To assess hemostatic balance in pediatric patients before, during and after liver transplantation by comparing routine diagnostic laboratory tests with more advanced tests such as thromboelastography and thrombin generation tests.
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
- Hepatobiliary therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Routine diagnostic tests of hemostasis (platelet count, prothrombin time),
thrombin generation tests, and thromboelastography.
Secondary outcome
Not applicable.
Background summary
In both adult and pediatric patients with end-stage liver disease the only
curative treatment is liver transplantation. Both bleeding and thrombosis can
complicate pediatric liver transplantation and contributing to significant
morbidity and mortality. Compared to adults, pediatrics are at greater risk for
developing post-transplant vascular complications.
In patients with liver diseases routine laboratory tests such as the
prothrombin time and the platelet count, frequently are suggestive of a
hypocoagulable state, while with more sophisticated laboratory tests it has
been shown that adult patients with liver disease are in hemostatic balance as
a result of concurrent changes in both pro- and antihemostatic pathways. The
*rebalanced hemostasis* of patients with liver disease, however, is fragile and
can relatively easily be tipped toward both bleeding and thrombosis. Previous
studies showed that during liver transplantation the hemostatic system changes
even more as pro- and anticoagulant factors decrease even further. Up to now,
little data on the hemostatic balance in pediatric patients with liver disease
are available, and no data on the changes in hemostasis during pediatric liver
transplantation are available.
More knowledge of the hemostatic status in pediatric patients with liver
failure during and after transplantation is required to safely and efficiently
treat and prevent both bleeding and thrombotic complications in these patients.
Study objective
To assess hemostatic balance in pediatric patients before, during and after
liver transplantation by comparing routine diagnostic laboratory tests with
more advanced tests such as thromboelastography and thrombin generation tests.
Study design
A single center prospective cohort study.
Study burden and risks
Burden and risks of this study are negligible. Collection of blood samples will
be performed from an arterial line at time points at which blood samples are
also taken for routine clinical care. Therefore, no extra venapunction or
intervention is necessary to obtain the blood samples required for our study in
the study population. Taking these routine blood samples carries limited risks
and are usually well tolerated. Blood samples from the healthy pediatrics will
be taken once via venapunction during the planned anesthesia for the minor
surgical procedure. Venapunction is associated with minimal discomfort and can
cause local bruising.
The benefit of this study on the long term, is that participating in this trial
will give both researchers and physicians better understanding of the
hemostatic status in patients with liver failure during and after
transplantation. This knowledge is required for a more rational approach to
prevention and treatment of bleeding and thrombotic complications in these
patients.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
Study group
- Patients that undergo orthotopic liver transplantation for any reason at the UMCG, except patients with acute liver failure
- Livers from all sort of donors will be included, including living donor livers
- In the period from june 2017 to june 2018
- Signed informed consent (patients and/or parents/guardian);Control group
- Healthy patients that undergo minor surgery at the UMCG
Minor surgery includes inguinal operations and excision of soft tissue tumours other than malignancy, like a cyst, hemangioma or lipoma.
- In the period from june 2017 to june 2018
- Matched 2:1 with the study group population for age
- Signed informed consent (patients and/or parents/guardian)
Exclusion criteria
Study group
- Age > 16 years
- No informed consent obtained
- Diagnose of acute liver failure;Control group
- Age > 16 years
- No informed consent obtained
- Any comorbidities or pre-term birth
- Use of medication that influences liver function or hemostasis
- History of thrombotic events or bleeding
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 | NL61164.042.17 |