020
First submitted
24 Mar 2020
Last updated
26 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27733282

  • 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.

    PubMed 16983222

  • 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.

    PubMed 27365740

  • 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.

    PubMed 21785151

  • 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.

    PubMed 23984395

  • 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.

    PubMed 22307074

  • 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.

    PubMed 28721927

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

    PubMed 16174954

  • 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

  • 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.

    PubMed 23020190

  • 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.

    PubMed 21045504

  • 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.

    PubMed 21208418

  • 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.

    PubMed 29848170

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 4 inclusion and 3 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: finished, as of the sponsor's last update on 26 Mar 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (time frame: 3 month after onset). 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 NCT04322721, which also lists 13 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 26 Mar 2020.

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