Coagulation analysis with ROTEM sigma versus ROTEM delta in liver transplantatio

Recruiting

• Conditions: All patients are eligible for liver transplantation, including whole organ transplantation, split liver transplantation and retransplantation.

• Registration Number: DRKS00034207
• Lead Sponsor: niversitätsklinum Essen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

All consenting adult patients undergoing liver transplantation at the University Hospital Essen will be included. Although this includes women of childbearing potential who are not using contraception, a medical implication is excluded as this is a non-interventional study.

Exclusion Criteria

Lack of capacity to consent in patients who are minors.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Are the results of viscoelastic coagulation analysis using the newer ROTEM sigma rotational thrombelastometer in the context of liver transplantation comparable to the previous clinical standard ROTEM delta device.<br>To test the correlation between the clotting time (CT) in the extrinsically activated EXTEM assay with Quick/INR, the CT in the intrinsically activated INTEM assay with aPTT, and the clot strength at 5 minutes (amplitude at 5 min, A5) and total clot firmness (maximum clot firmness, MCF) in the extrinsically activated FIBTEM assay under in vitro platelet function inhibition with Clauss fibrinogen concentration compared to ROTEM sigma and ROTEM delta.<br>Can FXIII deficiency be unmasked by viscoelastic testing.

Secondary Outcome Measures

Name	Time	Method
The aim is to compare whether the handling of the ROTEM sigma offers advantages for the user. For this purpose, the pre-analysis time and the time to the first measured values are compared for both methods.<br>Clinical relevance of FXIII deficiency in liver transplant patients both early (transfusion requirement) and mid-term (wound healing disorders) after liver transplantation.