An observational study in Traumatic Brain Injury and Coagulation Disorder, sponsored by Tang-Du Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-03-26.
Sponsored by Tang-Du Hospital · Observational
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.
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.
1,818 studies on the registry are indexed under Brain Injuries, Traumatic; 460 are open to participants now.
This study's enrollment of 447 is above the median of 119 across 579 observational studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →Tang-Du Hospital is the lead sponsor of 166 studies on the registry; 77 are open to participants now.
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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.
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Exclusion Criteria:
Mortality
The mortality rate of traumatic brain injury (TBI) patients undertook surgery at 3 month
Time frame: 3 month after onset
Mortality
The mortality rate of traumatic brain injury (TBI) patients undertook surgery at 12 month
Time frame: 12 month after onset
Plan to share: No
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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