Global Hemostasis Monitoring by Using Sonoclot Signature in Traumatic Patients

Study of Hemostatic Profile in Traumatic Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04100395
• Other study ID #: sonoclot signature
• Status: Not yet recruiting
• Start date: September 15, 2019
• Est. completion date: October 15, 2032

Study information

• Verified date: September 2019
• Source: Assiut University
• Contact: Dalia Hesham, master
• Phone: 01149936172
• Email: daliahesham17793[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: October 15, 2032
• Est. primary completion date: October 15, 2022
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Study of Hemostatic Profile in Traumatic Patients

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	global monitoring of coagulation profile	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	baseline