To investigate the in vitro effect of both pro- and anticoagulation therapy on thrombin generation by Calibrated Automated Thrombography in plasma from patients with cirrhosis undergoing liver transplantation.
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
- Vascular therapeutic procedures
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Thrombin generation by Calibrated Automated Thrombinography.
Secondary outcome
Other study parameters are individual coagulation factors, Prothrombin Time
(PT), International Normalized Ratio (INR), Activated Partial Thromboplastin
Time (APTT), Fibrinogen, Platelet count and Hemoglobin (Hb). Moreover,
indicators of liver function such as Gamma-Glutamyl Transpeptidase (GGT),
Asparate Aminotransferase (ALT) Alanine Transaminase (AST), ammonia (NH3),
alpha1 antitrypsin and ceruloplasmin are study parameters.
Background summary
Patients with liver disease are at risk for both bleeding and thrombotic
complications, and this risk further increases in patients undergoing liver
transplant surgery. Little clinical data on efficacy and safety of pro- and
antihemostatic drugs in patients undergoing liver transplantation are
available. We aim to assess the in vitro efficacy of both pro- and
anticoagulant drugs by comparing thrombin generation curves (considering
thrombin generation lag time, time to peak thrombin generation, peak thrombin
generation, and endogenous thrombin potential) generated in plasma taken from
patients during and after liver transplantation, with thrombin generation
curves generated in the plasma of healthy volunteers. Various pro- and
anticoagulant drugs will be added to these plasma samples in vitro. The
percentual change in parameters of the thrombin generation curve after addition
of a fixed dose of a pro- or anticoagulant drugs is the primary endpoint of the
study. This study may help guide the dosage of these drugs in these patients
during and after transplantation. Moreover, it may prevent overdosing with the
risk of unwarranted complications (e.g. bleeding or thrombosis).
Study objective
To investigate the in vitro effect of both pro- and anticoagulation therapy on
thrombin generation by Calibrated Automated Thrombography in plasma from
patients with cirrhosis undergoing liver transplantation.
Study design
A prospective cohort, mono-center study.
Study burden and risks
Blood samples from the healthy volunteers will be taken once via venapunction.
During the liver transplantation, blood samples will be taken at the same time
blood samples for routine care will be withdrawn via an arterial line.
Venapunction is associated with minor discomfort and can cause local bruising.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
Orthotopic Liver Transplantation for cirrhosis at the UMCG
Age >18 years
Signed informed consent
Exclusion criteria
Acute liver failure
Documented history of hereditary thrombophilia
Use of vitamin K antagonists
Transfusion of blood products (<7 days)
Deep venous thrombosis (<30 days)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL53151.042.15 |