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

Completed

• Conditions: Traumatic Brain Injury; Coagulation Disorder

• Registration Number: NCT04322721
• Lead Sponsor: Tang-Du Hospital

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.

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 Timeline

• Study Start: 2019-10-01
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31
• Status Verified: 2020-03
• Study First Submitted: 2020-03-24
• Study First Submitted QC: 2020-03-24
• Last Update Submitted: 2020-03-24
• Study First Posted: 2020-03-26
• Last Update Posted: 2020-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 447

Inclusion Criteria

1. The interval between injury and admission is less than 24 hours
2. Age>18yrs and age<80yrs
3. Non-head abbreviated injury score < 3
4. Did not undertake treatment before enrollment

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	12 month after onset	The mortality rate of traumatic brain injury (TBI) patients undertook surgery at 12 month

Trial Locations

Locations (1)

Tandu Hospital, Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China