Study of Hemostatic Profile in Traumatic PatientsNCT04100395
Global Hemostasis Monitoring by Using Sonoclot Signature in Traumatic Patients
An observational study of Study of Hemostatic Profile in Traumatic Patients, run by Assiut University.
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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Study of Hemostatic Profile in Traumatic Patients
- What is being tested?
- sonoclot
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2019to 15 Oct 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
Study population: Study will be done on patients sample
Who may be able to join
- -Patients >18 years.
- Both sexes will be included.
- Recent trauma
Who cannot join
- -patients <18 years.
- Patients with documented evidence of coagulopathy or bleeding diocese .
- Patients with liver disease.
- Pregnant women
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Nabila Thabet contact
About this study
Official title: Global Hemostasis Monitoring in Patients With Severe Trauma Using Sonoclot Signature Compared to Conventional Coagulation and Platelet Parameters
- Analyzing the effects of severe trauma using sonoclot analyzer (which depicts the entire hemostatic pathway) ,subsequently describing the convenient therapy .
- Assessing the correlations between sonoclot variables and conventional coagulation and platelet function tests
Read the 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
- 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
- Being tested
- sonoclot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sonoclotDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start15 Sep 2019 (estimated)
- Primary completion15 Oct 2022 (estimated)
- Study completion15 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Study of Hemostatic Profile in Traumatic PatientsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DO Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100395
- Sponsor's protocol ID
- sonoclot signature
- Status last verified
- Sep 2019
- First submitted
- 20 Sep 2019
- Last updated
- 24 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Hemostasis Monitoring in Patients With Severe Trauma Using Sonoclot Signature Compared to Conventional Coagulation and Platelet Parameters
- ClinicalTrials.gov ID
- NCT04100395
- Acronym / sponsor ID
- sonoclot signature
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Sep 2019 (estimated)
- Primary completion
- 15 Oct 2022 (estimated)
- Study completion
- 15 Oct 2032 (estimated)
- First posted
- 24 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Analyzing the effects of severe trauma using sonoclot analyzer (which depicts the entire hemostatic pathway) ,subsequently describing the convenient therapy .
- 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
- 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
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Study will be done on patients sample
Key inclusion criteria (3 listed)
- -Patients >18 years.
- Both sexes will be included.
- Recent trauma
Key exclusion criteria (4 listed)
- -patients <18 years.
- Patients with documented evidence of coagulopathy or bleeding diocese .
- Patients with liver disease.
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sonoclotSonoclot 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. | Device | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nabila Thabet contact
Questions about this trial
What is this clinical trial studying?
An observational study of Study of Hemostatic Profile in Traumatic Patients, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dalia Hesham, master (01149936172, daliahesham17793@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
global monitoring of coagulation profile (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2019.