Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2026-01-25 @ 11:53 PM
Study NCT ID:
NCT04107818
Status:
COMPLETED
Last Update Posted:
2024-05-22
First Post:
2019-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Viscoelastic Measurement by ROTEM® Delta and ClotPro® in Trauma Patients.
Sponsor:
Masaryk University
Organization:
Study Overview
Official Title:
Comparison of Viscoelastic Measurement by ROTEM® Delta and ClotPro® in Trauma Patients. Prospective Observational Study.
Status:
COMPLETED
Status Verified Date:
2024-05
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:
ROTCLOT
Brief Summary:
The purpose of the study is to describe the differences and interchangeability in measurements of viscoelastic tests of coagulation by two different devices in adult trauma patients.
Detailed Description:
The study will commence following the Approval by The Ethics Research Committee. All patients admitted to our emergency department for trauma from the 1st of October 2019 to the 31st of January 2020 will be enrolled after fulfilling the inclusion criteria and in the absence of any exclusion criteria. Informed consent will be requested. Viscoelastic tests of coagulation will be performed on ROTEM® Delta and ClotPro® simultaneously. We will compare values of clotting time (CT), clot formation time (CFT), alfa angle, maximum clot firmness (MCF) and maximum lysis (ML) for test of extrinsic pathway(EX-test) on ClotPro® vs. test for extrinsic pathway (EXTEM) on ROTEM® Delta. Further we will compare values of clotting time (CT), clot formation time (CFT), alfa angle, maximum clot firmness (MCF) and maximum lysis (ML) for thromboelastometry of fibrinogen (FIB-test) on ClotPro® vs. thromboelastometry of fibrinogen (FIBTEM) on ROTEM® Delta. The secondary outcome will be to describe the dependence of measurement on temperature of patient.
Study data will be entered in study form. The measurements can be repeated in time. The indication for next measurement is fully on treating physician.
Differences in estimated viscoelastic coagulation parameters and interchangeability of two devices will be analysed.
Study data will be entered in study form. The measurements can be repeated in time. The indication for next measurement is fully on treating physician.
Differences in estimated viscoelastic coagulation parameters and interchangeability of two devices will be analysed.
Study Oversight
Has Oversight DMC:
False
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?: