NCT04100395

Brief Summary

  1. 1.Analyzing the effects of severe trauma using sonoclot analyzer (which depicts the entire hemostatic pathway) ,subsequently describing the convenient therapy .
  2. 2.Assessing the correlations between sonoclot variables and conventional coagulation and platelet function tests

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
78mo left

Started Sep 2019

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress51%
Sep 2019Oct 2032

Study Start

First participant enrolled

September 15, 2019

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2022

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2032

Expected
Last Updated

September 24, 2019

Status Verified

September 1, 2019

Enrollment Period

3.1 years

First QC Date

September 20, 2019

Last Update Submit

September 20, 2019

Conditions

Study of Hemostatic Profile in Traumatic Patients

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

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.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study will be done on patients sample

You may qualify if:

  • Patients \>18 years.
  • Both sexes will be included.
  • Recent trauma

You may not qualify if:

  • patients \<18 years.
  • Patients with documented evidence of coagulopathy or bleeding diocese .
  • Patients with liver disease.
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Dalia Hesham, master

CONTACT

01149936172daliahesham17793@yahoo.com

Nabila Thabet

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident physician

Study Record Dates

First Submitted

September 20, 2019

First Posted

September 24, 2019

Study Start

September 15, 2019

Primary Completion

October 15, 2022

Study Completion (Estimated)

October 15, 2032

Last Updated

September 24, 2019

Record last verified: 2019-09