- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04322721
Coagulopathy on the First Postoperative Day Predicts the Long-term Survival of Traumatic Brain Injury Patients
Coagulopathy on the First Postoperative Day Predicts the Long-term Survival of Traumatic Brain Injury Patients: A Retrospective Cohort Study
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710038
- Tandu Hospital, Fourth Military Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Take anticoagulants or antiplatelet drugs
- Hemorrhagic or ischemic cerebrovascular disease occurred within six months
- Other systemic diseases: uremia, cirrhosis, malignant tumor, etc
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: 3 month after onset
|
The mortality rate of traumatic brain injury (TBI) patients undertook surgery at 3 month
|
3 month after onset
|
Mortality
Time Frame: 12 month after onset
|
The mortality rate of traumatic brain injury (TBI) patients undertook surgery at 12 month
|
12 month after onset
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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. Erratum In: Lancet. 2017 Jan 7;389(10064):e1.
- 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.
- 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.
- Stein SC, Smith DH. Coagulopathy in traumatic brain injury. Neurocrit Care. 2004;1(4):479-88. doi: 10.1385/NCC:1:4:479.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Hematologic Diseases
- Hemorrhagic Disorders
- Craniocerebral Trauma
- Trauma, Nervous System
- Hemostatic Disorders
- Blood Coagulation Disorders
- Brain Injuries
- Wounds and Injuries
- Brain Injuries, Traumatic
Other Study ID Numbers
- TDSJWKTBISC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Traumatic Brain Injury
-
Fondazione per la Ricerca Ospedale MaggioreCompletedBrain Injuries, Traumatic | Brain Injury Traumatic Severe | Brain Injury Traumatic ModerateItaly
-
Toronto Rehabilitation InstituteCentre for Aging and Brain Health Innovation; Ontario Neurotrauma FoundationUnknownBrain Injuries, Traumatic | Brain Injury, Chronic | Brain Injury Traumatic Severe | Brain Injury Traumatic ModerateCanada
-
Hospital Sirio-LibanesUniversity of Sao Paulo; Ministry of Health, Brazil; Hospital Sao Rafael; PROAD... and other collaboratorsRecruitingBrain Injury Traumatic Severe | Brain Injury Traumatic Moderate | Post Traumatic EpilepsyBrazil
-
University of TurkuTurku University Hospital; The Finnish Funding Agency for Technology and Innovation... and other collaboratorsCompletedBrain Injuries | TBI (Traumatic Brain Injury) | Brain Injuries, Traumatic | Traumatic Brain Injury | Injury, Brain, TraumaticFinland
-
Children's Hospital Medical Center, CincinnatiUniversity of CincinnatiCompletedBrain Injury Traumatic MildUnited States
-
BrainScope Company, Inc.RecruitingTBI (Traumatic Brain Injury) | Concussion, Brain | MTBI - Mild Traumatic Brain Injury | Closed Head InjuryUnited States
-
Institut National de la Santé Et de la Recherche...Institut National de Recherche en Informatique et en AutomatiqueNot yet recruitingTBI (Traumatic Brain Injury)France
-
University of Sao Paulo General HospitalUnknownTraumatic Brain Injury | Severe Brain Injury | Closed Traumatic Brain InjuryBrazil
-
Queen Mary University of LondonCompleted
-
First Affiliated Hospital Xi'an Jiaotong UniversityXijing Hospital; Second Affiliated Hospital of Wenzhou Medical University; Central... and other collaboratorsRecruitingMTBI - Mild Traumatic Brain Injury | Moderate Traumatic Brain InjuryChina