Menu
Not yet recruiting NCT04100395

Global Hemostasis Monitoring by Using Sonoclot Signature in Traumatic Patients

Observational Study of Hemostatic Profile in Traumatic Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: sonoclot.
Who it may be relevant to
Registry conditions: Study of Hemostatic Profile in Traumatic Patients. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Global Hemostasis Monitoring in Patients With Severe Trauma Using Sonoclot Signature Compared to Conventional Coagulation and Platelet Parameters

Overview

1. Analyzing the effects of severe trauma using sonoclot analyzer (which depicts the entire hemostatic pathway) ,subsequently describing the convenient therapy . 2. Assessing the correlations between sonoclot variables and conventional coagulation and platelet function tests

Detailed description

Coagulopathy is a physiological response to massive bleeding that frequently occurs after severe trauma and is an independent predictive factor for mortality\[2\]. . There are two of the major causes of coagulopathy in trauma patients

1. coagulopathy secondary to hemorrhagic shock due to massive bleeding and 2. coagulopathy secondary to severe head injury\[3\] which results in release of tissue factor from damaged brain tissue.

Therefore, it is very important to grasp the coagulation status of patients with severe trauma quickly and accurately with objective indicator in order to establish the therapeutic strategy .

The importance of viscoelastic devices in understanding the disease condition of patients with traumatic coagulopathy has been widely recognized in Europe. Viscoelastic hemostatic assays devices have practical advantages as point-of-care devices for monitoring major hemorrhage including speed of results and a set of parameters that assesses a global coagulation profile .

Also In the USA, Massive Transfusion in Trauma Guidelines proposed by the American College of Surgeons in 2013 presented the test results obtained by the viscoelastic devices, as the standard for transfusion or injection of blood plasma, cryoprecipitate, platelet concentrate, or anti-fibrinolytic agents in the treatment strategy for traumatic coagulopathy and hemorrhagic shock .

However, some studies have reported limitations of these viscoelastic devices

Interventions

  • Device sonoclot
    Sonoclot Analyzer is best described as a microviscometer. The electronics are sensitive to any resistance to motion that the oscillating probe encounters as it moves within the test sample.

Primary outcome measures

  • global monitoring of coagulation profile [Time frame: baseline]

Eligibility criteria

Inclusion criteria

  • -Patients >18 years.
  • Both sexes will be included.
  • Recent trauma

Exclusion criteria

  • -patients <18 years.
  • Patients with documented evidence of coagulopathy or bleeding diocese .
  • Patients with liver disease.
  • Pregnant women

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-control

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT04100395 · sonoclot signature

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗