Global Hemostasis Monitoring by Using Sonoclot Signature in Traumatic Patients

NCT ID: NCT04100395

Last Updated: 2019-09-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-15
• Study Completion Date: 2032-10-15

Brief 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

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

Conditions

Study of Hemostatic Profile in Traumatic Patients

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

DO Ahmed

Resident physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Dalia Hesham, master

Role: CONTACT

daliahesham17793@yahoo.com

01149936172

Nabila Thabet

Role: CONTACT

Other Identifiers

sonoclot signature

Identifier Type: -

Identifier Source: org_study_id