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Coagulation analysis with ROTEM sigma versus ROTEM delta in liver transplantation

Coagulation analysis with ROTEM sigma versus ROTEM delta in liver transplantation - ROSI in LTX

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00034207
Enrollment
100
Registered
2024-07-15
Start date
2024-06-13
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Group 1: It is a monocentric, non-interventional, clinical obeservation study in the context of liver transplantation.

Sponsors

Universitätsklinum Essen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria: Lack of capacity to consent in patients who are minors.

Design outcomes

Primary

MeasureTime frame
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. 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. Can FXIII deficiency be unmasked by viscoelastic testing.

Secondary

MeasureTime frame
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. Clinical relevance of FXIII deficiency in liver transplant patients both early (transfusion requirement) and mid-term (wound healing disorders) after liver transplantation.

Countries

Germany

Contacts

Public ContactBjörn Breuing

Universitätsklinikum Essen

bjoern.breuing@uk-essen.de+4920172384042

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026