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

March 24, 2020 updated by: Tang-Du Hospital

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.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

447

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710038
        • Tandu Hospital, Fourth Military Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

Tang-Du Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Actual)

January 31, 2020

Study Completion (Actual)

January 31, 2020

Study Registration Dates

First Submitted

March 24, 2020

First Submitted That Met QC Criteria

March 24, 2020

First Posted (Actual)

March 26, 2020

Study Record Updates

Last Update Posted (Actual)

March 26, 2020

Last Update Submitted That Met QC Criteria

March 24, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TDSJWKTBISC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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