Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06635564
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-27
Brief Title:
Personalized ViscoElastic Testing-guided Bleeding Management in Liver Surgery Neurosurgery and Obstetrics
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Personalized ViscoElastic Testing-guided Bleeding Management in Liver Surgery Neurosurgery and Obstetrics - a Prospective Comparison of the Novel ClotPro with ROTEM and TEG
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VETILNO
Brief Summary:
The ClotPro analyzer is a new generation viscoelastic analyzer for the in vitro assessment of blood coagulation This study aims to assess the agreement of ClotPro 60 ROTEM delta and TEG 6s in three distinct cohorts i patients with liver disease undergoing liver surgery ii pregnant women undergoing elective cesarean section and iii patients undergoing elective intracranial neurosurgery Further coagulation tests will be performed standard laboratory coagulation tests thrombin and plasmin generation tests in an exploratory fashion to compare them with viscoelastic test results The obtained test results will not result in any diagnostic or therapeutic consequences for patients included in this study
Detailed Description:
The primary research question is therefore to compare various parameters of standard ClotPro measurements with corresponding ROTEM delta and TEG 6s parameters
Additionally this study aims to close the following clinically important knowledge gaps
Do VET results mirror measurements obtained by more holistic in-depth analyses of the hemostatic system that are currently not available in clinical practice such as TGA-TM and PG
Which of the three investigated VET devices offers the most rapid availability of diagnostic results
Do VET results have a predictive ability for the occurrence of perioperative bleeding andor thromboembolic events
Do VET results depict sex-specific differences in perioperative coagulation management
Furthermore by including a large number of patients from three distinct patient cohorts this study intends to examine whether cohort-specific reference ranges need to be established for ClotPro Thereby this study aims to provide the foundation for an evidence-based ClotPro-guided perioperative coagulation management algorithm which could upscale current opportunities of personalizing perioperative coagulation management
Additionally this study aims to close the following clinically important knowledge gaps
Do VET results mirror measurements obtained by more holistic in-depth analyses of the hemostatic system that are currently not available in clinical practice such as TGA-TM and PG
Which of the three investigated VET devices offers the most rapid availability of diagnostic results
Do VET results have a predictive ability for the occurrence of perioperative bleeding andor thromboembolic events
Do VET results depict sex-specific differences in perioperative coagulation management
Furthermore by including a large number of patients from three distinct patient cohorts this study intends to examine whether cohort-specific reference ranges need to be established for ClotPro Thereby this study aims to provide the foundation for an evidence-based ClotPro-guided perioperative coagulation management algorithm which could upscale current opportunities of personalizing perioperative coagulation management
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None