Global Hemostasis Monitoring by Using Sonoclot Signature in Traumatic Patients

September 20, 2019 updated by: DO Ahmed, Assiut University

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

  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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Nabila Thabet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study will be done on patients sample

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 15, 2019

Primary Completion (ANTICIPATED)

October 15, 2022

Study Completion (ANTICIPATED)

October 15, 2032

Study Registration Dates

First Submitted

September 20, 2019

First Submitted That Met QC Criteria

September 20, 2019

First Posted (ACTUAL)

September 24, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 24, 2019

Last Update Submitted That Met QC Criteria

September 20, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • sonoclot signature

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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