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NCT Number: NCT04100395

Global Hemostasis Monitoring by Using Sonoclot Signature in Traumatic Patients

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

About this study

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

  • coagulopathy secondary to hemorrhagic shock due to massive bleeding and
  • 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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sonoclot

Device

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 outcomes

  1. global monitoring of coagulation profile

    Time frame: baseline

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Dalia Hesham, master

CONTACT

[email protected]

01149936172

Nabila Thabet

CONTACT

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2032
First posted
Sep 24, 2019
Registry last updated
Sep 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.