Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2025-12-24 @ 1:48 PM
Study NCT ID:
NCT04100395
Status:
NOT_YET_RECRUITING
Last Update Posted:
2019-09-24
First Post:
2019-09-20
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Global Hemostasis Monitoring by Using Sonoclot Signature in Traumatic Patients
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Global Hemostasis Monitoring in Patients With Severe Trauma Using Sonoclot Signature Compared to Conventional Coagulation and Platelet Parameters
Status:
NOT_YET_RECRUITING
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: